Anda di halaman 1dari 154

Buyers’ guide

Nebulizers
CEP09018

October 2009
Contents 2

Introduction ............................................................................................. 3

Technical considerations ......................................................................... 7

Operational considerations.................................................................... 13

Economic considerations ...................................................................... 15

Purchasing ............................................................................................ 17

Market review........................................................................................ 19

Jet nebulizer chambers ...................................................................................... 21


Jet nebulizer and compressor systems ................................................................. 56
Vibrating membrane or mesh nebulizers ............................................................... 77
Ultrasonic nebulizers ............................................................................................. 83
Summary of evidence............................................................................................ 90
Choosing a nebulizer........................................................................................... 101

Acknowledgements ............................................................................. 102

Glossary .............................................................................................. 103

References.......................................................................................... 104

Appendix 1: Summary of evidence ...................................................... 115

Appendix 2: Supplier contact details ................................................... 146

Appendix 3: EU procurement procedure ............................................. 151

Author and report information.............................................................. 154

CEP09018: October 2009


Introduction 3

Nebulizers are used for the administration of drug therapy by inhalation of liquid
medicine in the form of an aerosol. The nebulizer is the chamber that holds the drug
and the nebulizing system provides the means to create a fine mist of an appropriate
composition for delivery to the patient's airway or lungs. There are currently three
types of nebulizer system: jet nebulizers driven by a compressed airflow, ultrasonic
nebulizers and vibrating mesh or membrane nebulizers.

Clinical uses of nebulizers


Nebulized treatment may be considered for three main reasons:

• When a patient requires very high doses of inhaled bronchodilator medication


• If a patient needs an inhaled drug such as an antibiotic which cannot be given
by any other means
• When patients are unable to use conventional methods of drug delivery, such
as in some cases of acute asthma.

The most common application of nebulized therapy is to deliver bronchodilator drugs


to patients with asthma or chronic obstructive pulmonary disease (COPD).

General
This buyers’ guide is intended to assist in the selection of nebulizer chambers and
nebulizer systems for use in both primary and secondary care. Information
comprising manufacturers’ data and evidence of performance is presented in a
standardised format to help purchasers prepare a short-list. The 69 devices in this
guide are representative of the UK market in 2009. Models are presented
alphabetically by manufacturer. Abbreviations used in this report are defined in the
glossary.

Scope
Information is provided for 35 small volume (1-15 ml) nebulizer chambers, 21
compressor driven systems, six vibrating membrane systems and seven ultrasonic
systems. Large volume nebulizers are mostly used to provide humidity to the airway;
only those intended for drug delivery are included in this buyers’ guide. Hand held
pressurised metered dose inhalers (MDI) or dry powder inhalers (DPI) are not
included. Nebulizer chamber prices range from £0.39 for disposable devices to
£33.76 for re-useable devices. Prices for compressor nebulizing systems range from
£42.00 to £225.75, vibrating membrane systems from £87.00 to £495.00 and
ultrasonic systems from £135.00 to £1044.86 excluding accessories, eg mouthpieces
and masks.

CEP09018: October 2009


Introduction 4

National guidance
BTS
The British Thoracic Society (BTS) commissioned a series of reviews of nebulizer
treatment. These reviews included:

• the science of nebulized drug delivery


• nebulizer use in clinical practice
• practical aspects of using nebulizers.

The conclusions from the reviews were published in 1997 as a set of guidelines [1],
for the use of nebulizers in the treatment of specific diseases including asthma,
COPD, cystic fibrosis and HIV/AIDS.

ERS
The European Respiratory Society (ERS) published guidelines [2] in 2001 for clinical
practice in the use of nebulizer therapy. The guidelines provided practical advice for
healthcare professionals in the choice of nebulizer systems based on clinical need
and technical considerations.

The technical part of the guideline discusses the many issues that affect performance
and describes the characteristics of a good nebulizer system as:

• a fast rate of nebulization


• minimum waste of drug aerosol to the environment
• low residual volume, ie more of the volume fill will be delivered to the patient as
drug aerosol
• well-defined droplet size distribution—this affects where in the patient's airway
or lungs the aerosol is deposited.

The guideline recommends that devices are type tested according to the European
Standard EN 13544-1 [3] (originally published in 2001 and revised in 2007) to
measure performance and allow comparison of different nebulizer systems.

CEP09018: October 2009


Introduction 5

British and European standard


BS EN 13544-1:2007 'Respiratory therapy equipment—Part 1: Nebulizing systems
and their components' [3] defines the type tests that manufacturers should carry out
to measure:

• Aerosol output rate


• Aerosol output
• Particle size distribution.

Tests must be implemented using a sodium fluoride (NaF) solution of defined


concentration in the nebulizer chamber of the system under test.

To measure aerosol output rate, 2 ml of 1% sodium fluoride (or the fill volume if less
than 2 ml) is added to the nebulizer chamber. This is assembled into its system and
connected to the test apparatus, which includes an air pump simulating a respiratory
flow rate of 15 breaths per minute. A filter between the nebulizer and the air pump
collects the sodium fluoride aerosol during the test. The nebulizer is switched on for
one minute and the amount of aerosol collected by the filter is quantified enabling the
system output rate (ml/minute) to be calculated.

Aerosol output is measured with the same apparatus. In this case the nebulizer
chamber is filled and then the system operated until nebulization ceases. The total
amount (ml) of aerosol absorbed by the filter can then be quantified.

Particle size distribution is measured by attaching the nebulizer system to a multi-


stage cascade impactor (eg Anderson-Marple series 298). This is a device that
samples the aerosol and passes it through a series of chambers or stages. Each
stage allows only particles up to a certain size to penetrate to the next stage; larger
particles impact onto a substrate. For this measurement the nebulizer is filled with 2
ml of 2.5% sodium fluoride (or the fill volume if less than 2 ml) and switched on. A
suction pump draws the aerosol through the test apparatus for sampling by the
cascade impactor. The relative amounts of aerosol deposited in each stage of the
impactor are measured to create a distribution curve. A typical impactor device can
quantify aerosol particle sizes between 0.4 and 21 microns (µm) in eight stages.

Alternative methods of particle size measurement such as those based on laser


particle diffraction (eg Malvern Mastersizer X) and time-of-flight measures (eg
APS 3310) may be employed provided that validation of the method has been
performed against a cascade impactor demonstrating equivalent particle size
distribution curves and derived results [2].

CEP09018: October 2009


Introduction 6

MHRA Bulletin No. 17: Medical devices and medicinal products


This bulletin [4] sets out the regulation of specific products and distinguishes those
which are regulated as medical devices and those which are regulated as medicinal
products.

Products that incorporate or are used to administer a drug may be regulated as either
medical devices or as medicinal products, depending on the principal intended
function of the product and the method by which this action is achieved. There are
three main types of medical device which incorporate or are used to administer a
medicinal product:

• Devices which are used to administer medicinal products


• Devices for administering medicinal products where the device and the
medicinal product form a single integral product designed to be used
exclusively in the given combination and which are not re-usable or re-fillable
• Devices incorporating, as an integral part, a substance, which, if used
separately, may be considered to be a medicinal product and which is such
that the substance is liable to act upon the body with action ancillary to that of
the device.

Nebulizer chambers and systems are classed as medical devices and are within the
scope of the Medical Devices Directive 93/42/EEC including associated supplements
and amendments. Any medication supplied with the nebulizer or nebulizer system,
either prefilled or otherwise, is regulated under the Medicines Act 1968 and the
Medicines for Human Use Regulations 1994 including amendments and other
relevant EC directives.

CEP09018: October 2009


Technical considerations 7

Drug therapy intended for inhalation can be administered by nebulizer, pressurised


metered drug inhalers (MDI) or dry powder inhalers (DPI). Nebulizers allow therapy
with drugs not available with MDI or DPI and in many situations (eg ICU, A&E) are
simpler for the patient to use and allow faster drug delivery.

Aerosol particle size


An aerosol is a suspension of liquid particles or droplets that are small enough to
remain in air for a significant length of time. Nebulizers emit an aerosol containing a
distribution of particle sizes from 0.01 to 100 μm. Particles outside this range do not
have aerosol properties: they are either large enough to fall quickly or so small they
behave as air-borne molecules. The aerodynamic properties of particles depend on
their size, shape and diameter. For convenience this is often expressed as a single
measure of particle size known as mass median aerodynamic diameter (MMAD)—
half of the ‘mass’ of nebulized aerosol is contained in droplets which is larger than
the MMAD and half smaller. The geometric standard deviation (GSD) of the MMAD is
defined [1] as a dimensionless number which gives an indication of the spread of
particles that make up the aerosol; eg an aerosol with a GSD of one is made up of
particles of the same size.

Figure 1. Example cumulative particle size distribution curve

100

90
84.13
Cumulative % particle mass

80

70

60

50

40

30

20
15.87
10

0
0.1 1 1.8 4.0 8.8 10 100

Particle diameter (μm)

CEP09018: October 2009


Technical considerations 8

MMAD and GSD can be estimated from the cumulative particle size distribution curve
(figure 1):

• the size of particle at 50 % cumulative particle mass is an estimate of the


MMAD [3]. In the example curve the estimated MMAD is 4 µm
• GSD can be estimated if the particle distribution curve is linear between 10 and
90 %, ie the aerosol is log-normally distributed. The calculation is performed by
noting the particle size X at 84.13 % cumulative particle mass and the particle
size Y at 15.87 % cumulative particle mass; then GSD = √(X/Y) [3]. In the
example curve the estimated GSD is √ (8.8/1.8) = 2.2.

Other descriptors of particle size include mass median diameter (MMD) and volume
median diameter (VMD). VMD may be used as an approximation of MMD, provided
that the particle density is known not to vary with size and that the particle shape is
near spherical. Aerosol MMAD is related to MMD by the square root of the particle’s
density, ρ [5]:

MMAD = MMD √ ρ

Aerosol particle size deposition


Aerosol size expressed as MMAD can predict the site of deposition in the respiratory
tract. BS EN 13544-1 [3] provides guidance on particle deposition which should be
taken into account when choosing a nebulizer system:

• diameter > 5 μm will result in deposition in the upper airways


• diameter 2-6 μm will result in tracheobronchial deposition
• diameter 0.5-3 μm will result in alveolar deposition
• diameter < 0.5 μm are too small for deposition and are breathed out as waste.

CEP09018: October 2009


Technical considerations 9

Nebulizer types
There are three main types of nebulizer:

Jet nebulizers
These operate by forcing compressed air through a narrow restriction or venturi. As
the expanding jet of gas increases in velocity as it passes through the venturi, the
resulting decrease in pressure draws liquid up a feeder tube (Bernoulli effect), the
lower end of which is immersed in the nebulizer reservoir. Liquid leaves the upper
end of the tube and enters the air jet where it is rapidly broken up by impaction
against a strategically placed baffle plate and by air turbulence (figure 2). The
primary spray within the nebulizer contains a large range of droplet sizes, from the
very small (< 1 µm) to the very large (> 100 µm). The larger droplets fall back to the
reservoir as they impact on the interior surfaces of the nebulizer which act as baffles
filtering out all but the smallest droplets. It is this aerosol which is made available for
patient inhalation.

There are three main designs of jet nebulizer [6]:

The constant output nebulizer (described above) operates at the same rate through
the breath cycle, releasing aerosol continuously during both patient inhalation and
expiration.

Figure 2. Constant output

PATIENT PATIENT

Figure from BTS guidelines [1].

CEP09018: October 2009


Technical considerations 10

The breath-enhanced nebulizers (figure 3) allow air inhaled by the patient to be


drawn through the nebulizer, thus enhancing the rate of air and aerosol output from
the nebulizer during inhalation. Aerosol is still produced during exhalation; with
typically 30 % loss.

Figure 3. Breath-enhanced output


Inspiration Expiration

Dosimetric nebulizers (figure 4) release aerosol only to the patient during inhalation
or when a button is pressed. During exhalation, patient breath-hold or pause in
treatment, the nebulizer does not release aerosol.

Figure 4. Dosimetric output

Figures from BTS guidelines [1].

CEP09018: October 2009


Technical considerations 11

Ultrasonic nebulizers
In contrast to jet nebulizers, ultrasonic nebulizers use a high-frequency vibrating
piezo-electric crystal transducer to turn the drug solution into a mist. Conventional
ultrasound nebulizers utilise a double tank construction which requires the user to fill
the outer tank with water. The water acts as the medium that carries the vibrations
from the ultrasonic transducer to the medication tank or cup. The drug solution is
nebulized by the effect of cavitation and the resulting aerosol is carried to the
mouthpiece by airflow blown from a fan [7]. The water also acts to cool the vibrator
so that the nebulizer can run for extended periods of time.

Since they do not need an air compressor, ultrasonic nebulizers tend to be very
quiet, and do not disrupt conversations or other activities, such as listening to music
or watching television.

Figure 5. Ultrasonic nebulizer

PATIENT

Figure from Omron Healthcare Co., Ltd. [7].

CEP09018: October 2009


Technical considerations 12

Vibrating membrane or mesh nebulizers


A vibrating piezo-electric crystal transducer generates an alternating pressure field
which forces the drug solution through an array of thousands of very small apertures
in a membrane or metal-alloy mesh thus creating a fine and dense aerosol cloud [6].
Almost the entire drug volume can be nebulized into respirable droplets, thus
providing a highly efficient therapy [6]. The output rate and particle size distribution
have been optimised by manufacturers for various drug formulations and applications
by altering the membrane or mesh aperture diameters, allowing for a faster treatment
compared with conventional jet nebulizers [6].

Since vibrating mesh nebulization requires low power consumption the devices tend
to be smaller than other types of nebulizers with some portable devices operating via
batteries. As with ultrasonic nebulizers, vibrating membrane and mesh nebulizers
offer very quiet operation.

Figure 6. Vibrating mesh nebulizer

PATIENT

Figure from Omron Healthcare Co., Ltd. [7].

CEP09018: October 2009


Operational considerations 13

Table 1 is a list of nebulizer characteristics to be considered when purchasing. These


should be used in conjunction with the product information tables in the Market
review.

Table 1. Device considerations

Feature Description
We have shown the list price excluding VAT. Actual
List price (exc. VAT)
prices will be dependent on commercial factors.
This indicates that the nebulizer produces particles
with a specific size, with an intended target
deposition in the airway. This is defined in
BS EN13544-1:2007 [3] Annex BB as:
Target deposition >5 microns: upper airway, pharynx, larynx
2-6 microns: tracheobronchial
0.5-3 microns: alveoli
<0.5 microns: too small & breathed out as waste.
This indicates whether the manufacturers supplied a
particle size distribution curve either in relevant
product literature (eg user manual or specification
Particle size distribution
sheet) or when requested to do so. BS EN 13544-
1:2007 [3], clause 6.8.2 requires manufacturers to
supply a particle size distribution curve.
BS EN 13544-1:2007 [3] defines MMAD as the
MMAD (MMD) particle diameter at which 50 % of the aerosol mass
(µm) is lower and 50 % is higher and states that MMAD or
GSD can be used to define particle size.
BTS guidelines [1] define GSD as a dimensionless
number which gives an indication of the spread of
GSD particles that make up the aerosol eg an aerosol with
a GSD of one is made up of particles of the same
size.
The percentage of particles with a diameter less than
% Particles < 5 µm 5 microns. This indicates the percentage of particles
which are small enough to be deposited in the lungs.

Flow rate (and pressure) This indicates flow rate (and pressure) from a
compressed gas source (port, system or external
(l/minute) compressor).

Aerosol output BS EN 13544-1:2007 [3] defines aerosol output as


the amount of aerosol delivered by the nebulizing
(ml) system for a given filled volume.
Aerosol output rate The amount of aerosol delivered by the nebulizing
(ml/minute) system per minute.

CEP09018: October 2009


Operational considerations 14

Table 1. Device considerations (continued)

Feature Description
Respirable output The percentage of particles with diameter less than 5
(ml) microns multiplied by the aerosol output.
Nebulization time The time taken from the start of nebulization until
(minutes) cessation of continuous nebulization.
Fill volume The maximum volume of liquid which the nebulizer
(ml) chamber is designed to hold.
Residual volume The volume remaining at the end of continuous
(ml) nebulization.
The specified sound pressure level produced by a
compressor or ultrasonic / vibrating mesh nebulizer
Sound level systems. This may be important to consider if the
(dB) device is to be used in situations where noise is an
issue. Typical ambient sound level in a library is
35 dB and in an office 65 dB [8].
The conditions quoted by the manufacturer which
Specification test conditions
were used to determine the nebulizer specifications.
Any additional features offered by the devices eg
Additional features anti-spill design or the capability to nebulize at an
angle other than vertical have been listed.
These factors may be important if the device is to be
Physical size and weight
used in different clinics or at home by patients.
Devices in this guide are powered either by
compressed air if they are jet type nebulizers or by
Power
mains or batteries if they are ultrasonic or vibrating
mesh type devices.
Where applicable we have described the training or
Training
training material offered by the manufacturer.
We have listed available accessories along with their
current list prices excluding VAT. For some
Accessories (exc. VAT)
manufacturers / suppliers, prices will vary depending
on the quantity purchased.

CEP09018: October 2009


Economic considerations 15

Cost effectiveness of nebulization therapy


A full economic analysis of the cost effectiveness of nebulization therapy as a health
intervention was outside the scope of this buyers’ guide. Instead, we searched the
National Library for Health and the NHS Economic Evaluation Database (NHS EED)
for economic studies of nebulization therapy. We found two: one was a cost-
effectiveness analysis study, based in New Zealand, which compared the
administration of albuterol (salbutamol) by metered dose inhaler (MDI) and spacer
versus nebulizer in the treatment of young children with moderate to severe asthma
[9] and the other was a cost-consequence analysis which compared the
administration of tobramycin nebulizer solution (TNS) to “usual therapy” in cystic
fibrosis (CF) patients [10]. These two studies are summarised in appendix 1 table 8.

Whole-life costing
The purchase price of the device is only a fraction of the total cost of using a
nebulizer system to deliver treatment. Other costs include medication, consumables
and maintenance. The total cost of a purchase can be determined using the whole-
life costing method. For simplicity, inflation has been ignored.

Nebulizer systems
For an expected device lifetime of seven years, assuming a one-year warranty
followed by six years of maintenance, the following equation could be used to
estimate the whole life cycle cost of a nebulizer system:

Whole-life cost = P + (C × 7) + (D × N × 7) + (M × 6)

Where:

P = initial purchase price


C = reusable consumable cost per year (assuming that the medication
chamber, tubing and mouthpiece or mask only require replacement
annually)
D = cost of medication per treatment
N = number of treatments per year
M = annual maintenance cost

This applies to jet nebulizer and compressor systems, vibrating mesh nebulizers and
ultrasonic nebulizers. The initial purchasing cost is based on the list price provided by
the supplier (market review).

CEP09018: October 2009


Economic considerations 16

The main consumables that require replacement annually include the chamber and
mouthpiece or mask. For some systems, filters and tubing will also need replacing.
The cost of these varies between suppliers (market review). This costing model
assumes that all systems are mains powered. However, some systems identified in
the market review are battery powered and would incur an additional consumable
cost for batteries which will be dependent on the battery capacity, nebulization
duration and frequency of use.

A number of different diseases are treated with nebulization therapies (eg asthma,
COPD and CF), so a wide range of drug are used (table 7), whose cost is dependent
on brand and quantity administered per dose. The number of nebulization treatments
per year is affected by the management of a patient’s disease state.

Maintenance costs cover the annual servicing of the system. Maintenance may be
provided by a local hosiptal engineer or medical physics department. Otherwise the
device will need to be returned to the supplier or manufacturer at a cost (market
review).

Single patient use jet nebulizers


These are single patient use devices sold as consumables for jet nebulizer and
compressor systems or for use with a hospital ward air supply. The following
equation could be used to estimate the whole life cycle cost of a single patient use jet
nebulizer ignoring the cost of the air supply and assuming that the initial purchase
cost includes the cost of a mask or mouthpiece:

Whole-life cost = P + (D × N)

Where:

P = initial purchase price


D = cost of medication per treatment
N = number of treatments

CEP09018: October 2009


Purchasing 17

Purchasing procedures
The NHS Trust Operational Purchasing Procedures Manual provides details of the
procurement process [11].

European Union procurement rules apply to public bodies, including the NHS, for all
contracts worth more than £90,319 (from January 1st 2008) [12] (appendix 2). The
purpose of these rules is to open up the public procurement market and ensure the
free movement of goods and services within the EU. In the majority of cases, a
competition is required and decisions should be based on best value.

NHS Supply Chain (NHS SC) offers national contracts or framework agreements for
some products, goods and services. Use of these agreements is not compulsory and
NHS organisations may opt to follow local procedures.

Sustainable procurement
The UK Government launched its current strategy for sustainable development,
Securing the Future [13] in March 2005. The strategy describes four priorities in
progressing sustainable development:

• sustainable production and consumption—working towards achieving more


with less
• natural resource protection and environmental enhancement—protecting the
natural resources and habitats upon which we depend
• sustainable communities—creating places where people want to live and
work, now and in the future
• climate change and energy—confronting a significant global threat.

The strategy highlights the key role of public procurement in delivering sustainability.

This section identifies relevant sustainability issues and provides some guidance on
how these can be incorporated into procurement decision making processes.

Energy consumption
Suppliers should offer guidance on energy-efficient use of devices. Where devices
are in constant use, mains and battery energy should be included in whole-life cost
calculations.

Decontamination
Cost-effective decontamination, repair and refurbishment of the device should be
offered to extend serviceable life.

CEP09018: October 2009


Purchasing 18

End-of-life disposal
Consideration should be given to the likely financial and environmental costs of
disposal at the end of the product’s life. Where appropriate, suppliers of equipment
placed on the market after the 13th August 2005 should be able to demonstrate
compliance with the UK Waste Electrical and Electronic Equipment (WEEE)
regulations (2006) [14]. The WEEE regulations place responsibility for financing the
cost of collection and disposal on the producer. Electrical and electronic equipment is
exempt from the WEEE regulations where it is deemed to be contaminated at the
point at which the equipment is scheduled for disposal by the final user. However, if it
is subsequently decontaminated such that it no longer poses an infection risk, it is
again covered by the WEEE regulations, and there may be potential to dispose of the
unit through the normal WEEE recovery channels.

CEP09018: October 2009


Market review 19

Method
Product identification
Between August 2008 and April 2009 we carried out a review of nebulizers and
nebulizer systems on the UK market, drawing information from medical literature,
marketing literature from known suppliers, and from internet searches. We identified
69 devices from 29 UK suppliers. These comprise:

• 35 jet nebulizers chambers


• 21 jet nebulizer and compressor systems
• 6 vibrating membrane/mesh nebulizing systems
• 7 ultrasonic nebulizing systems

Collation of product information


Product information was derived from the suppliers’ or manufacturers’ product
brochures and/or from specifications published in user manuals. We have presented
this information (tables 2-5) in a common, consistent format to allow comparison
between devices. We gave suppliers an opportunity to check the accuracy of this
data prior to publication.

Evidence of performance
We searched for peer-reviewed literature relating to the performance of the
nebulizers and nebulizer systems included in the market review. The following
questions were considered:

• Have any of the nebulizers been tested to EN 13544-1 or a relevant earlier


standard, eg BS 7711-3?
• Have any of the nebulizers undergone in vitro (laboratory) testing to define
performance in terms of particle size, aerosol output and aerosol output rate?
• Have any of the nebulizers undergone in vivo (patient) testing to define
performance in terms of aerosol deposition in the lungs?

We identified relevant articles from citations in manufacturers’ and suppliers’


literature and from a search of Medline in January 2009 using two sets of search
terms:

• Makes and models of nebulizers and nebulizer systems identified in market


review
• The performance criteria of ‘particle size’, ‘aerosol output’ and ‘aerosol output
rate’.
CEP09018: October 2009
Market review 20

In addition to peer-reviewed articles, manufacturers and suppliers were asked to


provide any unpublished evidence on nebulizer performance eg test reports by
independent test houses or in-house reports by the manufacturer.

From the Medline searches, 368 articles were identified, of which 91 were relevant.
These were classified as in-vitro studies (77 articles), in vivo studies (14 articles) and
review articles (3 articles). Three articles discussed both in vitro and in vivo studies.

The in vitro and in vivo studies were reviewed along with literature supplied by the
manufacturers and summarised in tables 9-26.

CEP09018: October 2009


Market review 21

Table 2. Jet nebulizer chambers


Manufacturer: Afp Medical Supplier: Afp Medical; NHS Supply Chain;
Model: Aquineb Henleys Medical Supplies Ltd.

Nebulization rate or
2.5 ml < 4 minutes
time

Fill volume 6 ml (max.)

Residual volume 1.0 ml

£20.50 for 50 Specification test


List price (exc. VAT) EN13544-1
(£0.41 each) conditions

operates at up to 90° tilt;


Target deposition tracheobronchial Additional features
domestic compressor service
Particle size Physical size
1 information not provided 78 x 38 x 38 mm
distribution (H x W x D)
MMAD 2.47 µm Weight 13 g
GSD 2.30 Power compressed air
% Particles < 5 µm 83% Sound level < 45 dB
Flow rate provided free of charge on
9.0 l/minute @ 1.0 bar Training
(& pressure) request
adult or paediatric mouthpiece
Patient end kit £48.47 (50), £0.97 (each)
2
Aerosol output information not provided accessories
(exc. VAT) adult or paediatric mask kit
£48.47 (50), £0.97 (each)
Aquilon compressor £46.93
Aquilon Lite compressor
£44.00
Aquilon Pro compressor
£56.71
2 Accessories
Aerosol output rate 0.46 ml/minute Tourer Lite compressor
(exc. VAT)
£96.99
Ultima Lite compressor
£165.56
compressor inlet filter
£11.39 (10)
Servicing costs
Respirable output 0.38 ml/minute compressor service: £15.00
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 22

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Cardinal Health


Supplier: Cardinal Health UK Ltd.
Model: Misty Max 10

0.252 g/min @ 5 l/min*


0.325 g/min @ 8 l/min*
Nebulization rate or
time 0.329 g/min @ 10 l/min*
treatment time 8.9 mins
(average) @ 8 l/min

1.5 ml (recommended)
Fill volume
10 ml (max.)

Residual volume 0.91 g @ 5 l/min


3
using Anderson 8-stage
Specification test cascade impactor (ACI) with
List price (exc. VAT) information not provided
conditions 3ml of 0.083% albuterol
sulphate in normal saline
antispill top; one-piece snap-
Target deposition respiratory tract Additional features
in jet; crush-resistant tubing
Particle size Physical size 81 mm high x 41 mm top
1 yes
distribution (H x W x D) diameter
3
2.21 µm @ 5 l/min
3
MMAD 1.61 µm @ 8 l/min Weight 15 g
3
1.30 µm @ 10 l/min
3
2.05 @ 5 l/min
3
GSD 2.18 @ 8 l/min Power compressed air
3
2.20 @ 10 l/min
3
79.7% <4.7 µm @ 5 l/min
3
% Particles < 5 µm 85.2% <4.7 µm @ 8 l/min Sound level 62 dB
3
91.5% <4.7 µm @ 10 l/min

5 l/min @ 11 psig (min)


Flow rate 8 l/min @ 26 psig
Training information not provided
(& pressure) (recommended)
10 l/min @ 35 psig (max.)
Patient end
2 3
Aerosol output 57-2932 µl accessories information not provided
(exc. VAT)

2 3 Accessories
Aerosol output rate 57-105 µl/min information not provided
(exc. VAT)

inhaled respirable mass: Servicing costs


Respirable output 3 not applicable
383 µl @ 8 l/min (exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1
3
Data relates to ‘Specification test conditions’ information

CEP09018: October 2009


Market review 23

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Clement-Clarke
Supplier: Clement-Clarke International Limited
Model: Lifecare Micro-Neb III

Nebulization rate or 2-7.5 minutes for 2.5 ml


time (depending on compressor)

Fill volume 2-10 ml

Residual volume information not provided

Specification test
List price (exc. VAT) £0.48 each information not provided
conditions
Target deposition information not provided Additional features information not provided

Particle size Physical size


1 yes information not provided
distribution (H x W x D)

2.8-3.3 µm
MMAD Weight information not provided
(depending on compressor)

GSD information not provided Power compressed air

75.0-84.1%
% Particles < 5 µm Sound level information not provided
(depending on compressor)

Flow rate 7-10.5 litres/minute


Training information not provided
(& pressure) (depending on compressor)

Patient end
2
Aerosol output 0.36 ml @ 6.7 l/minute accessories information not provided
(exc. VAT)
Compressors:
Medix Actineb £65.00
Medix AC 2000 £135.00
2 Accessories
Aerosol output rate 0.064 ml/minute @ 6.7 l/minute Medix AC 4000 £99.00
(exc. VAT)
Medix Econoneb £115.00
Medix Turboneb £119.00
Medix World Traveller £210.00
recommend annual
Servicing costs
Respirable output information not provided compressor service via return
(exc. VAT)
to base or local agent

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 24

Table 2. Jet nebulizer chambers (continued)

Manufacturer: DeVilBiss
Supplier: DeVilBiss Healthcare
Model: Neb 800D

Nebulization rate or
3 ml in 7 minutes
time

Fill volume 2-6 ml

Residual volume <0.5 ml

Specification test 3
List price (exc. VAT) £15.45 each to BS 7711 Part 3:1994
conditions
reusable; tiltable to 45°;
Target deposition information not provided Additional features
spill-proof design
Particle size Physical size
1 yes 120.7 x 50.8 x 76.2 mm
distribution (H x W x D)
3
MMAD 3.6-4.0 µm Weight 42.5 g

GSD information not provided Power compressed air


% Particles < 5 µm 75.0% Sound level information not provided

recommended: 5.5 l/minute @


Flow rate
16 psig (range: 5.0-8.0 l/minute Training information not provided
(& pressure)
@ 14–28 psig)

Patient end
2
Aerosol output information not provided accessories information not provided
(exc. VAT)

2 3 Accessories Pulmostar compressor


Aerosol output rate 0.3 ml/min
(exc. VAT) £82.20

3 Servicing costs
Respirable output 0.12-0.20 g/min not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1
3
Data relates to ‘Specification test conditions’ information

CEP09018: October 2009


Market review 25

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Flexicare Medical Ltd.


Supplier: Flexicare Medical Ltd.
Model: MaxiNeb

Nebulization rate or
8-10 minutes
time

Fill volume 15 ml

Residual volume 1.1 ml

£23.00 for 50 Specification test


List price (exc. VAT) information not provided
(£0.46 each) conditions

anti-spill cap;
Target deposition information not provided Additional features
nebulizes up to 45°
Particle size Physical size
1 information not provided information not provided
distribution (H x W x D)
MMAD 4.18 µm Weight information not provided

GSD information not provided Power compressed air


% Particles < 5 µm 56.4% Sound level information not provided

Flow rate
5.5 l/minute Training information not provided
(& pressure)
MaxiNeb with mask
& tubing £40.00 (50)
Patient end MaxiNeb with T-piece
2
Aerosol output information not provided accessories & mouthpiece £42.50 (50)
(exc. VAT)
MaxiNeb with T-piece,
mouthpiece & tubing
£49.00 (50)
2 Accessories
Aerosol output rate 0.3 ml/minute MaxiNeb compressor £50
(exc. VAT)
Servicing costs
Respirable output 0.25 g/minute not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 26

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Hudson RCI


Supplier: Teleflex Medical
Model: Micro Mist

Nebulization rate or 0.3-0.4 ml/minute


time 6 ml in approx. 15 minutes

Fill volume 6 ml

Residual volume <1 ml

Specification test
List price (exc. VAT) £0.53 each information not provided
conditions
anti-spill chamber; nebulizes
Target deposition alveoli, bronchioles Additional features
up to 90°
Particle size Physical size
1 information not provided 75 x 40 mm (diameter)
distribution (H x W x D)
MMAD 2.7 µm Weight 18 g
GSD 3.9 Power compressed air
% Particles < 5 µm 76.3% Sound level information not provided

Flow rate 8 l/minute


Training yes, on-site
(& pressure) @ 1.24 bar (18 psi)

Micro Mist with T-piece,


tubing & connector £1.00
Micro Mist with T-piece,
mouthpiece, tubing &
connector £1.03
Micro Mist with tubing,
Patient end connector & adult mask £1.22
2
Aerosol output information not provided accessories Micro Mist with tubing,
(exc. VAT) connector & paediatric mask
£1.35
Micro Mist with in-line valve
Neb-Tee £2.75
Micro Mist with 18 mm
connector to fit in-line valve
Neb-Tee £0.59
2 Accessories
Aerosol output rate 0.3-0.35 ml/minute information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 27

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Hudson RCI


Supplier: Teleflex Medical
Model: Side Draft Neb-U-Mist

Nebulization rate or
information not provided
time

Fill volume information not provided

Residual volume information not provided

Specification test
List price (exc. VAT) information not provided information not provided
conditions
Target deposition information not provided Additional features information not provided

Particle size Physical size


1 information not provided information not provided
distribution (H x W x D)
MMAD information not provided Weight information not provided

GSD information not provided Power compressed air


% Particles < 5 µm information not provided Sound level information not provided

Flow rate
information not provided Training yes, on site
(& pressure)
Patient end
2
Aerosol output information not provided accessories information not provided
(exc. VAT)
2 Accessories
Aerosol output rate information not provided information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 28

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Hudson RCI


Supplier: Teleflex Medical
Model: Up-Draft

Nebulization rate or
0.2-0.3 ml/minute
time

Fill volume 5-15 ml

Residual volume information not provided

Specification test
List price (exc. VAT) £0.75 each information not provided
conditions
Target deposition information not provided Additional features hospital or home care use
Particle size Physical size
1 information not provided information not provided
distribution (H x W x D)
MMAD information not provided Weight information not provided

GSD information not provided Power compressed air


% Particles < 5 µm information not provided Sound level information not provided

Flow rate
7-10 l/minute Training yes, on site
(& pressure)
Patient end
2 Up-Draft with tubing & adult
Aerosol output information not provided accessories
mask £1.50
(exc. VAT)
2 Accessories
Aerosol output rate information not provided information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 29

Table 2. Jet nebulizer chambers (continued)


Manufacturer: Hudson RCI
Model: Up-Draft II, also supplied with Iso- Supplier: Teleflex Medical
Neb system
Nebulization rate or
0.2-0.3 ml/minute
time

Fill volume 8 ml

Residual volume information not provided

Specification test
List price (exc. VAT) £0.64 each information not provided
conditions
anti-spill design;
Target deposition information not provided Additional features
nebulizes up to 45°
Particle size Physical size
1 information not provided information not provided
distribution (H x W x D)
MMAD 3.50 µm Weight information not provided

GSD information not provided Power compressed air


% Particles < 5 µm information not provided Sound level information not provided

Flow rate
5-9 l/minute Training yes, on-site
(& pressure)
Up-Draft II with T-piece,
mouthpiece & tubing £1.46
Up-Draft II with T-piece,
Patient end
2 mouthpiece, reservoir tube &
Aerosol output information not provided accessories
tubing £2.50
(exc. VAT)
Up-Draft II with filtered
system, T-piece &
mouthpiece £6.07
2 Accessories
Aerosol output rate 0.2-0.3 ml/minute information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 30

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Intersurgical
Supplier: Intersurgical Ltd.
Model: Cirrus

Respirable output 0.21 g/minute

Nebulization rate or
2 ml in <10 minutes
time

Fill volume 10 ml

Residual volume 0.9 ml

working pressure: 32 psi


£42 for 75 Specification test
List price (exc. VAT) flow rate: 8 l/minute
(£0.56 each) conditions
test solution: water
Target deposition tracheobronchial (2-5 µm) Additional features information not provided

Particle size Physical size


1 yes (but not cumulative) information not provided
distribution (H x W x D)
MMAD 2.76 µm Weight 21 g
GSD information not provided Power compressed air
% Particles < 5 µm 75.0% Sound level information not provided

Flow rate
8 l/minute Training CD-ROM & DVD tutorials
(& pressure)
2 Accessories
Aerosol output 0.2 g/minute information not provided
(exc. VAT)
2 Servicing costs
Aerosol output rate information not provided not applicable
(exc. VAT)
mouthpiece £115.00 (100)
T-mouthpiece £27.00 (75)
adult mask kit with nose clip & oxygen tube £45.15 (35)
paediatric mask kit with nose clip & oxygen tube £51.60 (40)
adult mask kit with oxygen tube £44.10 (35)
paediatric mask kit with oxygen tube £50.40 (40)
Patient end
universal mouthpiece T-kit with oxygen tube £55.20 (40)
accessories
one-piece mouthpiece T-kit with oxygen tube £41.65 (35)
(exc. VAT)
anti-pollution control kit with Flextube & oxygen tube £77.00 (20)
anti-pollution control kit £110.00 (20)
22mm system T-piece kit & oxygen tube £27.00 (20)
15mm system T-piece kit & oxygen tube £42.50 (25)
10mm neonatal nebulizer bagging kit £92.00 (20)
10mm system T-piece kit & oxygen tube £43.00 (20)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 31

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Intersurgical
Supplier: Intersurgical Ltd.
Model: Cirrus 2

Nebulization rate or
2 ml in 6.5 minutes
time

Fill volume 10 ml (max.)

Residual volume 0.82 ml

£60.00 for 75 Specification test


List price (exc. VAT) information not provided
(£0.80 each) conditions

Target deposition tracheobronchial (2-5 µm) Additional features information not provided

Particle size Physical size


1 information not provided information not provided
distribution (H x W x D)
MMAD 2.70 µm Weight information not provided

GSD information not provided Power compressed air


% Particles < 5 µm 77.0% Sound level information not provided

Flow rate
8 l/minute Training CD-ROM and DVD tutorials
(& pressure)
adult eco mask kit & oxygen
tube £55.50 (30)
one-piece mouthpiece kit &
oxygen tube £59.50 (35)
universal mouthpiece T-kit
£79.20 (40)
Patient end
2 22mm breathing system T-kit
Aerosol output information not provided accessories
£79.20 (40)
(exc. VAT)
15mm breathing system T-kit
£70.00 (35)
10mm breathing system T-kit
£99.00 (45)
22mm self-sealing T-piece
£208.25 (35)
2 Accessories
Aerosol output rate 0.31 g/minute information not provided
(exc. VAT)
Servicing costs
Respirable output 0.24 g/minute not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 32

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Intersurgical
Supplier: Intersurgical Ltd.
Model: HOT Top Plus

Respirable output 0.43 g/minute

Nebulization rate or
information not provided
time

Fill volume 10 ml

Residual volume 0.9 ml

£35.75 for 65 with standard


base (£0.55 each) working pressure: 29 psi
Specification test
List price (exc. VAT) flow rate: 8 l/minute
£37.05 for 65 with Sure-Loc conditions
test solution: water
base (£0.57 each)
5ml anti-spill volume;
threaded Sure-Lock
Target deposition tracheobronchial (2-5 µm) Additional features
connector prevents tubing
from being blown off
Particle size Physical size
1 yes (but not cumulative) information not provided
distribution (H x W x D)
MMAD 3.0 µm Weight 26.79 g (with Sure-Lock)
GSD information not provided Power compressed air
% Particles < 5 µm 75.0% Sound level information not provided

Flow rate
8 l/minute Training CD-ROM & DVD tutorials
(& pressure)
2 Accessories
Aerosol output 0.57 g/minute information not provided
(exc. VAT)
2 Servicing costs
Aerosol output rate information not provided not applicable
(exc. VAT)
standard base accessories:
mouthpiece £39.00 (75)
mouthpiece kit & oxygen tube £72.90 (45)
mouthpiece kit & oxygen tube-cleanable £52.65 (45)
adult mask kit & oxygen tube £40.25 (35)
Patient end adult mask kit & oxygen tube-cleanable £21.00 (35)
accessories
paediatric mask kit & oxygen tube-cleanable £50.40 (40)
(exc. VAT)
Sure-Loc base & tube accessories:
mouthpiece kit £64.80 (45)
adult mask kit £47.25 (35)
adult mask kit with nose clip £47.25 (35)
paediatric mask kit with nose clip £54.00 (40)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 33

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Intersurgical
Supplier: Intersurgical Ltd.
Model: Micro Cirrus

Nebulization rate or
25-30 minutes
time

Fill volume 10 ml

Residual volume 1.2 ml

working pressure: 30-34 psi


£140.00 for 50 Specification test
List price (exc. VAT) flow rate: 8 l/minute
(£2.80 each) conditions
test solution: pentamidine
Target deposition alveoli (0.5-2 µm) Additional features information not provided

Particle size Physical size


1 yes (but not cumulative) information not provided
distribution (H x W x D)
MMAD 1.20 µm Weight 20 g
GSD information not provided Power compressed air
% Particles < 5 µm 96.0% Sound level information not provided

Flow rate
8 l/minute Training CD-ROM & DVD tutorials
(& pressure)
mouthpiece T-kit £85.00 (25)
Patient end anti-pollution kit with filter
2
Aerosol output information not provided accessories £83.25 (15)
(exc. VAT) eco aerosol mask neb kit
£64.75 (35)
2 Accessories
Aerosol output rate information not provided information not provided
(exc. VAT)
Servicing costs
Respirable output 0.11-0.12 g/minute not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 34

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Meditech Systems Ltd.


Supplier: Meditech Systems Ltd.
Model: Medi-Mist

1.39 ml in 10 minutes
@ 6.7 l/min
Nebulization rate or 1.37 ml in 10 minutes
time @ 7.7 l/min
1.49 ml in 10 minutes
@ 11.4 l/min

Fill volume information not provided

0.51-0.63 ml
Residual volume
depending on flow rate

Specification test using laser measurement


List price (exc. VAT) information not provided
conditions method
Target deposition information not provided Additional features information not provided

Particle size Physical size


1 information not provided information not provided
distribution (H x W x D)
MMAD information not provided Weight information not provided

GSD information not provided Power compressed air

35.0% <5.3 µm @ 6.7 l/minute


% Particles < 5 µm 43.0% <5.3 µm @ 7.7 l/minute Sound level information not provided

54.0% <5.3 µm @ 11.4 l/minute

Flow rate
information not provided Training information not provided
(& pressure)
Patient end
2
Aerosol output information not provided accessories information not provided
(exc. VAT)
2 Accessories
Aerosol output rate information not provided information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 35

Table 2. Jet nebulizer chambers (continued)

Manufacturer: PARI
Supplier: PARI Medical Ltd.
Model: LC D (disposable)

Nebulization rate or
3-6 minutes
time

Fill volume 6 ml

Residual volume information not provided

£125.00 for 50 with mask or


mouthpiece & tubing Specification test
List price (exc. VAT) 0.9% NaCl solution
conditions
(£2.50 each)
Target deposition information not provided Additional features information not provided

Particle size Physical size


1 information not provided information not provided
distribution (H x W x D)
2.0 µm @ 8 l/minute
MMAD Weight information not provided
2.5 µm @ 6 l/minute
GSD information not provided Power compressed air
84.0% @ 6 l/minute
% Particles < 5 µm Sound level information not provided
87.0% @ 8 l/minute
Flow rate
information not provided Training information not provided
(& pressure)
Patient end
2
Aerosol output information not provided accessories information not provided
(exc. VAT)

2 0.52 ml/minute @ 6 l/minute Accessories (exc.


Aerosol output rate information not provided
0.58 ml/minute @ 8 l/minute VAT)

Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 36

Table 2. Jet nebulizer chambers (continued)

Manufacturer: PARI
Supplier: PARI Medical Ltd.
Model: LC Plus

Nebulization rate or
500 mg/minute
time

Fill volume 2-8 ml

Residual volume information not provided

3 7
2.5% (3ml) or 1% (2 ml)
NaF; 0.9% NaCl (5 ml)
4
£16.64 (with valve system) using PARI Boy N or
Specification test 5
List price (exc. VAT) PARI Master
£26.72 (with filter valve set) conditions 6
compressors or
compressed air supply
@ 6l/minute
Target deposition information not provided Additional features integral valve
Particle size 3 Physical size
1 yes information not provided
distribution (H x W x D)
4
3.5 µm
5
MMAD 3.4 µm Weight information not provided
6
3.0 µm
GSD 2.10 Power compressed air
4
68.0%
5
% Particles < 5 µm 69.0% Sound level information not provided
6
73.0%
Flow rate 3.0 l/minute @ 0.5 bar (min)
Training information not provided
(& pressure) 6.0 l/minute @ 2.0 bar (max.)
filter and valve set £12.23
exhalation filter and valve
£9.03
filter pads £12.92 (30),
£38.43 (100), £260.45
7
(1000)
2 0.38 ml @ 3l/minute Patient end accessories mouthpiece without valve
Aerosol output 7
0.42 ml @ 6l/minute (exc. VAT) £1.89
tubing £0.75 to £1.50
nose clip £1.05
flap valves £1.65 or
£16.96 (12)
inspiratory valve platelets
£4.46 (10)
7
2 0.10 ml/min @ 3l/minute Accessories extension ring £1.58
Aerosol output rate 7
0.16 ml/min @ 6l/minute (exc. VAT) Y-piece £4.20
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1
3, 4, 5, 6, 7
Data relates to ‘Specification test conditions’ information
CEP09018: October 2009
Market review 37

Table 2. Jet nebulizer chambers (continued)

Manufacturer: PARI
Supplier: PARI Medical Ltd.
Model: LC Sprint
4
Nebulization rate or 500 mg/minute
time 5
590 mg/minute

Fill volume 2-8 ml

Residual volume information not provided

3 7
2.5% (3 ml) or 1% (2 ml)
NaF; 0.9% NaCl (5ml) using
£16.64 (LC Sprint with valve Specification test 4
List price (exc. VAT) PARI TurboBoy S,
system & adult mouthpiece) conditions 5 6
PARI Boy SX or PARI Boy
mobile S compressors
Target deposition information not provided Additional features integral valve
Particle size 3 Physical size
1 yes information not provided
distribution (H x W x D)
4
3.5 µm
5
MMAD 2.9 µm Weight information not provided
6
3.8 µm
GSD information not provided Power compressed air
4
68.0%
5
% Particles < 5 µm 75.0% Sound level information not provided
6
65.0%
Flow rate 3.0 l/min @ 0.5 bar (min)
Training information not provided
(& pressure) 6.0 l/min @ 2.0 bar (max.)
7
2 0.43 ml @ 3l/minute Servicing costs
Aerosol output 7 not applicable
0.45 ml @ 6l/minute (exc. VAT)
7 year pack (inc. nebulizer,
2 0.10 ml/minute @ 3 l/minute filter, mouthpiece & tubing)
Aerosol output rate 7
0.21 ml/minute @ 6 l/minute £19.74
Patient end
adult mask £1.57
accessories
4 child mask £1.57
500 mg/minute (exc. VAT)
Respirable output adult SmartMask £17.17
6
440 mg/minute mouthpiece £4.46
tubing £0.75 to £1.50
extension ring £1.58 compressor systems:
interrupter £6.77 TurboBoy S from £62.50 (NHS)
power cord £6.41 Boy mobile S £235.00 (NHS)
Accessories rechargeable battery pack £37.64, Boy SX from £64.50 (NHS)
(exc. VAT) 12V connection cable £10.97, compressor air filter £15.23 (5)
power adaptor/mains cord £13.13 compressor socket protector (price not
shoulder bag £22.05 (for Boy Mobile S) provided)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1
3, 4, 5, 6, 7
Data relates to ‘Specification test conditions’ information

CEP09018: October 2009


Market review 38

Table 2. Jet nebulizer chambers (continued)

Manufacturer: PARI
Supplier: PARI Medical Ltd.
Model: LC Sprint Baby

Nebulization rate or
150 mg/minute
time

Fill volume 2-8 ml

Residual volume information not provided

£33.76 (LC Sprint Baby sizes Specification test 0.9% NaCl (5 ml) using
List price (exc. VAT)
0, 1, 2 or 3 with mask & tubing) conditions PARI Boy SX compressor
Target deposition information not provided Additional features information not provided

Particle size Physical size


1 information not provided information not provided
distribution (H x W x D)
MMAD 2.5 µm Weight information not provided

GSD information not provided Power compressed air


% Particles < 5 µm 82.0% Sound level information not provided

Flow rate 3.0 l/minute @ 0.5 bar (min)


Training information not provided
(& pressure) 6.0 l/minute @ 2.0 bar (max.)
baby bend £3.94
Patient end baby masks sizes 0, 1, 2 or 3
2
Aerosol output information not provided accessories (with baby bend) £18.01
(exc. VAT) PARI friends (4) £5.36
tubing £0.75 to £1.50
Boy SX compressor system
2 Accessories from £64.50 (NHS)
Aerosol output rate information not provided
(exc. VAT)
carry bag £22.58
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 39

Table 2. Jet nebulizer chambers (continued)

Manufacturer: PARI
Supplier: PARI Medical Ltd.
Model: LC Sprint Junior

Nebulization rate or
320 mg/minute
time

Fill volume 2-8 ml

Residual volume information not provided

3 4
2.5 % (3ml) or 1 % (2 ml)
£18.53 (LC Spirit Junior with Specification test NaF; 0.9 % NaCl (5 ml) using
List price (exc. VAT)
mouthpiece and tubing) conditions PARI JuniorBoy S
compressor
Target deposition information not provided Additional features integral valve
Particle size 3 Physical size
1 yes information not provided
distribution (H x W x D)
MMAD 2.9 µm Weight information not provided

GSD information not provided Power compressed air


% Particles < 5 µm 76.0 % Sound level information not provided

Flow rate 3.0 l/minute @ 0.5 bar (min)


Training information not provided
(& pressure) 6.0 l/minute @ 2.0 bar (max.)
year pack (inc. nebulizer,
filter, mouthpiece & tubing)
£20.90
0.48 ml @ 3l/minute
4 Patient end baby masks sizes 0, 1, 2 or 3
2
Aerosol output 4 accessories (with baby bend) £18.01
0.49 ml @ 6l/minute (exc. VAT) child mask £1.57
mouthpiece £4.46
PARI friends (4) £5.36
tubing £0.75 to £1.50
extension ring £1.58
interrupter £6.77
JuniorBoy S compressor
0.08 ml/minute @ 3 l/minute
4 system from £68.50 (NHS)
2 Accessories (exc.
Aerosol output rate 4 power cord £6.41
0.23 ml/minute @ 6 l/minute VAT)
compressor air filter £15.23
for 5
compressor socket protector
(price not provided)
Servicing costs
Respirable output 320 mg/minute not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1
3, 4
Data relates to ‘Specification test conditions’ information

CEP09018: October 2009


Market review 40

Table 2. Jet nebulizer chambers (continued)

Manufacturer: PARI
Supplier: PARI Medical Ltd.
Model: LC Sprint Star

Nebulization rate or
450 mg/minute
time

Fill volume 2-8 ml

Residual volume information not provided

£17.69 Specification test 0.9 % NaCl (5 ml) using


List price (exc. VAT)
(LC Sprint Star with tubing) conditions PARI Boy SX compressor
peak inspiratory flow (PIF)
Target deposition information not provided Additional features
control system
Particle size Physical size
1 information not provided information not provided
distribution (H x W x D)
MMAD 2.2 µm Weight information not provided

GSD information not provided Power compressed air


% Particles < 5 µm 89.0 % Sound level information not provided

Flow rate 3.0 l/minute @ 0.5 bar (min)


Training information not provided
(& pressure) 6.0 l/minute @ 2.0 bar (max.)
Patient end mouthpiece £1.89
2
Aerosol output information not provided accessories
(exc. VAT) tubing £0.75 to £1.50

extension ring £1.58


interrupter £6.77
Boy SX compressor system
from £64.50 (NHS)
2 Accessories
Aerosol output rate information not provided power cord £6.41
(exc. VAT)
compressor air filter £15.23
for 5
compressor socket protector
(price not provided)
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 41

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Philips Respironics


Supplier: Mashco Limited
Model: Medel MedelJet Basic

2 ml in 3 minutes
Nebulization rate or
280-490 mg in first minute
time
(depending on flow rate)

Fill volume 6 ml

Residual volume 0.4 ml

Specification test
List price (exc. VAT) £3.88 each information not provided
conditions
Target deposition information not provided Additional features nebulizes up to 80°
Particle size Physical size
1 information not provided information not provided
distribution (H x W x D)
1.38-1.45 µm (API)
MMAD Weight information not provided
4.62-5.13 µm (Malvern)
GSD information not provided Power compressed air
% Particles < 5 µm information not provided Sound level information not provided

Flow rate
4-8 litres/min Training information not provided
(& pressure)
MedelJet Basic kit £5.00
MedelJet Basic kit with adult
mask £7.76
MedelJet Basic kit with
paediatric mask £5.00
Patient end MedelJet Basic kit with
2
Aerosol output information not provided accessories mouthpiece £4.00
(exc. VAT)
mouthpiece £1.75
nosepiece £1.26
adult mask £2.00
paediatric mask £2.00
universal tubing £2.00
Family Blue compressor
system £25.00
2 Accessories
Aerosol output rate information not provided Family Silver compressor
(exc. VAT)
system £27.50
compressor air filter £3.88
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 42

Table 2. Jet nebulizer chambers (continued)


Manufacturer: Philips Respironics
Model: Medel MedelJet Pro, also Microlife Supplier: Mashco Limited
NEB 50
Nebulization rate or
information not provided
time

Fill volume 2-15 ml

Residual volume 0.5 ml

Specification test
List price (exc. VAT) MedelJet Pro kit £10.00 albuterol 2.5 mg/2.5 ml
conditions
Target deposition information not provided Additional features information not provided

Particle size Physical size


1 information not provided information not provided
distribution (H x W x D)
MMAD 4.93 µm Weight information not provided

GSD information not provided Power compressed air


% Particles < 5 µm 51.3% Sound level information not provided

Flow rate
2.5-5.5 litres/minute Training information not provided
(& pressure)
MedelJet Pro with
mouthpiece £120.00 (12)
Patient end mouthpiece £2.43
2
Aerosol output information not provided accessories nosepiece £1.70
(exc. VAT) adult mask £3.40
paediatric mask £2.00
universal tubing £2.00
Pro compressor system
2 Accessories £40.00
Aerosol output rate 0.52 ml/minute
(exc. VAT) compressor air filter £3.88
compressor Porex filter £2.91
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 43

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Philips Respironics Supplier: Philips Respironics UK) Ltd.;


Model: Sidestream (reusable & disposable) NHS Supply Chain

2.5 ml in 6.7 minutes


Nebulization rate or @ 6 l/minute
time 2.5 ml in 5.4 minutes
@ 8 l/minute

Fill volume 2 ml (min.) - 10 ml (max.)

0.5-0.75 ml depending on
Residual volume
initial fill volume

Sidestream durable £14.00


Specification test
List price (exc. VAT) Sidestream disposable £56.00 information not provided
conditions
for 50 (£1.12 each)
reusable (durable) and
disposable versions;
Target deposition small airway/alveolar Additional features
compatible with System 22
accessories
Particle size Physical size
1 yes (but not cumulative) 86 x 40 x 40 mm
distribution (H x W x D)
3.00 µm @ 6 l/minute durable: 24 g
MMAD Weight
2.75 µm @ 8 l/minute disposable: 17 g
GSD information not provided Power compressed air
80.0% @ 6 l/minute
% Particles < 5 µm Sound level information not provided
85.0% @ 8 l/minute
Flow rate
6–8 l/minute Training telephone support available
(& pressure)
Portaneb Sidestream year
pack with adult mask £26.50
Patient end
2 Portaneb Sidestream year
Aerosol output information not provided accessories
pack with child mask £26.50
(exc. VAT)
Portaneb Sidestream year
pack with mouthpiece £28.00
compressor systems:
Freeway Elite Sidestream
2 Accessories
Aerosol output rate information not provided £189.00
(exc. VAT)
Portaneb Sidestream
£121.00
0.30-0.37 g/minute
@ 6 l/minute Servicing costs
Respirable output not applicable
0.39-0.46 g/minute (exc. VAT)
@ 8 l/minute

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 44

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Philips Respironics Supplier: Philips Respironics (UK) Ltd.;


Model: Ventstream NHS Supply Chain

Nebulization rate or 2.5 ml in 8-9 minutes @


time 6 l/minute

Fill volume 2 ml (min.) - 10 ml (max.)

0.5-0.75 ml depending on
Residual volume
initial fill volume

Specification test
List price (exc. VAT) Ventstream durable £26.50 information not provided
conditions
suitable for antibiotics and
Target deposition small airway/alveolar Additional features inhaled steroids; compatible
with System 22 accessories
Particle size Physical size
1 information not provided 81 x 56 x 99 mm
distribution (H x W x D)
MMAD 3.0 µm Weight 53 g
GSD information not provided Power compressed air
% Particles < 5 µm 80.0 % Sound level information not provided

Flow rate
6 l/minute Training telephone support available
(& pressure)
Patient end
2 Portaneb Ventstream year
Aerosol output information not provided accessories
pack £40.00
(exc. VAT)
compressor system:
2 Accessories
Aerosol output rate information not provided Portaneb Ventstream
(exc. VAT)
£135.00
Servicing costs
Respirable output >300 g/minute not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 45

Table 2. Jet nebulizer chambers (continued)


Manufacturer: Salter Labs
Model: 8900 Series SVN (disposable), also Supplier: Ritchie Surgical Ltd.
Tyco Healthcare Single use nebulizer
Nebulization rate or 3.0 ml in 7 minutes
time @ < 7 l/minute

Fill volume 5 ml

Residual volume information not provided

£70.00 for 50 (nebulizer only) Specification test


List price (exc. VAT) 0.9% NaCl (source @ 50 psi)
(£1.40 each) conditions

Target deposition information not provided Additional features information not provided

Particle size Physical size


1 information not provided information not provided
distribution (H x W x D)
1.3 µm @ 4 l/minute
MMAD 1.1 µm @ 6 l/minute Weight information not provided

1.0 µm @ 8 l/minute
GSD information not provided Power compressed air
98.0% @ 6 l/minute
% Particles < 5 µm Sound level information not provided
97.0% @ 8 l/minute
Flow rate
4-8 l/minute Training information not provided
(& pressure)
with adult mask & 7' supply
line £90.00 (50)
with paediatric mask & 7'
Patient end supply line £110.00 (50)
2
Aerosol output information not provided accessories with T-piece, 6" reservoir
(exc. VAT) tube & 7' supply line
£85.00 (50)
nebulizer 'in-line' kit
£85.00 (50)
2 Accessories
Aerosol output rate information not provided information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 46

Table 2. Jet nebulizer chambers (continued)


Manufacturer: Salter Labs
Model: NebuTech HDN; 8660 - reusable Supplier: Ritchie Surgical Ltd.
8960 - disposable

Respirable output information not provided

Nebulization rate or 3.0 ml in 7 minutes


time @ <7 l/minute

Fill volume 5 ml

Residual volume information not provided

Specification test
List price (exc. VAT) information not provided 0.9% NaCl (source @ 50 psi)
conditions
reusable & disposable
Target deposition information not provided Additional features
versions
Particle size Physical size
1 information not provided information not provided
distribution (H x W x D)
1.3 µm @ 4 l/minute
MMAD 1.1 µm @ 6 l/minute Weight information not provided

1.0 µm @ 8 l/minute
GSD information not provided Power compressed air
98.0% @ 6 l/minute
% Particles < 5 µm Sound level information not provided
97.0% @ 8 l/minute
Flow rate
4-10 l/min Training information not provided
(& pressure)
Salter AIRE Plus compressor
with reusable nebulizer kit
2 Accessories £50.00
Aerosol output information not provided
(exc. VAT)
(also available with other
nebulizer packs)
2 Servicing costs
Aerosol output rate information not provided not applicable
(exc. VAT)
reusable nebulizer with mouthpiece &
with adult mask & 7' supply line £220.00 (50)
7' supply line £575.00 (50)
Patient end with paediatric mask & 7' supply line
reusable mouthpiece with exhalation
accessories £230.00 (50)
valve £65.00 (50)
(exc. VAT) disposable mouthpiece with exhalation valve
disposable nebulizer with mouthpiece &
£40.00 (50)
7' supply line £197.50 (50)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 47

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Smiths Medical


Supplier: Henleys Medical UK
Model: Aerogard II Downdraft

Nebulization rate or
information not provided
time

Fill volume information not provided

Residual volume information not provided

£121.40 for 20 Specification test


List price (exc. VAT) information not provided
(£6.07 each) conditions

Target deposition information not provided Additional features spill proof


Particle size Physical size
1 yes (but not cumulative) information not provided
distribution (H x W x D)
MMAD 1.8 µm Weight information not provided

GSD information not provided Power compressed air


% Particles < 5 µm information not provided Sound level information not provided

Flow rate
information not provided Training information not provided
(& pressure)
Patient end
2
Aerosol output information not provided accessories information not provided
(exc. VAT)
2 Accessories
Aerosol output rate information not provided information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 48

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Smiths Medical


Supplier: Smiths Medical UK
Model: Mini-Neb

Nebulization rate or
information not provided
time

Fill volume information not provided

Residual volume information not provided

Specification test
List price (exc. VAT) information not provided information not provided
conditions
Target deposition information not provided Additional features spill proof
Particle size Physical size
1 information not provided information not provided
distribution (H x W x D)
MMAD information not provided Weight information not provided

GSD information not provided Power compressed air


% Particles < 5 µm information not provided Sound level information not provided

Flow rate
information not provided Training information not provided
(& pressure)
Patient end
2
Aerosol output information not provided accessories information not provided
(exc. VAT)
2 Accessories
Aerosol output rate information not provided information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 49

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Unomedical
Supplier: Unomedical Ltd.
Model: Opti-Mist Plus

Nebulization rate or
information not provided
time

Fill volume 5 ml

Residual volume information not provided

£4.88 for 10 Specification test


List price (exc. VAT) information not provided
(£0.49 each) conditions

Target deposition information not provided Additional features performs between 0-90°
Particle size Physical size
1 information not provided information not provided
distribution (H x W x D)
3.3 µm @ 6 l/minute
MMAD 1.8 µm @ 8 l/minute Weight information not provided

1.3 µm @ 10 l/minute
GSD information not provided Power compressed air
% Particles < 5 µm information not provided Sound level information not provided

Flow rate
information not provided Training information not provided
(& pressure)
nebulizer, tubing, T-piece,
mouthpiece £10.50 (10)
nebulizer, tubing, adult mask
Patient end £10.63 (10)
2
Aerosol output 2.3 ml (min) accessories
nebulizer, tubing, paediatric
(exc. VAT)
mask £12.22 (10)
mask (adult) £2.93 (10)
mask (paediatric) £4.03 (10)
2 Accessories
Aerosol output rate information not provided information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 50

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Unomedical
Supplier: Unomedical Ltd.
Model: Up-Mist

Nebulization rate or
information not provided
time

Fill volume 25 ml

Residual volume information not provided

£3.90 for 10 Specification test


List price (exc. VAT) information not provided
(£0.39 each) conditions

Target deposition information not provided Additional features information not provided

Particle size Physical size


1 information not provided information not provided
distribution (H x W x D)
MMAD 3.6 µm @ 6 l/minute Weight information not provided

GSD information not provided Power compressed air


% Particles < 5 µm information not provided Sound level information not provided

Flow rate
information not provided Training information not provided
(& pressure)
nebulizer, T-piece,
mouthpiece & tubing (2.1 m)
£8.40 (10)
nebulizer, mask & tubing
Patient end (adult) £8.50 (10)
2
Aerosol output 2.1 ml (min) accessories nebulizer, mask & tubing
(exc. VAT) (paediatric) £9.39 (10)
mouthpiece £9.85 (10)
mask (adult) £2.93 (10)
mask (paediatric) £4.03 (10)
2 Accessories
Aerosol output rate information not provided information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 51

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Vital Signs


Supplier: Vital Signs Ltd.
Model: Acorn II

Nebulization rate or
information not provided
time

Fill volume information not provided

Residual volume information not provided

nebulizer with universal supply


tube (2 m), mouthpiece, Specification test 0.9% NaCl @ 8 l/minute
List price (exc. VAT)
aerosol tube (15 cm) and conditions (50 psi)
'antidrool' tee (50) £200.00
Target deposition information not provided Additional features leak-free screw top
Particle size Physical size
1 information not provided information not provided
distribution (H x W x D)
MMAD 1.67 µm Weight information not provided

GSD information not provided Power compressed air


% Particles < 5 µm information not provided Sound level information not provided

Flow rate
information not provided Training information not provided
(& pressure)

1.9 ml/10 minutes @ 6 l/minute Patient end


2
Aerosol output accessories see list price
2.4 ml/10 minutes @ 8 l/minute (exc. VAT)
2 Accessories
Aerosol output rate 0.34 ml/minute @ 8 l/minute information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 52

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Vital Signs


Supplier: Vital Signs Ltd.
Model: Respirgard II (uses Acorn II)

Nebulization rate or
information not provided
time

Fill volume information not provided

Residual volume information not provided

Respirgard II nebulizer system


with Acorn II nebulizer, supply
tube (2m), mouthpiece, aerosol
tube (15cm), universal Specification test 0.9% NaCl @ 8 l/minute
List price (exc. VAT)
'antidrool' tee, wye, one-way conditions (50 psi)
valve and expiratory filter
£90.00 for 20 (£4.50 each) or
£200.00 for 50 (£4.00 each)
uses Acorn II nebulizer; one-
Target deposition information not provided Additional features
way valve & expiratory filter
Particle size Physical size
1 information not provided information not provided
distribution (H x W x D)
MMAD 1.67 µm Weight information not provided

GSD information not provided Power compressed air


% Particles < 5 µm information not provided Sound level information not provided

Flow rate 1.9 ml/10 minutes @ 6 l/minute


Training information not provided
(& pressure) 2.4 ml/10 minutes @ 8 l/minute
Patient end
2
Aerosol output 0.34 ml/min @ 8 l/minute accessories see list price
(exc. VAT)
2 Accessories
Aerosol output rate information not provided information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 53

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Vital Signs


Supplier: Vital Signs Ltd.
Model: Whisper Jet

Nebulization rate or
information not provided
time

Fill volume information not provided

Residual volume information not provided

Whisper Jet nebulizer with


universal oxygen supply tube
(2m), universal mouthpiece
and 'antidrool' tee £200.00 for Specification test 0.9% NaCl @ 8 l/minute
List price (exc. VAT) 50 (£4.00 each) conditions (50 psi)
As above plus 15 cm aerosol
tube £190.00 for 50 (£3.80
each)
Target deposition information not provided Additional features information not provided

Particle size Physical size


1 information not provided information not provided
distribution (H x W x D)
MMAD 1.91 µm Weight information not provided

GSD information not provided Power compressed air


% Particles < 5 µm information not provided Sound level information not provided

Flow rate
information not provided Training information not provided
(& pressure)

2.2 ml/10 minutes @ 6 l/minute Patient end


2
Aerosol output accessories see list price
3.4 ml/10 minutes @ 8 l/minute (exc. VAT)
2 Accessories
Aerosol output rate 0.24 ml/minute @ 8 l/minute information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 54

Table 2. Jet nebulizer chambers (continued)

Manufacturer: Westmed
Supplier: Intermedical UK Ltd.
Model: UniHEART

Nebulization rate or over 2 hours of nebulization


time at 2 l/minute

Fill volume 10 ml

Residual volume information not provided

Specification test
List price (exc. VAT) information not provided information not provided
conditions
Target deposition tracheobronchial (2-3 µm) Additional features information not provided

Particle size Physical size


1 information not provided information not provided
distribution (H x W x D)
MMAD information not provided Weight information not provided

GSD information not provided Power compressed air


% Particles < 5 µm information not provided Sound level information not provided

Flow rate
2-4 l/minute Training information not provided
(& pressure)
Patient end
2
Aerosol output information not provided accessories information not provided
(exc. VAT)
2 Accessories
Aerosol output rate information not provided information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 55

Table 2. Jet nebulizer chambers (continued)


Manufacturer: Westmed
Model: VixOne, also Circulaire uses VixOne Supplier: Intermedical UK Ltd.
nebulizer
Nebulization rate or
information not provided
time

Fill volume 13 ml

Residual volume 0.7 ml

Specification test
List price (exc. VAT) information not provided information not provided
conditions
anti-spill design; leak-proof;
Target deposition information not provided Additional features
angles up to 45°
Particle size Physical size
1 information not provided information not provided
distribution (H x W x D)
MMAD 2.7 µm Weight information not provided

GSD information not provided Power compressed air


% Particles < 5 µm information not provided Sound level information not provided

Flow rate
information not provided Training information not provided
(& pressure)
Patient end
2
Aerosol output information not provided accessories information not provided
(exc. VAT)
2 Accessories
Aerosol output rate information not provided information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 56

Table 3. Jet nebulizer and compressor systems

Manufacturer: Flaem Nuova


Supplier: Deva Medical Electronics Ltd.
Model: Condor 2 with RF6 basic chamber

Nebulization rate or
information not provided
time

Fill volume 2-8 ml

Residual volume information not provided

Specification test
information not provided
conditions

non-spill design; manual


List price (exc. VAT) £103.89 Additional features
nebulization control
Physical size
Target deposition information not provided 100 x 200 x 295 mm
(H x W x D)
Particle size
1 information not provided Weight 2.0 kg
distribution
MMAD 3.5 µm Power mains
GSD information not provided Battery capacity not applicable
% Particles < 5 µm 69.0% Sound level 58 dBA
Flow rate
10 l/minute Training information not provided
(& pressure)
Patient end adult mask kit £22.89
2
Aerosol output information not provided accessories
(exc. VAT) filters £9.39 (6)

2 Accessories
Aerosol output rate 0.42 ml/minute (max.) information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 57

Table 3. Jet nebulizer and compressor systems (continued)

Manufacturer: Flaem Nuova


Supplier: Cardiacare Ltd.
Model: Delphinus with RF6 Plus chamber

Nebulization rate or
information not provided
time

Fill volume 2-8 ml

Residual volume information not provided

Specification test
information not provided
conditions

non-spill design; manual


List price (exc. VAT) £55.00 Additional features
nebulization control
Physical size
Target deposition information not provided 100 x 180 x 300 mm
(H x W x D)
Particle size
1 information not provided Weight 2.1 kg
distribution
MMAD 3.2 µm Power mains
GSD information not provided Battery capacity not applicable
% Particles < 5 µm 73.0% Sound level 57 dBA
Flow rate
10 l/minute Training information not provided
(& pressure)
medication chamber £2.50
adult or child face mask
Patient end £2.00
2
Aerosol output information not provided accessories adult or child nasal prong
(exc. VAT) £1.00
mouthpiece £1.00
tubing £1.00
2 Accessories
Aerosol output rate 0.42 ml/minute (max.) air inlet filter £2.50
(exc. VAT)
Servicing costs
Respirable output information not provided information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 58

Table 3. Jet nebulizer and compressor systems (continued)

Manufacturer: Flaem Nuova (also Schill Medical) Supplier: Albert Waeschle or


Model: Nebulair Aston Clinton Scientific Ltd.

Nebulization rate or
0.54 ml/minute (max.)
time

Fill volume 2-8 ml

Residual volume approx. 1.1 ml

Specification test
information not provided
conditions

List price (exc. VAT) £84.50 Additional features information not provided

Physical size
Target deposition information not provided 100 x 200 x 305 mm
(H x W x D)
Particle size
1 information not provided Weight 2.4 kg
distribution
MMAD 2.8 µm Power mains
GSD information not provided Battery capacity not applicable
% Particles < 5 µm 76% Sound level 55 dBA
Flow rate
14 l/minute @ 1.3 bar Training none
(& pressure)
medication chamber £2.95
adult or child face mask
Patient end £2.40
2
Aerosol output information not provided accessories adult or child nasal prong
(exc. VAT) £1.20
mouthpiece £1.20
tubing £1.20
2 Accessories (exc.
Aerosol output rate 83 µl/minute information not provided
VAT)
Servicing costs
Respirable output information not provided information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 59

Table 3. Jet nebulizer and compressor systems (continued)


Manufacturer: Flaem Nuova
Supplier: Albert Waeschle or
Model: TRAVELneb with RapidFlaem 4 Cardiacare Ltd.
chamber

Nebulization rate or
0.41 mL/minute
time

Fill volume 7 ml

Residual volume information not provided

Specification test
information not provided
conditions

£139.50
List price (exc. VAT) Additional features carry bag
inc. rechargeable battery
Physical size
Target deposition information not provided 200 x 90 x 60 mm
(H x W x D)

Particle size handset 0.4 kg


1 information not provided Weight
distribution whole system 1.6 kg
mains adaptor; rechargeable
MMAD 2.75 µm Power
batteries; ext. 12V DC supply
GSD information not provided Battery capacity 30 minutes
% Particles < 5 µm 78.0% Sound level 52 dBA
Flow rate
10 l/minute @ 0.6 bar Training information not provided
(& pressure)
medication chamber £2.95
adult or child face mask
Patient end £2.40
2
Aerosol output information not provided accessories adult or child nasal prong
(exc. VAT) £1.20
mouthpiece £1.20
tubing £1.20
2 Accessories
Aerosol output rate 0.41 ml/minute air inlet filter £2.95
(exc. VAT)
Servicing costs
Respirable output information not provided information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 60

Table 3. Jet nebulizer and compressor systems (continued)


Manufacturer: MGE Medical
Model: Nivec III, also 3A Healthcare Supplier: GBUK Healthcare
HospyNeb with Fasterjet chamber

Nebulization rate or
0.8 ml/min
time

Fill volume 16 ml

Residual volume 0.7 ml

3
Specification test 4 ml 2.5% NaF
conditions 4
2 ml 1% NaF

List price (exc. VAT) information not provided Additional features continuous

Physical size
Target deposition information not provided 280 x 170 x 190 mm
(H x W x D)
Particle size
1 information not provided Weight 3.5 kg
distribution
3
3.25 µm @ 5 l/minute
MMAD 3 Power mains
2.44 µm @ 7.5 l/minute
3
2.86 @ 5 l/minute
GSD 3 Battery capacity not applicable
3.03 @ 7.5 l/minute
% Particles < 5 µm 80.0% Sound level 60 dB
7 l/minute @ 1.3 bar
Flow rate
(max. 15 l/minute Training information not provided
(& pressure)
@ 3.5 bar)

289 µl @ 5 l/minute
4 Patient end
2
Aerosol output 4 accessories information not provided
322.5 µl @ 7.5 l/minute (exc. VAT)
4
2 122.5 µl/minute Accessories
Aerosol output rate 4 information not provided
186 µl/minute (exc. VAT)

Servicing costs
Respirable output information not provided information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1
3, 4
Data relates to ‘Specification test conditions’ information

CEP09018: October 2009


Market review 61

Table 3. Jet nebulizer and compressor systems (continued)


Manufacturer: Norditalia Elettromedicali SRL
Supplier: Merlin Medical Ltd.;
Model: Arianne Power with Neboplus
Williams Medical Supplies Ltd.
ampoule chamber

Nebulization rate or open plug: 0.37 ml/minute


time closed plug: 0.12 ml/minute

Fill volume 8 ml

Residual volume 0.5 ml

3
using laser diffraction
Specification test
technique; data varies for
conditions
different solutions
nebulising chamber with two
List price (exc. VAT) £53.50 Additional features speeds; includes all patient
end accessories
Physical size
Target deposition upper and lower airways 116 x 192 x 277 mm
(H x W x D)
Particle size
1 yes Weight 2.8 kg
distribution
3
MMAD 5.00 µm @ 0.8 bar Power mains
3
GSD 2.02 @ 0.8 bar Battery capacity not applicable
3
% Particles < 5 µm 50.0% @ 0.8 bar Sound level 35 dBA
Flow rate
0.8 bar Training information not provided
(& pressure)
chamber £3.75
Patient end adult mask £1.25
2
Aerosol output 0.2 ml accessories nosepiece £1.39
(exc. VAT) mouthpiece £1.39
filter £1.96
3
open plug: 0.12 ml/minute @
2 0.8 bar Accessories
Aerosol output rate 3 information not provided
closed plug: 0.06 ml/minute @ (exc. VAT)
0.8 bar
Servicing costs
Respirable output information not provided information not provided
(exc. VAT)
1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1
3
Data relates to ‘Specification test conditions’ information

CEP09018: October 2009


Market review 62

Table 3. Jet nebulizer and compressor systems (continued)


Manufacturer: Norditalia Elettromedicali SRL
Supplier: Merlin Medical Ltd.;
Model: Drop with Neboplus ampoule
Williams Medical Supplies Ltd.
chamber

Nebulization rate or open plug: 0.37 ml/minute


time closed plug: 0.12 ml/minute

Fill volume 8 ml

Residual volume 0.5 ml

3
using laser diffraction
Specification test
technique; data varies for
conditions
different solutions
nebilizing chamber with two
List price (exc. VAT) £45.00 Additional features speeds; includes all patient
end accessories
Physical size
Target deposition upper and lower airways 170 x 145 x 190 mm
(H x W x D)
Particle size
1 yes Weight 2.0 kg
distribution

3
MMAD 5.00 µm @ 0.8 bar Power mains

3
GSD 2.02 @ 0.8 bar Battery capacity not applicable

3
% Particles < 5 µm 50.0% @ 0.8 bar Sound level 35 dBA

Flow rate
0.8 bar Training information not provided
(& pressure)
chamber £3.75
Patient end adult mask £1.25
2
Aerosol output 0.2 ml accessories nosepiece £1.39
(exc. VAT) mouthpiece £1.39
filter £1.97
Accessories
Respirable output information not provided information not provided
(exc. VAT)
3
open plug: 0.12 ml/minute @
2 0.8 bar Servicing costs
Aerosol output rate 3 information not provided
closed plug: 0.06 ml/minute (exc. VAT)
@ 0.8 bar

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1
3
Data relates to ‘Specification test conditions’ information

CEP09018: October 2009


Market review 63

Table 3. Jet nebulizer and compressor systems (continued)


Manufacturer: Norditalia Elettromedicali SRL
Supplier: Merlin Medical Ltd.;
Model: Meganeb Plus with Neboplus
Williams Medical Supplies Ltd.
ampoule chamber

Nebulization rate or open plug: 0.54 ml/minute


time closed plug: 0.22 ml/minute

Fill volume 8 ml

Residual volume 0.5 ml

3
using laser diffraction
Specification test
technique; data varies for
conditions
different solutions
nebulizing chamber with two
List price (exc. VAT) £65.00 Additional features speeds; includes all patient
end accessories
Physical size
Target deposition upper and lower airways 124 x 192 x 351 mm
(H x W x D)
Particle size
1 yes Weight 2.5 kg
distribution
3
MMAD 4.34 µm @ 1.0 bar Power mains
3
GSD 2.08 @ 1.0 bar Battery capacity not applicable
3
% Particles < 5 µm 59.0% @ 1.0 bar Sound level 30 dBA
Flow rate
1.0 bar Training information not provided
(& pressure)
chamber £3.75
Patient end adult mask £1.25
2
Aerosol output 0.26 ml accessories nosepiece £1.39
(exc. VAT) mouthpiece £1.39
filter £1.98
Accessories
Respirable output information not provided information not provided
(exc. VAT)
3
open plug: 0.14 ml/minute @
2 1.0 bar Servicing costs
Aerosol output rate 3 information not provided
closed plug: 0.07 ml/minute @ (exc. VAT)
1.0 bar

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1
3
Data relates to ‘Specification test conditions’ information

CEP09018: October 2009


Market review 64

Table 3. Jet nebulizer and compressor systems (continued)


Manufacturer: Omron Healthcare
Model: CompAir with VVT chamber (model Supplier: White Medical
NE-C28-E)
0.4 ml/minute
Nebulization rate or average 4 minutes
time 39 seconds
(2 ml saline)

Fill volume 2-7 ml

Residual volume 0.7 ml

3
Specification test 2ml 1% NaF solution
conditions to EN13544-1:2007

List price (exc. VAT) £42.00 Additional features carrying bag

Physical size
Target deposition tracheobronchial 103 x 170 x 182 mm
(H x W x D)
Particle size
1 yes Weight 1.9 kg (compressor only)
distribution
MMAD 3.0 µm Power mains
GSD 2.2 (average) Battery capacity not applicable
% Particles < 5 µm approx. 70.0% Sound level 60 dB
Flow rate
3.7 l/min @ 0.9 bar Training information not provided
(& pressure)
nebulizer VVT Nebkit £9.00
adult mask £6.00
Patient end child mask £6.00
2
Aerosol output 0.4 ml* accessories
(exc. VAT) mouthpiece £4.00
nosepiece £4.00
air tube £8.50
compressor air filters
2 3 Accessories
Aerosol output rate 0.06 ml/minute £5.00 (5)
(exc. VAT)
filter cover £4.00
Servicing costs
Respirable output average 1.60 ml (2 ml saline) information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1
3
Data relates to ‘Specification test conditions’ information

CEP09018: October 2009


Market review 65

Table 3. Jet nebulizer and compressor systems (continued)


Manufacturer: Omron Healthcare
Model: CompAir Pro with VVT chamber Supplier: White Medical
(model NE-C29-E)

0.4 ml/minute
Nebulization rate or average 4 minutes
time 57 seconds
(2 ml saline)

Fill volume 2-7 ml

Residual volume 0.7 ml

3
Specification test 2ml 1% NaF solution
conditions to EN13544-1:2007

List price (exc. VAT) £48.00 Additional features storage compartment

Physical size
Target deposition tracheobronchial 180 x 186 x 216 mm
(H x W x D)
Particle size
1 yes Weight 2.3 kg (compressor only)
distribution
MMAD 3.0 µm Power mains
GSD 2.2 (average) Battery capacity not applicable
% Particles < 5 µm approx. 70.0% Sound level 60 dB
Flow rate
3.7 l/min @ 0.9 bar Training information not provided
(& pressure)
nebulizer VVT Nebkit £9.00
adult mask £6.00
Patient end child mask £6.00
2 3
Aerosol output 0.4 ml accessories
(exc. VAT) mouthpiece £4.00
nosepiece £4.00
air tube £8.50
compressor air filters
2 3 Accessories
Aerosol output rate 0.06 ml/minute £5.00 (5)
(exc. VAT)
filter cover £4.00
Servicing costs
Respirable output average 1.58 ml (2 ml saline) information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1
3
Data relates to ‘Specification test conditions’ information

CEP09018: October 2009


Market review 66

Table 3. Jet nebulizer and compressor systems (continued)


Manufacturer: Omron Healthcare
Model: CompAir Elite with VVT chamber Supplier: White Medical
(model NE-C30-E)
0.35 ml/minute
Nebulization rate or average 6 minutes
time 55 seconds
(2 ml saline)

Fill volume 2–7 ml

Residual volume 0.7 ml

3
Specification test 2ml 1% NaF solution
conditions to EN13544-1:2007
List price (exc. VAT) £74.00 Additional features carrying bag
Physical size
Target deposition tracheobronchial 52 x 124 x 103 mm
(H x W x D)
Particle size
1 information not provided Weight 0.44 kg (compressor only)
distribution
mains adaptor or (optional)
MMAD 3.0 µm Power
rechargeable battery module
GSD information not provided Battery capacity 10 minutes x 3
% Particles < 5 µm approx. 75.0% Sound level 53 dB
Flow rate
3.0 l/minute @ 0.7 bar Training instructional DVD
(& pressure)
nebulizer VVT Nebkit £9.00
adult mask £6.00
Patient end child mask £6.00
2 3
Aerosol output 0.35 ml accessories
(exc. VAT) mouthpiece £4.00
nosepiece £4.00
air tube £8.50
compressor air filters
£5.00 (5)
2 3 Accessories filter cover £5.00
Aerosol output rate 0.05 ml/minute
(exc. VAT)
battery set £90.00
DC car adaptor lead £15.00
Servicing costs
Respirable output 1.66 ml (2 ml saline) information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1
3
Data relates to ‘Specification test conditions’ information

CEP09018: October 2009


Market review 67

Table 3. Jet nebulizer and compressor systems (continued)


Manufacturer: Omron Healthcare
Model: CompAir CX Pro with JetAIR plus Supplier: Medisave (UK) Ltd.
chamber (model NE-C18)

Nebulization rate or
0.3 ml/minute average*
time

Fill volume 6 ml

Residual volume information not provided

Specification test 3
0.9% NaCl solution
conditions

List price (exc. VAT) £53.95 Additional features integral handle; carrying bag

Physical size
Target deposition information not provided 90 x 160 x 220 mm
(H x W x D)
Particle size
1 information not provided Weight 2.0 kg
distribution
3
MMAD 3.8 µm Power mains
GSD information not provided Battery capacity not applicable
% Particles < 5 µm information not provided Sound level 60 dB
Flow rate 10 l/minute
Training information not provided
(& pressure) @ 2.5 bar (max.)

Patient end nebulizer kit £9.99


2
Aerosol output information not provided accessories mouthpiece with valve £3.67
(exc. VAT) tubing 150cm £6.82
2 Accessories compressor air filters
Aerosol output rate information not provided
(exc. VAT) £3.63 (5)
Servicing costs
Respirable output information not provided £18.50
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1
3
Data relates to ‘Specification test conditions’ information

CEP09018: October 2009


Market review 68

Table 3. Jet nebulizer and compressor systems (continued)

Manufacturer: PARI
Supplier: PARI Medical Ltd.
Model: Sole N

Nebulization rate or
information not provided
time

Fill volume 5–15 ml

Residual volume information not provided

Specification test 0.9% NaCl (5 ml) using


conditions PARI Compact compressor

£120.75 medication warming to


List price (exc. VAT) Additional features
£225.75 with compressor 36 ± 3°C for upper airways

Physical size 185 x 225 x 330 mm


Target deposition upper airways
(H x W x D) (compressor)
Particle size
1 information not provided Weight 2.7 kg
distribution
MMAD approx. 8.5 µm Power mains adaptor
GSD information not provided Battery capacity not applicable
% Particles < 5 µm 25.0% Sound level information not provided

Flow rate
3.8 l/minute @ 0.95 bar Training information not provided
(& pressure)
adult mask £1.57
child mask £1.57
Patient end adult SmartMask £17.17
2
Aerosol output information not provided accessories
(exc. VAT) mouthpiece £1.89
tracheo set £18.01
tubing £0.75 to £1.50
2 Accessories
Aerosol output rate information not provided information not provided
(exc. VAT)
Servicing costs
Respirable output approx. 1000 mg/min information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 69

Table 3. Jet nebulizer and compressor systems (continued)


Manufacturer: Philips Respironics
Model: Medel Clenny Aerosol, also Microlife Supplier: Mashco Limited
NEB 100
Nebulization rate or
information not provided
time

Fill volume 6 ml

Residual volume information not provided

Specification test
NaCl 0.9%
conditions

intermittent use: 20 min on,


List price (exc. VAT) £50.00 Additional features
40 min off; carrying bag
Physical size
Target deposition information not provided 119 x 38 x 78 mm
(H x W x D)
Particle size
1 information not provided Weight 310 g
distribution

MMAD: 1.9 or 2.1 µm mains adaptor; optional


MMAD Power rechargeable battery pack or
MMD: 4.7 µm optional 12V DC adaptor

GSD information not provided Battery capacity information not provided

% Particles < 5 µm 97.7% Sound level > 50 dBA

Flow rate
information not provided Training information not provided
(& pressure)
drug chamber £5.00
mouthpiece £1.00
Patient end nosepiece £1.00
2
Aerosol output information not provided accessories
(exc. VAT) adult mask £2.91
paediatric mask £2.00
tubing £2.55
(optional) rechargeable
2 Accessories (exc. battery pack £38.80
Aerosol output rate 0.3 ml/minute
VAT) (optional) car adaptor £10.00
(optional) ac adaptor £20.00
Servicing costs
Respirable output information not provided information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 70

Table 3. Jet nebulizer and compressor systems (continued)

Manufacturer: Philips Respironics


Supplier: Mashco Limited
Model: Medel E-Neb

Nebulization rate or
information not provided
time

Fill volume 6 ml

Residual volume information not provided

Specification test
NaCl 0.9%
conditions

£60.00 intermittent use: 20 min on,


List price (exc. VAT) Additional features
£70.00 (with battery pack) 40 min off; carrying bag
Physical size
Target deposition information not provided 40 x 90 x 105 mm
(H x W x D)

Particle size 315 g (without battery pack)


1 information not provided Weight
distribution 550 g (with battery pack)

MMAD: 1.9 or 2.1 µm mains adaptor; optional


MMAD Power rechargeable battery pack or
MMD: 4.7 µm optional 12V DC adaptor
GSD information not provided Battery capacity information not provided

% Particles < 5 µm information not provided Sound level 50 dBA


Flow rate
information not provided Training information not provided
(& pressure)
drug chamber £5.00
mouthpiece £1.00
Patient end nosepiece £1.00
2
Aerosol output information not provided accessories
(exc. VAT) adult mask £2.91
paediatric mask £2.00
tubing £2.91
rechargeable battery pack
£38.80
2 Accessories (exc. car adaptor £10.00
Aerosol output rate 0.3 ml/min
VAT)
ac adaptor £20.00
air filter £3.88
Servicing costs
Respirable output information not provided information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 71

Table 3. Jet nebulizer and compressor systems (continued)


Manufacturer: Philips Respironics
Model: Medel Family, also MPV Truma Supplier: Livingaids Ltd. or Mashco Limited
MicroDrop Family Nebulizer

Nebulization rate or
information not provided
time

Fill volume 6 ml

Residual volume information not provided

Specification test 3
NaCl 0.9%
conditions

List price (exc. VAT) £101.04 Additional features information not provided

Physical size
Target deposition information not provided 167 x 97 x 145 mm
(H x W x D)
Particle size
1 information not provided Weight 1.55 kg
distribution
4.99 µm (Malvern)
MMAD 3 Power mains
1.90 µm (API)
GSD information not provided Battery capacity not applicable
% Particles < 5 µm information not provided Sound level 55 dBA (max.)
nebulizer: 3.3 l/minute
Flow rate
compressor: 7.5 l/minute Training information not provided
(& pressure)
(max. 2.3 bar)
Patient end
2
Aerosol output information not provided accessories information not provided
(exc. VAT)
2 Accessories
Aerosol output rate 0.28 ml/min information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1
3
Data relates to ‘Specification test conditions’ information

CEP09018: October 2009


Market review 72

Table 3. Jet nebulizer and compressor systems (continued)


Manufacturer: Philips Respironics
Model: Medel Pro, also MPV Truma Supplier: Livingaids Ltd. or Mashco Limited
MicroDrop CalimeroJet & MasterVent
Professional Inhalation Systems

Nebulization rate or
information not provided
time

Fill volume 7 ml

Residual volume 0.4 ml

Specification test 3
NaCl 0.9%
conditions

valve system to reduce


waste; shoulder bag;
List price (exc. VAT) £116.71 Additional features available with animal-shaped
chamber specifically
designed for children
Physical size
Target deposition information not provided 106 x 198 x 233 mm
(H x W x D)
Particle size
1 information not provided Weight 1.91 kg
distribution
3.45 µm (Malvern)
MMAD 3 Power mains
1.93 µm (API)
GSD information not provided Battery capacity not applicable
64.00% (Malvern)
% Particles < 5 µm Sound level 52 dBA
99.93% (API)
nebulizer: 3.3 l/minute
Flow rate
compressor: 7.5 l/minute Training information not provided
(& pressure)
(max. 2.5 bar)
Patient end
2
Aerosol output information not provided accessories information not provided
(exc. VAT)
2 Accessories
Aerosol output rate 0.3 ml/minute information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1
3
Data relates to ‘Specification test conditions’ information

CEP09018: October 2009


Market review 73

Table 3. Jet nebulizer and compressor systems (continued)

Manufacturer: Philips Respironics


Supplier: Philips Respironics (UK) Ltd.
Model: MicroElite with Micro Plus chamber

Nebulization rate or
3 ml in 8 mins
time

Fill volume 6 ml

0.5-1.08 ml depending on
Residual volume
initial fill volume

Specification test
information not provided
conditions

£99.00 for kit


(includes compressor,
nebulizer, mouthpiece, tubing,
List price (exc. VAT) Additional features small portable device
filters (4), rechargeable battery,
mains adaptor, vehicle
adaptor, carry bag)
76 x 67 x 64 mm
Physical size (with battery)
Target deposition small airway/aveolar
(H x W x D) 76 x 67 x 48 mm
(without battery)

Particle size 0.450 kg (with battery)


1 information not provided Weight
distribution 0.300 kg (without battery)
mains adaptor or
MMAD 4.7 µm Power rechargeable lithium ion
polymer battery
up to 60 minutes from full 3
GSD information not provided Battery capacity hour recharge; 400 recharge
cycles
% Particles < 5 µm 54.3% Sound level 51 dBA

Flow rate 2.0 l/min @ 9.4 psi (normal) handy tips card; telephone
Training
(& pressure) 5.0 l/min @ 17.0 psi (max.) support available

1.08 ml Patient end Micro Plus nebulizer &


2
Aerosol output accessories mouthpiece £7.50; adult or
(= 640.39µg of drug delivered) (exc. VAT) paediatric mask £2.50
mains adaptor £12.00
2 0.19 g/min Accessories vehicle adaptor £10.00
Aerosol output rate
(1g = approx. 1ml (average)) (exc. VAT) rechargeable battery £25.00
compressor filters (4) £5.00
Servicing costs
Respirable output 346 µg non-serviceable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 74

Table 3. Jet nebulizer and compressor systems (continued)


Manufacturer: Schill Medical
Model: Elisir, also Flaem Nuova Elisir with Supplier: Aston Clinton Scientific Ltd.
RF6 Plus chamber

Nebulization rate or
0.42 ml/minute (max.)
time

Fill volume 2-8 ml

Residual volume approx. 1.1 ml

Specification test
information not provided
conditions

non-spill design; manual


List price (exc. VAT) £90.00 Additional features nebulization control; carrying
handle
Physical size
Target deposition lung 100 x 200 x 305 mm
(H x W x D)
Particle size
1 information not provided Weight 2.1 kg
distribution
MMAD 3.3 µm Power mains
GSD information not provided Battery capacity not applicable
% Particles < 5 µm 73% Sound level >50 dBA
10 l/minute @ 2.5 bar (max.)
Flow rate
6.2 l/minute Training none
(& pressure)
@ 0.9 bar (to nozzle)
RF5 Plus chamber £10.00
Patient end RF6 Basic chamber £10.00
2
Aerosol output information not provided accessories adult or child mask £5.00
(exc. VAT) mouthpiece £11.00
mouthpiece & filter £12.00
2 Accessories
Aerosol output rate 69 µl/minute information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 75

Table 3. Jet nebulizer and compressor systems (continued)

Manufacturer: Schill Medical


Supplier: Aston Clinton Scientific Ltd.
Model: Handy Neb

Nebulization rate or
0.33 ml/minute
time

Fill volume 7 ml

Residual volume information not provided

Specification test
information not provided
conditions

List price (exc. VAT) £140.00 Additional features information not provided

Physical size
Target deposition lung 123 x 48 x 86 mm
(H x W x D)
Particle size
1 information not provided Weight 0.35 kg (with battery)
distribution
mains, (optional)
MMAD 4.7 µm Power rechargeable battery pack or
vehicle adaptor
GSD information not provided Battery capacity approx. 30 minutes
% Particles < 5 µm 55% Sound level >50 dBA
Flow rate
2-3 l/minute @ 0.75 bar Training none
(& pressure)
Patient end
2
Aerosol output information not provided accessories information not provided
(exc. VAT)
2 Accessories
Aerosol output rate information not provided information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 76

Table 3. Jet nebulizer and compressor systems (continued)


Manufacturer: Schill Medical
Model: Master Neb, also Flaem Nuova Supplier: Aston Clinton Scientific Ltd.
Master Neb with RF6 Basic chamber

Nebulization rate or
0.32 ml/minute (max.)
time

Fill volume 2-8 ml

Residual volume approx. 1.2 ml

Specification test
information not provided
conditions

non-spill design; manual


List price (exc. VAT) £59.00 Additional features nebulization control;
accessories bag
Physical size
Target deposition lung 115 x 160 x 165 mm
(H x W x D)
Particle size
1 information not provided Weight 1.3 kg
distribution
MMAD 3.8 µm Power mains
GSD information not provided Battery capacity not applicable
% Particles < 5 µm 62% Sound level >50 dBA
9 l/minute @ 1.5 bar (max.)
Flow rate
5.1 l/minute Training none
(& pressure)
@ 0.68 bar (to nozzle)
RF5 Plus chamber £10.00
Patient end RF6 Basic chamber £10.00
2
Aerosol output information not provided accessories adult or child mask £5.00
(exc. VAT) mouthpiece £11.00
mouthpiece & filter £12.00
2 Accessories
Aerosol output rate 47 µl/min information not provided
(exc. VAT)
Servicing costs
Respirable output information not provided information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 77

Table 4. Vibrating membrane or mesh nebulizers

Manufacturer: Aerogen
Supplier: Aerogen Ltd.
Model: Aeroneb Go

Nebulization rate or
approx. 3 ml in 7.5 minutes
time

Fill volume 6 ml

Residual volume <0.1 ml for a 3 ml dose

Specification test test solution: 2 ml of 0.2%


conditions salbutamol

adult & paediatric, home use;


List price (exc. VAT) £150.00 Additional features
15 or 30 minute cycles
105 x 40 x 93 mm (nebulizer)
Physical size
Target deposition lung 32 x 70 x 110 mm (control
(H x W x D)
module)

Particle size 60 g (nebulizer)


1 yes Weight
distribution 260 g (control module)
3 x 1.5V AA batteries or
MMAD 3.6 µm (average) Power
(optional) mains adaptor
GSD 2.5 Battery capacity >3 hours
% Particles < 5 µm 65% Sound level <35 dBA at 1 metre
Flow rate
not applicable Training supplied user manuals only
(& pressure)
Patient end
2
Aerosol output 0.86 ml accessories Aeroneb Go handset £81.00
(exc. VAT)

2 >0.3 ml/minute (minimum) Accessories (exc.


Aerosol output rate information not provided
0.45 ml/minute (average) VAT)

Servicing costs
Respirable output 0.25 mg/minute not applicable
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 78

Table 4. Vibrating membrane or mesh nebulizers (continued)

Manufacturer: Aerogen
Supplier: Inspiration Healthcare Limited
Model: Aeroneb Pro

Nebulization rate or
approx. 3 ml in 7.5 minutes
time

Fill volume 10 ml

Residual volume < 0.1 ml for a 3 ml dose

Specification test test solution: 3 ml of 0.083%


conditions salbutamol

adult, paediatric or neonate,


List price (exc. VAT) information not provided Additional features hospital ventilator or clinic use
15 or 30 minute cycles
45 x 50 x 50 mm (nebulizer)
Physical size
Target deposition lung 33 x 75 x 131 mm (control
(H x W x D)
module)

Particle size 25 g (nebulizer)


1 yes Weight
distribution 230 g (control module)
NiMH rechargeable battery
MMAD 2.1 µm (average) Power
or mains adaptor

GSD 2.2 Battery capacity >45 minutes

% Particles < 5 µm 83.0% Sound level <35 dB at 0.3 metres

Flow rate
not applicable Training instruction video CD
(& pressure)
Patient end
2
Aerosol output 1.08 ml accessories information not provided
(exc. VAT)

2 >0.2 ml/min (minimum) Accessories (exc.


Aerosol output rate information not provided
0.4 ml/min (average) VAT)

Servicing costs
Respirable output 0.24 mg/minute information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 79

Table 4. Vibrating membrane or mesh nebulizers (continued)

Manufacturer: Aerogen
Supplier: Inspiration Healthcare LImited
Model: Aeroneb Solo

Nebulization rate or
approx. 3 ml in 7.5 minutes
time

Fill volume 6 ml

Residual volume <0.1 ml for 3 ml dose

Specification test test solution: 2 ml of 0.2%


conditions salbutamol

adult, paediatric or neonate,


hospital ventilator or clinic use
List price (exc. VAT) information not provided Additional features
30 minute cycle or continuous
mode
67 x 48 x 25 mm (nebulizer)
Physical size
Target deposition lung 33 x 75 x 131 mm (control
(H x W x D)
module)

Particle size 13.5 g (nebulizer)


1 information not provided Weight
distribution 230.0 g (control module)
NiMH rechargeable battery or
MMAD 3.4 µm Power
mains adaptor

GSD 2.4 Battery capacity >45 minutes

% Particles < 5 µm 65% Sound level <35 dB at 0.3 metres

Flow rate
not applicable Training information not provided
(& pressure)
Patient end
2
Aerosol output 1.02 ml accessories information not provided
(exc. VAT)

2 >0.2 ml/minute (minimum); Accessories (exc.


Aerosol output rate information not provided
0.38 ml/minute (average) VAT)

Servicing costs
Respirable output 0.3 mg/minute information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 80

Table 4. Vibrating membrane or mesh nebulizers (continued)

Manufacturer: Norditalia Elettromedicali SRL Supplier: Merlin Medical Ltd. or


Model: MO-03 Williams Medical supplies Ltd.

Nebulization rate or
information not provided
time

Fill volume 8 ml

Residual volume information not provided

Specification test
information not provided
conditions

List price (exc. VAT) £115.00 Additional features portable


Physical size
Target deposition yes information not provided
(H x W x D)
Particle size
1 information not provided Weight information not provided
distribution
mains adaptor; optional
MMAD information not provided Power
battery pack
GSD information not provided Battery capacity 45 minutes
90.0% <6 µm
% Particles < 5 µm Sound level information not provided
50.0% <2 µm
Flow rate
information not provided Training information not provided
(& pressure)
medicine cups £7.50 (10)
Patient end adult mask £3.25
2
Aerosol output information not provided accessories paediatric mask £3.75
(exc. VAT) mouthpiece £1.95
filter £1.95
2 Accessories (exc.
Aerosol output rate 1 ml/minute battery pack £55.00
VAT)
Servicing costs
Respirable output information not provided information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 81

Table 4. Vibrating membrane or mesh nebulizers (continued)


Manufacturer: Omron Healthcare
Model: MicroAir (model NE-U22V), also Supplier: White Medical
Clement-Clarke Microneb

Nebulization rate or
0.25 ml/min (min)
time

Fill volume 1–7 ml

Residual volume 0.1 ml

3
Specification test 2ml 1% NaF solution
conditions to EN13544-1:2007

continuous or manual
List price (exc. VAT) £87.00 Additional features nebulization; battery low
indicator; carry case
Physical size
Target deposition tracheobronchial 104 x 38 x 51 mm
(H x W x D)
Particle size
1 yes Weight 97 g
distribution
2 x 1.5V alkaline or
MMAD 4.2 µm Power rechargeable AA batteries;
(optional) mains adaptor
GSD 2.2 (average) Battery capacity 4 hours continuous use
% Particles < 5 µm 50.0% Sound level < 5dB
Flow rate
information not provided Training instruction video
(& pressure)
medication container £33.00
mesh cap £31.00
Patient end mask & mouthpiece adaptor
2 3
Aerosol output 0.69 ml accessories £4.50
(exc. VAT) adult mask £6.00
child mask £6.00
mouthpiece £3.00
mains adaptor £29.00
(model NE-U22VAC includes
2 3 Accessories (exc. mains adaptor)
Aerosol output rate 0.08 ml/minute
VAT) battery cover £7.50
unit cover £4.50
carry bag £10.00
Servicing costs
Respirable output average 1.93 ml (2ml saline) information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1
3
Data relates to ‘Specification test conditions’ information

CEP09018: October 2009


Market review 82

Table 4. Vibrating membrane or mesh nebulizers (continued)

Manufacturer: PARI
Supplier: PARI Medical Ltd.
Model: eFlow rapid

Respirable output information not provided

Nebulization rate or
information not provided
time

Fill volume 2–6 ml

Residual volume information not provided

Specification test 3
to EN 13544-1:2001
conditions

£495.00*
List price (exc. VAT) Additional features information not provided
(* including accessories)
63 x 50 x 145 mm (nebulizer)
Physical size
Target deposition information not provided 40 mm x 116 mm diameter
(H x W x D)
(control unit)
Particle size 3
1 yes Weight 0.3 kg (inc. batteries)
distribution
MMAD 4.1 µm Power mains or 4 x AA batteries
GSD 1.47 Battery capacity information not provided

71.3%
% Particles < 5 µm Sound level information not provided
(< 4.7 µm)
Flow rate
not applicable Training information not provided
(& pressure)
nebulizer handset £55.00
aerosol head £38.00
mouthpiece £4.25
inspiratory valve £15.00
Patient end
2 aerosol chamber &
Aerosol output 0.5 ml accessories
medication reservoir £18.00
(exc. VAT)
medication cap £7.00
nebulizer connection cord
£22.50
child SmartMask £12.55
2 Servicing costs
Aerosol output rate 0.33 ml/min information not provided
(exc. VAT)
AC power supply £40.00* battery charger £17.50
Accessories (exc. 12V adaptor £7.50 Easycare cleaning device £10.70*
VAT) carry bag £18.00* battery compartment cover £7.50
rechargeable batteries £7.00* *included

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1
3
Data relates to ‘Specification test conditions’ information

CEP09018: October 2009


Market review 83

Table 5. Ultrasonic nebulizers

Manufacturer: DeVilBiss (Kromker)


Supplier: DeVilBiss Healthcare
Model: UltraNeb

Nebulization rate or
3 ml/minute
time

Fill volume 10-50 ml

Residual volume 2 ml

Specification test
information not provided
conditions
continuous operation;
adjustable air-flow &
List price (exc. VAT) from £1044.86 Additional features
nebulization rate; timer
function; alarm functions
Physical size
Target deposition information not provided 190 x 205 x 315 mm
(H x W x D)
Particle size
1 information not provided Weight approx. 3.5 kg
distribution
MMAD <5.0 µm (average) Power mains
GSD information not provided Battery capacity not applicable
% Particles < 5 µm 86.0% Sound level 35 dBA
Flow rate
up to 20 l/minute Training full training available
(& pressure)
disposable cups and lids (12)
£26.48
disposable cups and lids (48)
£75.05
mouthpiece £1.05
Patient end
2 bacterial filter £1.24
Aerosol output information not provided accessories
(exc. VAT) sterilizable tubing (300mm)
£9.19
sterilizable tubing (1200mm)
£26.97
heatable tubing (1200mm)
£263.30

2 3 ml/minute (max.) Accessories (exc. 5 foot stand £163.83


Aerosol output rate
(2.5 ml/minute sterile water) VAT) rail clamp £43.09
Servicing costs
Respirable output information not provided £75 + parts + £12 carriage
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 84

Table 5. Ultrasonic nebulizers (continued)

Manufacturer: Omron Healthcare


Supplier: White Medical
Model: NE-U17

Nebulization rate or 0-3.8 ml/minute adjustable


time depending on medication

Fill volume 5-150 ml

Residual volume 5 ml

3
Specification test 2ml 1% NaF solution
conditions to EN13544-1:2007

large volume for medication


List price (exc. VAT) £585.00 Additional features
therapy or humidification
Physical size
Target deposition tracheobronchial 243 x 276 x 226 mm
(H x W x D)
Particle size
1 information not provided Weight approx. 4.0 kg (main unit)
distribution
MMAD 4.7 µm Power mains
GSD information not provided Battery capacity not applicable

% Particles < 5 µm approx. 50.0% Sound level <5dB


Flow rate
17 l/minute (max.) Training information not provided
(& pressure)
Patient end
2 3
Aerosol output 0-3 ml adjustable accessories medication cups £13.00 (5)
(exc. VAT)
2 3 Accessories (exc.
Aerosol output rate 0-1 ml/minute adjustable air filters £12.00 (5)
VAT)
Servicing costs
Respirable output information not provided information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1
3
Data relates to ‘Specification test conditions’ information

CEP09018: October 2009


Market review 85

Table 5. Ultrasonic nebulizers (continued)

Manufacturer: Schill Medical


Supplier: Aston Clinton Scientific Ltd.
Model: Aerosonic Combineb

Nebulization rate or
0.5 ml/minute
time

Fill volume 8 ml

Residual volume information not provided

Specification test
information not provided
conditions

interval or continuous aerosol


List price (exc. VAT) £135.00 Additional features
delivery; carrying bag
Physical size
Target deposition lung 100 x 128 x 200 mm
(H x W x D)
Particle size
1 information not provided Weight 1.1 kg
distribution
3.8 µm mains or (optional)
MMAD Power
(range 1.5-5.7 µm) rechargeable battery pack

GSD information not provided Battery capacity approx. 30 minutes


% Particles < 5 µm 68% Sound level silent
Flow rate
2-3 l/min Training none
(& pressure)
medicine cups £5.00 (5)
Patient end child or adult face mask £5.00
2
Aerosol output information not provided accessories
(exc. VAT) mouthpiece £5.00
fold tube £9.00
rechargeable battery pack
£35.00
2 Accessories (exc. aerosol heater £17.00
Aerosol output rate information not provided
VAT) nebulizer cover £5.00
air filters £5.00 (5)
Combineb cover £5.00
Servicing costs
Respirable output information not provided information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 86

Table 5. Ultrasonic nebulizers (continued)

Manufacturer: Schill Medical


Supplier: Aston Clinton Scientific Ltd.
Model: Aerosonic Mobil

Nebulization rate or
3.5 ml/minutes
time

Fill volume 8 ml

Residual volume information not provided

Specification test
information not provided
conditions

List price (exc. VAT) £149.00 Additional features information not provided

Physical size
Target deposition lung 168 x 59 x 82 mm
(H x W x D)
Particle size
1 information not provided Weight 0.26 kg
distribution
mains, (optional)
MMAD 3.8 µm Power rechargeable battery pack or
vehicle adaptor

GSD information not provided Battery capacity approx. 30 minutes

% Particles < 5 µm 68% Sound level 12 dBA

Flow rate
information not provided Training none
(& pressure)
Patient end
2
Aerosol output information not provided accessories information not provided
(exc. VAT)
rechargeable battery pack
2 Accessories (exc. £35.00
Aerosol output rate information not provided
VAT)
vehicle adaptor cable £12.00
Servicing costs
Respirable output information not provided information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 87

Table 5. Ultrasonic nebulizers (continued)

Manufacturer: Schill Medical


Supplier: Aston Clinton Scientific Ltd.
Model: Multisonic infraControl

Respirable output information not provided

Nebulization rate or
0.6 ml/minute
time

Fill volume 3-5 ml

Residual volume <1 ml

Specification test 0.9% NaCl @ a flow rate of 30


conditions l/minute
£625.00 with rechargeable
battery infrared nebulization control
List price (exc. VAT) £450.00 without rechargeable Additional features during inhalation; can also be
battery used in-line with respirators
£549.00 respirator design
Physical size
Target deposition lung alveoli 220 x 63 x 170 mm
(H x W x D)

Particle size yes


1 Weight 0.6 kg
distribution (but not cumulative)
mains adaptor or (optional)
MMAD approx. 3.5 µm Power rechargeable battery pack or 12V
vehicle adaptor
GSD 1.6 Battery capacity 1 hour
% Particles < 5 µm 70.0% Sound level <15 dBA
Flow rate
information not provided Training none
(& pressure)
power supply unit £55.00
travel set for power supply £18.00
rechargeable battery pack
2 Accessories (exc. £195.00
Aerosol output information not provided
VAT) vehicle adaptor £11.00
filter & insert £8.00
filter insert £29.00 (50)
sealing ring £12.00 (5)
2 Servicing costs
Aerosol output rate information not provided information not provided
(exc. VAT)
Patient end medication cups £15.00 (10) valve set £9.00
accessories mouthpiece £19.00 (3) valve set £37.00 (5)
(exc. VAT) impact plates £9.00 (3) monthly consumables set £75.00

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 88

Table 5. Ultrasonic nebulizers (continued)

Manufacturer: Schill Medical


Supplier: Aston Clinton Scientific Ltd.
Model: Multisonic infraControl Ventadose

Nebulization rate or 2.5 µg in 4 minutes


time 0.06 ml/minute

Fill volume 2 ml ampoules

Residual volume drug dependent

Specification test
information not provided
conditions

£695.00 inc. rechargeable specifically developed to nebulize


List price (exc. VAT) Additional features
battery Ventavis
Physical size
Target deposition lung alveoli 220 x 63 x 170 mm
(H x W x D)

Particle size yes


1 Weight 0.6 kg
distribution (but not cumulative)
mains adaptor or (optional)
MMAD approx. 3.5 µm Power rechargeable battery pack or 12V
vehicle adaptor
GSD 1.6 Battery capacity 1 hour
% Particles < 5 µm 70.0% Sound level <15 dBA
Flow rate
information not provided Training none
(& pressure)
medication cups £15.00 (10)
mouthpiece £19.00 (3)
Patient end
2 impact plates £9.00 (3)
Aerosol output information not provided accessories
valve set £9.00
(exc. VAT)
valve set £37.00 (5)
monthly consumables set £75.00
power supply unit £55.00
travel set for power supply £18.00
rechargeable battery pack
2 Accessories (exc. £195.00
Aerosol output rate information not provided
VAT) vehicle adaptor £11.00
filter & insert £8.00
filter insert £29.00 (50)
sealing ring £12.00 (5)
Servicing costs
Respirable output information not provided information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 89

Table 5. Ultrasonic nebulizers (continued)

Manufacturer: Schill Medical


Supplier: Aston Clinton Scientific Ltd.
Model: Mulisonic Profi

Nebulization rate or
0.5 ml/minute
time

Fill volume 3-5 ml

Residual volume < 1 ml

Specification test
information not provided
conditions

£350.00 (or £565.00 inc. electronic nebulization control


List price (exc. VAT) Additional features
rechargeable battery) during inhalation
Physical size
Target deposition lung alveoli 215 x 60 x 170 mm
(H x W x D)

Particle size yes


1 Weight 0.5 kg
distribution (but not cumulative)
mains adaptor or (optional)
MMAD approx. 3.5 µm Power rechargeable battery pack or
12V vehicle adaptor
GSD 1.6 Battery capacity 1 hour
% Particles < 5 µm 70.0% Sound level <15 dBA
Flow rate
information not provided Training none
(& pressure)
medication cups £15.00 (10)
mouthpiece £19.00 (3)
Patient end impact plates £9.00 (3)
2
Aerosol output information not provided accessories valve set £9.00
(exc. VAT) valve set £37.00 (5)
monthly consumables set
£75.00
power supply unit £55.00
travel set for power supply
£18.00
rechargeable battery pack
2 Accessories (exc.
Aerosol output rate information not provided £195.00
VAT)
vehicle adaptor £11.00
filter & insert £8.00
filter insert £29.00 (50)
sealing ring £12.00 (5)
Servicing costs
Respirable output information not provided information not provided
(exc. VAT)

1
Cumulative size distribution plot to EN13544-1
2
To EN13544-1

CEP09018: October 2009


Market review 90

Summary of evidence
Table 6 classifies each of the devices in the market review and indicates the levels of
evidence in support of their performance claims.

Type testing
Nebulizer manufacturers who have placed new devices for sale on the UK market
since 2001 are required to test their nebulizer systems according to the European
Standard [3]. The methods on which the European standard EN 13544-1[3] was
based were designed to reflect clinical conditions as closely as possible. The
consistency of methods to obtain this in vitro information through the European
standard [3] provides a type test of each nebulizer system.

In vitro testing provides a means of defining the performance of a nebulizer so that it


can be compared with other nebulizers, and to guide the optimal use of nebulizers in
clinical practice.

According to the standard, information and test results should be supplied with each
nebulizer and should be presented in a standardized format to include the following:

• a description of the nebulizer system which includes the flow rates and volume
fills at which tests were made
• the rate of aerosol output and the total aerosol output
• a cumulative particle size distribution curve from which the median size
(MMAD), spread (GSD) and percentage of aerosol mass within any given
range can be derived.

There are some important limitations in interpreting test data. Firstly, the standard
does not state minimum criteria for the defined measurements. Secondly, data relate
only to drug solutions that have similar properties to the Sodium Fluoride (NaF) test
solution; ie cannot be readily extended to suspensions (eg Budesonide) or solutions
that have a significantly greater viscosity than NaF (eg some antibiotics). Finally, the
rates and amounts of aerosol delivery have usually been obtained using a simulated
adult healthy breathing pattern and these cannot be readily transferred to paediatric
applications or to diseased adults.

Summary of in vitro performance testing


Seventy-seven peer-review articles and 18 unpublished reports supplied by
manufacturers described in vitro performance test results for 35 of the 69 nebulizers
identified in the market review. Eleven of the 33 devices had been tested to the
European standard, EN 13544-1 [3]. We found evidence of in vitro testing using
several different methods and drug solutions—care must be taken when using this
evidence to compare devices. Tables 9-25 in appendix 1 summarise the in vitro
evidence including methods and results.

CEP09018: October 2009


Market review 91

Summary of in vivo performance testing


In vivo performance testing is concerned with measuring the quantity and distribution
of nebulized drug reaching the lungs. We found fourteen peer-reviewed articles
describing in vivo testing relating to seven of the 69 nebulizers in the market review.
Deposition of the aerosol was measured using nuclear medicine techniques. The
results are not directly comparable as the studies used different drugs or solutions
and a variety of methods for classifying deposition. Table 26 in appendix 1
summarises the findings of each article.

Table 6. Summary of evidence


Nebulizer type Evidence type

Tested to BS EN 13544-1
Vibrating membrane or
Jet nebulizer chamber

Unpublished in-house
Peer-reviewed in vitro

Peer-reviewed in vivo
Ultrasonic nebulizer

independent testing
compressor system
Jet nebulizer and

mesh nebulizer

Unpublished

Comments
testing

testing

testing
Device

Aerogen 9 9 9 9 9
Aeroneb Go [15, 16] [17] [18, 19] [15]
Aerogen 9 9 9 9
Aeroneb Pro [20-23] [18, 19] [18, 19]
Aerogen 9 9 9
Aeroneb Solo [18, 19] [18, 19]
Afp Medical no
Aqineb 9 evidence
Cardinal 9 9 9
Health AirLife [16] [24, 25]
Misty Max 10
Clement 9 9 9 9
Clarke [26-28] [29] [29]
Lifecare
Micro-Neb III
DeVilBiss Neb no
800D 9 evidence

DeVilBiss 9 9 9
UltraNeb [30-32] [30]
Flaem Nuova 9 9 9
Condor 2 with [33-35] [34, 35]
RF6 Basic
chamber
Flaem Nuova 9 9 9
Delphinus with [33-35] [34, 35]
RF6 Plus
chamber

CEP09018: October 2009


Market review 92

Table 6. Summary of evidence (continued)


Nebulizer type Evidence type

Tested to BS EN 13544-1
Vibrating membrane or
Jet nebulizer chamber

Unpublished in-house
Peer-reviewed in vitro

Peer-reviewed in vivo
Ultrasonic nebulizer

independent testing
compressor system
Jet nebulizer and

mesh nebulizer

Unpublished

Comments
testing

testing

testing
Device
Flaem Nuova/ no
Schill Nebulair
9 evidence
Flaem Nuova
TRAVELneb
no
with 9 evidence
RapidFlaem 4
chamber
Flexicare
no
Medical Ltd 9 evidence
MaxiNeb

Hudson Micro
9 9 9
Mist [36-40] [24, 25,
41, 42]
Hudson Side
no
Draft Neb-U- 9 evidence
Mist

9 9 9
Hudson Up- [27, 28, [49, 50]
Draft 36, 43-
48]

9 9 9
Hudson Up- [27, 28, [56]
Draft II 32, 36,
37, 45,
51-57]

Intersurgical 9 9 9
Cirrus [46, 47, [42]
58, 59]
Intersurgical no
Cirrus 2 9 evidence
Intersurgical no
HOT Top Plus 9 evidence

Intersurgical 9 9
Micro Cirrus [28, 47,
59]
Meditech 9 9
Systems Ltd [60]
Medi-Mist
MGE Medical no
Nivec III 9 evidence

CEP09018: October 2009


Market review 93

Table 6. Summary of evidence (continued)


Nebulizer type Evidence type

Tested to BS EN 13544-1
Vibrating membrane or
Jet nebulizer chamber

Unpublished in-house
Peer-reviewed in vitro

Peer-reviewed in vivo
Ultrasonic nebulizer

independent testing
compressor system
Jet nebulizer and

mesh nebulizer

Unpublished

Comments
testing

testing

testing
Device

Norditalia
Arianne
Power with no
Neboplus
9 evidence
ampoule
chamber
Norditalia
Drop with
no
Neboplus 9 evidence
ampoule
chamber
Norditalia
Meganeb Plus
no
with Neboplus 9 evidence
ampoule
chamber
Norditalia no
MO-03
9 evidence
Omron
CompAir with no
VVT chamber 9 evidence
(NE-C28-E)
Omron
CompAir Pro
no
with VVT 9 evidence
chamber (NE-
C29-E)
Omron
CompAir Elite
no
with VVT 9 evidence
chamber (NE-
C30-E)
Omron
CompAir CX
Pro with no
JetAIR plus
9 evidence
chamber (NE-
C18)
Omron 9 9 9
MicroAir (NE- [22, 61- [17]
U22V) 63]
Omron NE- no
U17 9 evidence

CEP09018: October 2009


Market review 94

Table 6. Summary of evidence (continued)


Nebulizer type Evidence type

Tested to BS EN 13544-1
Vibrating membrane or
Jet nebulizer chamber

Unpublished in-house
Peer-reviewed in vitro

Peer-reviewed in vivo
Ultrasonic nebulizer

independent testing
compressor system
Jet nebulizer and

mesh nebulizer

Unpublished

Comments
testing

testing

testing
Device

PARI Medical 9 9 9 9
eFlow rapid [64, 65] [66] [67, 68]

PARI Medical 9 9 9
LC D [69] [70]
PARI Medical 9 9 9 9 9 9
LC Plus [15, 16, [66, 84] [17, 35, [67, 68] [15]
40, 47, 49, 85]
48, 53,
58, 63,
71-83]

PARI Medical 9 9
LC Sprint [67]
PARI Medical 9 9
LC Sprint [67]
Baby
PARI Medical 9 9
LC Sprint [67]
Junior

PARI Medical 9 9
LC Sprint Star [67]
no
PARI Sole N 9 evidence
Philips
Respironics no
Medel Clenny
9 evidence
Aerosol
Philips
no
Respironics 9 evidence
Medel E-Neb
Philips
no
Respironics 9 evidence
Medel Family
Philips
Respironics
no
Medel 9 evidence
MedelJet
Basic
Philips 9 9
Respironics [86]
Medel
MedelJet Pro

CEP09018: October 2009


Market review 95

Table 6. Summary of evidence (continued)


Nebulizer type Evidence type

Tested to BS EN 13544-1
Vibrating membrane or
Jet nebulizer chamber

Unpublished in-house
Peer-reviewed in vitro

Peer-reviewed in vivo
Ultrasonic nebulizer

independent testing
compressor system
Jet nebulizer and

mesh nebulizer

Unpublished

Comments
testing

testing

testing
Device
Philips
no
Respironics 9 evidence
Medel Pro
Philips
Respironics
no
MicroElite with 9 evidence
Micro Plus
chamber
Philips 9 9 9 9 9 9
Respironics [15, 27, [89] [42, 49, [85] [15]
Sidestream 28, 32, 50]
36, 39,
40, 47,
51, 52,
58, 69,
71, 72,
82, 87-
89]
Philips 9 9 9 9
Respironics [36, 47, [33, 35, [35]
Ventstream 58, 72, 49, 93]
73, 90-
92]
Salter Labs 9 9 9
8900 Series [36, 38, [24, 42,
SVN 51] 85]
Salter Labs
no
NebuTech 9 evidence
HDN
Schill
no
Aerosonic 9 evidence
Combineb
Schill
no
Aerosonic 9 evidence
Mobil
no
Schill Elisir 9 evidence
Schill Handy no
Neb 9 evidence
Schill Master no
Neb 9 evidence

CEP09018: October 2009


Market review 96

Table 6. Summary of evidence (continued)


Nebulizer type Evidence type

Tested to BS EN 13544-1
Vibrating membrane or
Jet nebulizer chamber

Unpublished in-house
Peer-reviewed in vitro

Peer-reviewed in vivo
Ultrasonic nebulizer

independent testing
compressor system
Jet nebulizer and

mesh nebulizer

Unpublished

Comments
testing

testing

testing
Device
Schill 9 9 9
Multisonic [94-96] [95]
infraControl
Schill
Mulitsonic no
infraControl 9 evidence
Ventadose
Schill 9 9
Multisonic [97]
Profi
Smiths
Medical no
Aeorgard II 9 evidence
Downdraft
Smiths 9 9 9
Medical Mini- [44, 59] [98, 99]
Neb

9
Unomedical
Opti-Mist Plus 9 [42,
100]

Unomedical 9
Up-Mist 9
[42]
Vital Signs 9 9
Acorn II [32, 37,
51, 54]
Vital Signs 9 9 9
Respirgard II [30, 46, [30,
101- 102,
104] 104-
109]
Vital Signs 9 9
Whisper Jet [36, 51,
54, 57,
88,
110]
Westmed no
UniHEART 9 evidence
Westmed 9 9 9
VixOne [36, 40, [24]
88]

CEP09018: October 2009


Market review 97

A wide range of drugs were used in the in vitro and in vivo performance testing of the
nebulizers in our market review. Table 7 lists the generic form of the drugs used and
references which devices have evidence of testing with each drug, classifying them
by the type of performance test (ie in-vitro and in vivo).

Table 7. Drugs used in the testing of nebulizers


Drug Devices with in vitro testing Devices with in vivo testing

Acetylcysteine Hudson Up-draft [48]


(NB also referred to as PARI eFlow [67]
N-acetylcsteine) PARI LC Plus [48, 83]
Amphotericin Clement Clarke Micro-Neb III [27] Vital Signs Respirgard II [104]
Hudson Up-Draft [27]
Hudson Up-Draft II [27]
Philips Respironics Sidestream [27]
Vital Signs Respirgard II [104]
Beclometasone dipropinate PARI LC Plus [82]
Philips Respironics Sidestream [82]
Vital Signs Whisper Jet [110]
Bitolterol Mesylate Hudson Up-Draft [44]
Smith Medical Mini-Neb [44]
Budesonide PARI LC Plus [40, 67, 73, 82, 83, 85]
PARI LC Sprint [67]
Philips Respironics Medel MedelJet Pro [86]
Philips Respironics Sidestream [82, 85]
Philips Respironics Ventstream [73, 93]
Salter 8900 [85]
Westmed VixOne [40]
Ceftazidime Aerogen Aeroneb Pro [23]
DeVilBiss Ultraneb [32]
Hudson Up-Draft II [32]
Vital Signs Acorn II [32]
Ciprofloxacin Clement Clarke Micro-Neb III [26]
DeVilBiss Ultraneb [32]
Hudson Up-Draft II [32]
Philips Respironics Sidestream [32]
Vital Signs Acorn II [32]
Colistimethate sodium Clement Clarke Micro-Neb III [26, 27]
(NB also referred to as DeVilBiss Ultraneb [32]
Colomycin®) Hudson Up-Draft [27, 49]
Hudson Up-Draft II [27, 32]
PARI eFlow [67]
PARI LC Plus [48, 49]
Philips Respironics Sidestream [27, 32, 49]
Philips Respironics Ventstream [49]
Vital Signs Acorn II [32]
Colistin Hudson Up-Draft II [55]

CEP09018: October 2009


Market review 98

Table 7. Drugs used in the testing of nebulizers (continued)


Drug Devices with in vitro testing Devices with in vivo testing

Dornase Alfa (rhDNase) Hudson Up-Draft [50]


Hudson Up-Draft II [52]
Omron MicroAir [63]
PARI eFlow [67]
PARI LC Plus [63]
Philips Respironics Sidestream [50, 52]
Ethanol Aerogen Aeroneb Pro [22]
Omron MicroAir [22]
Flunisolide Hudson Up-Draft [48]
PARI LC Plus [48, 82]
Philips Respironics Sidestream [82]
Fluticasone propionate PARI LC Plus [82]
Philips Respironics Sidestream [82]
Formoterol PARI LC Plus [83]
Gentamicin Clement Clarke Micro-Neb III [26, 27]
DeVilBiss Ultraneb [32]
Hudson Micro Mist [37]
Hudson Up-Draft [27]
Hudson Up-Draft II [27, 32, 37]
Philips Respironics Sidestream [27, 32]
Vital Signs Acorn II [32, 37]
Glycerol Aerogen Aeroneb Pro [22]
Omeron MicroAir [22]
Heparin calicum Philips Respironics Sidestream [87]
Heparin sodium Philips Respironics Sidestream [87]
Iloprost Schill Multisonic infraControl [95]
(NB referred to as Ventavis®)
Ipratopium bromide Hudson Up-Draft [48]
PARI eFlow [67]
PARI LC Plus [48, 67, 81, 83, 85]
PARI LC Sprint [67]
PARI LC Sprint Baby [67]
PARI LC Sprint Junior [67]
PARI LC Sprint Star [67]
Philips Respironics Medel MedelJet Pro [86]
Philips Respironics Sidestream [81, 85]
Salter 8900 [85]
Liposomal amikacin PARI eFlow [65]
Methylprednisolone DeVilBiss Ultraneb [30] DeVilBiss Ultraneb 99 [30]
Vital Signs Respirgard II [30] Vital Signs Respirgard II [30]
Pentamidine isethoinate Vital Signs Respirgard II [101-103] Vital Signs Respirgard II [102, 105-107, 109]
Perflurocarbons PARI LC Plus [79]

CEP09018: October 2009


Market review 99

Table 7. Drugs used in the testing of nebulizers (continued)


Drug Devices with in vitro testing Devices with in vivo testing

Epoprostenol Hudson Up-Draft II [57]


(NB also known as Vital Signs Whisper Jet [57]
Prostacyclin)
Salbutamol sulphate Aerogen Aeroneb Go [16, 17]
(NB also known as Albuterol) Aerogen Aeroneb Pro [21]
Cardinal Health Misty Max [16, 24, 25]
Hudson Micro Mist [24, 25, 36-38, 40]
Hudson Up-Draft [36, 45, 46, 48]
Hudson Up-Draft II [36, 37, 45, 51, 54]
Intersurgical Cirrus [46, 72, 111]
Omron MicroAir [17, 61, 62]
PARI LC D [69]
PARI LC Plus [16, 17, 40, 48, 67, 80, 85]
PARI LC Sprint [67]
PARI LC Sprint Baby [67]
PARI LC Sprint Junior [67]
PARI LC Sprint Star [67]
Philips Respironics Medel MedelJet Pro [86]
Philips Respironics Sidestream [36, 40, 51,
69, 72, 85, 88]
Philips Respironics Ventstream [36, 72, 90]
Salter 8900 [24, 36, 38, 51, 85]
Vital Signs Acorn II [37, 51, 54]
Vital Signs Respirgard II [46]
Vital Signs Whisper Jet [36, 51, 54, 88]
Westmed VixOne [24, 36, 40, 88]
Sildenafil Hudson Up-Draft II [57]
Vital Signs Whisper Jet [57]
Sodium chloride Aerogen Aeroneb Pro [22] PARI LC Plus [84]
(NB also referred to as Clement Clarke Micro-Neb III [28] Smiths Medical Mini-Neb [98, 99]
Saline) DeVilBiss Ultraneb [32] Vital Signs Respirgard II [108]
Hudson Micro Mist [39, 41]
Hudson Up-Draft [28, 43]
Hudson Up-Draft II [28, 32, 54]
Intersurgical Micro cirrus [28]
Omron MicroAir [22]
PARI eFlow [67]
PARI LC Plus [72, 77]
Philips Respironics Sidestream [28, 32, 39]
Schill Multisonic Profi [97]
Unomedical Opti-Mist Plus [42, 100]
Unomedical Up-Mist [42]
Vital Signs Acorn II [32, 54]
Vital Signs Whisper Jet [54]

CEP09018: October 2009


Market review 100

Table 7. Drugs used in the testing of nebulizers (continued)


Drug Devices with in vitro testing Devices with in vivo testing

Sodium cromoglicate Hudson Micro Mist [37]


(NB also referred to as Hudson Up-Draft [48]
Cromolyn and Disodium Hudson Up-Draft II [37, 56]
cromoglycate)
PARI LC Plus [67, 83]
PARI LC Sprint [67]
PARI LC Sprint Baby [67]
PARI LC Sprint Junior [67]
PARI LC Sprint Star [67]
Philips Respironics Medel MedelJet Pro [86]
Schill Multisonic Profi [97]
Vital Signs Acorn II [37]
Sodium fluoride Aerogen Aeroneb Go [15, 18, 19]
Aerogen Aeroneb Pro [18, 19]
Aerogen Aeroneb Solo [18, 19]
Clement Clark Micro-Neb III [29]
Flaem Nuova RF6 Basic [33, 35]
Flaem Nuova RF6 Plus [33, 35]
Hudson Up-draft II [56]
Intersurgical Cirrus [58]
Omron MicroAir [62]
PARI LC Plus [15, 35, 58, 75]
Philips Respironics Sidestream [15, 32, 47,
58]
Philips Respironics Ventstream [33, 35, 58]
Sterile water Intersurgical Cirrus [59]
Intersurgical Micro cirrus [59]
Smith Medical Mini-Neb [59]
Tezosentan Hudson Up-draft II [57]
Vital Signs Whisper Jet [57]
Tinzaparin sodium Philips Respironics Sidestream [87]
Tobramycin Aerogen Aeroneb Pro [20] PARI eFlow [66]
Clement Clarke Micro-Neb III [27] PARI LC Plus [66]
DeVilBiss Ultraneb [31, 32]
Hudson Micro Mist [37]
Hudson Up-Draft [27, 47, 48]
Hudson Up-Draft II [27, 32, 37, 53, 54]
Intersurgical Cirrus [47]
Intersurgical Micro cirrus [47]
PARI eFlow [67, 68]
PARI LC Plus [47, 48, 53, 68, 74, 76-78]
Philips Respironics Sidestream [27]
Philips Respironics Venstream [47]
Vital Signs Acorn II [32, 37, 54]
Vital Signs Whisper Jet [54]

CEP09018: October 2009


Market review 101

Choosing a nebulizer
We found evidence of significantly different performance between currently available
nebulizer systems. Overall system performance depends on the intended use. For
example, if a system was required to deliver the maximum amount of aerosol
droplets in the respirable range (ie < 5 µm) in the minimum amount of time, then the
characteristics of a good system would include the following:

• a fast rate of nebulization, implying that a maximum amount of nebulized


aerosol would be available to the patient over any given time
• a minimum amount of waste of the drug aerosol, implying that the maximum
amount of aerosol released would be delivered to the patient and not emitted
into the environment
• a low residual volume, implying that more of the fill volume would be delivered
to the patient as aerosol.

If the same system was required to deliver a relatively small volume of drug aerosol,
then the one described above may be unsuitable because such an efficient system of
delivery will deliver an unnecessarily large aerosol dose with possible increased local
and systemic side-effects.

Consideration must be given to matching nebulized drug delivery to the performance


of the nebulizer systems. This may vary according to the needs of different patient
groups or stages of disease. The two main factors to take into account are:

• how much nebulized drug is ideally required for delivery to the patient
• what is the aerosol size required to deliver nebulized droplets to the target site
in the airway (small aerosols, ~0.5 µm, will deposit peripherally, whereas
larger droplets, ~5 µm, will mainly be deposited more centrally)?

The ERS guidelines [2] state that there is little clinical evidence to answer these
questions, recognising that it is difficult to choose the ideal nebulizer system for a
given application. The guidelines [2] recommend that a scheme is developed to
define the best available nebulizer system for various therapies, in order to reduce
variability in nebulized dose delivery and thereby improve clinical practice.

CEP09018: October 2009


Acknowledgements 102

We should like to thank the following for their contribution to this buyers’ guide:

Manufacturers and suppliers.

Sister Karen Heslop, Respiratory Medicine, Royal Victoria Informary, Newcastle upon
Tyne Hospitals NHS Foundation Trust.

CEP09018: October 2009


Glossary 103

Aerosol
A suspension of particles in gas.

Aerosol output
Amount of aerosol delivered by the nebulizing system for a given filled volume.

Aerosol output rate


Amount of aerosol delivered by the nebulizing system per unit of time.

DPI
Dry powder inhaler.

GSD
Geometric standard deviation.

MDI
Metered dose inhaler.

MMD
Mass median diameter.

MMAD
Mass median aerodynamic diameter.

Nebulizer
A device which converts liquid into a gas.

Nebulizing system
A device, including all parts, required to convert a liquid into an aerosol and make it
available for inhalation.

Type test
A test to determine whether a device meets a specific standard.

VMD
Volume median diameter

CEP09018: October 2009


References 104

1.Muers M, Ahmedzai S, Barry P, Brewin A, Conway S, Currie D, Davis C,


Kendrick A, Miller R, O'Callaghan C, Dodd M, O'Doherty M, O'Driscoll B,
Pounsford J, Smith E, Spencer D, Thomas S, Ward M, Watson A, Webb A and
Wilson R. British Thoracic Society Guidelines: Nebulizer treatment best
practice guidelines. Thorax 1997 52(Suppl. 2):S1-S106.

2. Boe J, Dennis J, O'Driscoll B, Bauer T, Carone M, Dautzenburg P, Diot P,


Heslop K and Lannefers L. Guidelines prepared by a European Respiratory
Society Task Force on the use of nebulizers. Eur Respir J 2001 18:228-42.

3. BSI. BS EN 13544-1: 2007 Respiratory therapy equipment - Part 1: Nebulizing


systems and their components.

4. MHRA. Bulletin No. 17 Medical Devices and Medicinal Products, 2009.

5. Encyclopedia of Pharmaceutical Technology. Swarbrick J and Boylan J


(Eds.). New York: Marcel Dekker, 2001.

6. Practical Handbook of Nebulizer Therapy. Boe J, O'Driscoll B and Dennis J


(Eds.). London: Martin Dunitz, 2004.

7. Omron. Talking about nebulization method.


www.healthcare.omron.co.jp/english/neu_method.html, 2009.

8. Brüel and Kjær. Measuring Sound. Denmark: Brüel and Kjær, 1984.

9. Leversha A, Campanella S, Aickin R and Asher M. Costs and effectiveness of


spacer versus nebuliser in young children with moderate and severe acute
asthma. NHS EED 2002.

10. Iles R, Leigh-Smith J, Drummond M, Prevost A and Vowler S. Economic


evaluation of tobramycin nebuliser solution in cystic fibrosis. NHS EED 2005.

11. NHS trust operational purchasing procedures manual - TOPPM.


http://nww.pasa.nhs.uk/PASAWeb/Guidance/TOPPM/LandingPage.htm, 2008.

12. EU Procurement Thresholds.


http://www.ogc.gov.uk/procurement_policy_and_application_of_eu_rules_eu_
procurement_thresholds_.asp, 2008.

CEP09018: October 2009


References 105

13. UK Government sustainable development strategy.


http://www.defra.gov.uk/sustainable/government/publications/index.htm, 2009.

14. The Waste Electrical and Electronic Equipment Regulations.


http://www.berr.gov.uk/files/file35992.pdf, 2006.

15. Majoral C, Le Pape A, Diot P and Vecellio L. Comparison of Various Methods


for Processing Cascade Impactor Data. Aerosol Sci Technol 2006 40:672-82.

16. Dennis J, Berg E, Sandell D, Ali A, Lamb P, Tservistas M, Karlsson M and


Mitchell J. Cooling the NGI - an approach to size a nebulised aerosol more
accurately. Pharmeur Sci Notes 2008 1:27-30.

17. Simmons R, Kakade P, Uster P and Fink J. In vitro comparison of an


electronic micropump nebulizer with other high effciency nebulizers, 2008.

18. Behan N, MacLoughlin R and Duffy C. Cascade Impactor method for


determination of MMAD, 2009.

19. MacLoughlin R, Behan N and Duffy C. Nebuliser Performance Testing


Protocol, 2009.

20. Pedersen K, Handlos V, Heslet L and Kristensen H. Factors influencing the in


vitro deposition of tobramycin aerosol: a comparision of an ultrasonic nebulizer
and a high-frequency vibrating mesh nebulizer. J Aerosol Med 2006
19(2):175-83.

21. Fink J. New technology offers new opportunities: Continuous bronchodilator


therapy during mechanical ventilation. Respir Ther 2007 2(4):29-32.

22. Ghazanfari T, Elhissi A, Ding Z and Taylor K. The influence of fluid


physicochemical properties on vibrating-mesh nebulization. Int J Pharm 2007
339(1-2):103-11.

23. Ferrari F, Liu Z, Lu Q, Becquemin M, Louchahi K, Aymard G, Marquette C and


Rouby J. Comparison of lung tissue concentrations of nebulized ceftazidime in
ventilated piglets: ultasonic versus vibrating plate nebulizers. Intensive Care
Med 2008 34(9):1718-23.

24. Rivera D. Medication Delivery: Misty Max 10 Performance. Cardinal Health.


2004.

CEP09018: October 2009


References 106

25. Cardinal Health. Inhaled respirable mass performance over time. Cardinal
Health. 2004.

26. Hung J, Hambleton G and Super M. Evaluation of two commerical jet


nebulisers and three compressors for the nebulisation of antibiotics. Arch Dis
Child 1994 71:335-8.

27. Hurley P, Smye S and Cunliffe H. Assessment of antibiotic aerosol generation


using commerical jet nebulizers. J Aerosol Med 1994 7(3):217-28.

28. Hurley P and Smye S. Performance assessment of a range of commerical jet


nebulisers. Technolo Health Care 1994 1:209-14.

29. Clement Clarke International. Nebuliser System (Nebular and Lifecare


Microneb III). Clement Clarke International.

30. Véra P, Blot F, Gambini D, Becquemin M, Dumas F, Beyne P, Caubarrere I


and Barritault L. Comparision of jet and ultrasonic nebulizers for alveolar
targeting of methylprednisolone. Nucl Med Commun 1995 16(5):344-8.

31. O'Riordan T and Amram J. Effect of nebulizer configuration on delivery of


aerosoized tobramycin. J Aerosol Med 1997 10(1):13-23.

32. Weber A, Morlin G, Cohen M, Williams-Warren J, Ramsey B and Smith A.


Effect of nebulizer type and antibotic concentration on device performance.
Pediatr Pulmonol 1997 23(4):249-60.

33. Flaem Nuova. The effectiveness of the aerosol therapy with the nebulizers of
Flaem Nuova SpA.
http://www.multisonic.de/englisch/studien/studies_en/02_droplet%20size/2-
2%20Output%20and%20MMAD%20of%20FLAEM%20Jet%20nebulizers%20i
n%20comparison%20Inamed%202004.pdf, 2004.

34. TÜV Rheinland Product Safety GmbH. Test Report: 21110780_003:


EN13544-1:2001, Particle size and output. Inamed GmbH. 2004.

35. TÜV Rheinland Product Safety GmbH. Test Report 21110780_004: EN13544-
1:2001, Particle size and output. Inamed GmbH. 2004.

36. Hess D, Fisher D, Williams P, Pooler S and Kacmarek R. Medication nebulizer


performance. Effects of diluent volume, nebulizer flow, and nebulizer brand.
Chest 1996 110(2):498-505.
CEP09018: October 2009
References 107

37. Standaert T, Morlin G, Williams-Warren J, Joy P, Pepe M, Weber A and


Ramsey B. Effects of repetitive use and cleaning techniques of disposable jet
nebulizers on aerosol generation. Chest 1998 114(2):577-86.

38. Reisner C, Katial R, Bartelson B, Buchmeir A, Rosenwasser L and Nelson H.


Characterization of aerosol output from various nebulizer/compressor
combinations. Ann Allergy Asthma Immunol 2001 86(5):566-74.

39. Wong-Beringer A, Lambros M, Beringer P and Johnson D. Suitability of


caspofungin for aerosol delivery: physicochemical profiling and nebulizer
choice. Chest 2005 128(5):3711-6.

40. Zhou Y, Ahuja A, Irvin C, Kracko D, McDonald J and Cheng Y. Medical


nebulizer performance: effects of cascade impactor temperature. Respir Care
2005 50(8):1077-82.

41. Piper S. Cascade Impactor Particle Size Evaluation of Hudson Micromist with
22 mm cap. Piper Medical Products. 2002.

42. Nelson Laboratories. Nebulizer characterization study (Protocol No


200508001-02; Laboratory No 287091). Nelson Laboratories. 2005.

43. Sterk P, Plomp A, van de Vate J and Quanjer P. Physical properties of


aerosols produced by several jet- and ultrasonic nebulizers. Bull Eur
Physiopathol Respir 1984 20(1):65-72.

44. Hunke W and Yu A. Particle-size distribution of bitolterol mesylate solution


delivered by four compressed-air nebulizer devices. Am J Hosp Pharm 1987
44(6):1392-6.

45. MacNeish C, Meisner D, Thilbert R, Kelemen S, Vadas E and Coates A. A


comparison of pulmonary availability between Ventolin (albuterol) nebules and
Ventolin (albuterol) Respirator Solution. Chest 1997 111(1):204-8.

46. Tandon R, McPerk M and Smaldone G. Measuring nebulizer output. Aerosol


production vs gravimetric analysis. Chest 1997 111(5):1361-5.

47. Le Brun P, de Boer A, Gjaltema D, Hagedoorn P, Heijerman H and Frijlink H.


Inhalation of tobramycin in cystic fibrosis. Part 1: the choice of a nebulizer. Int
J Pharm 1999 189(2):205-14.

CEP09018: October 2009


References 108

48. Berliniski A and Waldrep J. Nebulized drug admixtures: effect on aerosol


characteristics and albuterol output. J Aerosol Med 2006 19(4):484-90.

49. Geller D and Standaert T. The aerolization efficiency of colistin is nebulizer


dependent. International Cystic Fibrosis Conference. 1997.

50. Geller D, Eigen H, Fiel S, Lemarre A, Konstan M and Johnson C. Aerosolized


dornase alfa in cystic fibrosis: Smaller particle size may improve outcome in
patients with mild obstructive lung disease. XIIth International Cystic Fibrosis
Congress. 1996.

51. Loffert D, Ikle D and Nelson H. A comparison of commercial jet nebulizers.


Chest 1994 106(6):1788-92.

52. Shah P, Scott S, Geddes D, Conway S, Watson A, Nazir T, Carr S, Wallis C,


Marriott C and Hodson M. An evaluation of two aerosol delivery systems for
rhDNase. Eur Respir J 1997 10(6):1261-6.

53. Coates A, MacNeish C, Lands L, Meisner D, Kelemen S and Vadas E. A


comparison of the availability of tobramycin ofr inhalation from vented vs
unvented nebulizers. Chest 1998 113(4):951-6.

54. Ho S and Coates A. Effect of dead volume on the efficiency and cost to deliver
medications in cystic fibrosis with four disposable nebulizers. Can Respir J
1999 6(3):253-60.

55. Katz S, Ho S and Coates A. Nebulizer choice for inhaled colistin treatment in
cystic fibrosis. Chest 2001 119(1):250-5.

56. Nerbrink O, Lindstrom M, Meurling L and Svartengren M. Inhalation and


deposition of nebulized sodium cromoglycate in two different particle size
distributions in children with asthma. Pediatr Pulmonol 2002 34(5):351-60.

57. Katz S, Adatia I, Louca E, Leung K, Humpl T, Reyes J and Coates A.


Nebulized therapies for childhood pulmonary hypertension: an in vitro model.
Pediatr Pulmonol 2006 41(7):666-73.

58. Dennis J. Drug Nebuliser Design and Performance: Breath Enhanced Jet vs.
Constant Output Jet vs. Ultrasonic. J Aerosol Med 1995 8(3):277-80.

CEP09018: October 2009


References 109

59. Smith E, Denyer J and Kendrick A. Comparison of twenty three


nebulizer/compressor combinations for domiciliary use. Eur Respir J 1995
8(7):1214-21.

60. Meditech. Medi-Mist Nebulizer Performance Data. [Received by post 18 Mar.


09]

61. Katial R, Reisner C, Buchmeier A, Bartelson B and Nelson H. Comparison of


three commerical ultrasonic nebulizers. Ann Allergy Asthma Immunol 2000
84(2):255-61.

62. Waldrep J, Berlinski A and Dhand R. Comparative analysis of methods to


measure aerosols generated by vibrating mesh nebulizer. J Aerosol Med 2007
20(3):310-9.

63. Johnson J, Clifford J, Guo J and Dhand R. Aerosol Delivery of Recombinant


Human DNase I: In Vitro Comparison of a Vibrating-Mesh Nebulizer With a Jet
Nebulizer. Respir Care 2008 53(12):1703-8.

64. Lass J, Sant A and Knoch M. New advances in aerosolised drug delivery:
vibrating membrane nebuliser technology. Expert Opin Drug Deliv 2006
3(5):693-702.

65. Li Z, Zhang Y, Wurtz W, Lee J, Malinin V, Durwas-Krishnan S, Meers P and


Perkins W. Characterization of nebulized liposomal amikacin (Arikace) as a
function of droplet size. J Aerosol Med Pulm Drug Deliv 2008 21(3):245-54.

66. Coates A, Green M, Leung K, Louca E, Tservistas M, Chan J, Ribeiro N and


Charron M. The challenges of quantitative measurement of lung deposition
using 99mTc-DTPA form delivery systems with very differen delivery times. J
Aerosol Med 2007 20(3):320-30.

67. Pari GmbH. Practitioner's information: Inhalation therapy with eFlow rapid:
Inhalation Solutions and Treatment Times. 2006.

68. Seeman S, Schmitt A, Waldner R, Hug M and Knoch M. Improving aerosol


drug delivery in CF therapy. 28th European Cystic Fibrosis Conference, 2005.

69. Rau J, Ari A and Restrepo R. Performance comparision of nebulizer designs:


constant-output, breath-enhanced, and dosimetric. Respir Care 2004
49(2):174-9.

CEP09018: October 2009


References 110

70. Newman S, Pitcairn G, Hooper G and Knoch M. Efficient drug delivery to the
lungs from a continuously operated open-vent nebulizer and low pressure
compressor system. Eur Respir J 1994 7(6):1177-81.

71. Barry P and O'Callaghan C. Drug output from nebulizers in dependent on the
method of measurement. Eur Respir J 1998 12(2):463-6.

72. Barry P and O'Callaghan C. An in vitro analysis of the output of salbutamol


from different nebulizers. Eur Respir J 1999 13(5):1164-9.

73. Barry P and O'Callaghan C. An in vitro analysis of the output of budesonide


from different nebulizers. J Allergy Clin Immunol 1999 104(6):1168-73.

74. Standaert T, Vandevanter D, Ramsey B, Vasiljev M, Nardella P, Gmur D,


Bredl C, Murphy A and Montgomery A. The choice of compressor effects the
aerosol parameters and the delivery of tobramycin from a single model
nebulizer. J Aerosol Med 2000 13(2):147-53.

75. Vecellio None L, Grimbert D, Becquemin M, Boissinot E, Le Pape A, Lemarie


E and Diot P. Validation of laser diffraction method as a substitute for cascade
impaction in the European Project for a Nebulizer Standard. J Aerosol Med
2001 14(1):107-14.

76. Asmus M, Milavetz G, Tice A and Teresi M. In vitro characteristics of


tobramycin aerosol from ultrasonic and jet nebulizers. Pharmacotherapy 2001
21(5):534-9.

77. Dennis J and Pieron C. Inhaled antibiotic therapy in evidence: what delivery
device?. J Cyst Fibros 2002 1(Suppl 2):209-14.

78. de Boer A, Hagedoorn P and Frijlink H. The choice of a compressor for the
aerosolisation of tobramycin (TOBI) with the PARI LC PLUS reusable
nebuliser. Int J Pharm 2003 268(1-2):59-69.

79. Rüdiger M, Gregor T, Burkhardt W, Proquitte H, Wauer R and Schmalisch G.


Perfluorocarbon species and nebulizer type influence aerosolization rate and
particle size perfluorocarbon aerosol. J Crit Care 2004 19(1):42-7.

80. Leung K, Louca E, Munson K, Dutzar B, Ankelsaria P and Coates A.


Calculating expected lung deposition of aerosolized administration of AAV
vector in human clinical studies. J Gene Med 2007 9(1):10-21.

CEP09018: October 2009


References 111

81. Majoral C, Vecellio L, Grimbert D, de Monto M, le Guellec C, Ingremeau V,


Minois C, Cordeau E, Paintaud G, Steinberg A and Diot P. New ipratropium
formulation to decrease nebulization time. Respir Med 2007 101(2):237-45.

82. Terzano C, Petroianni A, Parola D and Ricci A. Compressor/nebulizers


differences in the nebulization of corticosteroids. The CODE study
(Corticosteroids and Device Efficiency). Eur Rev Med Pharmacol Sci 2007
11(4):225-37.

83. Akapo S, Gupta J, Martinex E, McCrea C, Ye L and Roach M. Compatibility


and aerosol characteristics of formoterol fumarate mixed with other nebulizing
solutions. Ann Pharmacother 2008 42(10):1416-24.

84. Laube B, Geller D, Lin T, Dalby R, Diener-West M and Zeitlin P. Positive


expiratory pressure changes aerosol distribution in patients with cystic fibrosis.
Respir Care 2005 50(11):1438-44.

85. Respironics Respiratory Drug Delivery. An in vitro comparison of the impact of


jet nebulizer design an the aerosol characterization of commonly used asthma
druges.
http://www.respironics.com/ReferenceGuides/Piper%20Proof%20link%203%2
09.pdf [last accessed: 10 Jun. 09]

86. Pari. In-house test results. [Email correspondance 12 Dec. 2008]

87. Benstrup K, Newhouse M, Pedersen O and Jensen J. Characterization of


heparin aerosols generated in jet and ultrasonic nebulizers. J Aerosol Med
1999 12(1):17-25.

88. O'Riordan T, Weinstein M and Mao Y. Bench testing of nebulizers: a


comparison of three methods. J Aerosol Med 1999 12(2):59-66.

89. Reychler G, Keyeux A, Cremers C, Veriter C, Rodenstein D and Lüstro G.


Comparision of lung deposition in two types of nebulization: intrapulmonary
precussive ventilation vs jet nebulization. Chest 2004 125(2):502-8.

90. Devadason S, Everard M, Linto J and Le Soufe P. Comparison of drug


delivery from conventional versus "Venturi" nebulizers. Eur Respir J 1997
10(11):2479-83.

CEP09018: October 2009


References 112

91. Münster A, Bendstrup E, Jensen J and Gram J. Jet and ultrasonic nebulization
of single chain urokinase plasminogen activator (scu-PA). J Aerosol Med 2000
13(4):325-33.

92. Ho S, Kwong W, O'Drowsky L and Coates A. Evaluation of four breath-


enhanced nebulizers for home use. J Aerosol Med 2001 14(4):467-75.

93. Nikander K, Cruz-Rivera M and Smaldone G. Budesonide inhalation


suspension delivered via Ventstream breath-enhanced jet nebulizer. 2003 .

94. Gessler T and Schmehl T. Schill Multisonic InfraControl ultrasonic nebuliser: A


characterization of its physical features. TransMIT Center for Medical
Technology, Justus Liebig University. 2002.

95. Sommerer K. In-vitro characterization of drug output of nebulised Ventavis


solution with Multisonic IR nebulizer. Inamed. 2004.

96. Diot P, Foret D and Fouin J. Multisonic infraControl Ultrasonic nebuliser.


Federation Antadir. 2005.

97. Steckel H. Ultrasonic nebulisers: Multisonic top and profi. Pharmaceutical


Institute, University of Kiel. 2002.

98. Lewis R and Fleming J. Fractional deposition from a jet nebulizer: How it
differs from a metered dose inhaler. Br J Dis Chest 1985 79(4):361-7.

99. Clay M and Clarke S. Effect of nebulised aerosol size on lung deposition in
patients with mild asthma. Thorax 1987 42(3):190-4.

100. Nelson Laboratories. Nebulizer characterization study (Protocol No


200525905-01; Laboratory No 304526). Nelson Laboratories. 2005.

101. O'Doherty M, Thomas S, Page C, Clark A, Mitchell D, Heduan E, Nunan T and


Bateman N. Does 99Tcm human serum albumin alter the characteristics of
nebulized pentamidine isethionate?. Nucl Med Commun 1989 10(7):523-9.

102. Ilowite J, Baskin M, Sheetz M and Abd A. Delivered dose and regional
distribution of aerosolized pentamidine using different delivery systems. Chest
1991 99(5):1139-44.

CEP09018: October 2009


References 113

103. Hager J, Gober K, Lohr J and Durr M. Measurement of particle and mass
distributiuon of pentamidine aerosol by ultrasonic and air jet nebulizers. J
Aerosol Med 1992 5(2):65-79.

104. Diot P, Rivoire B, Le Pape A, Lemarie E, Dire D, Firet Y, Breteau M and


Smaldone G. Deposition of amphotericin B aerosols in pulmonary
aspergilloma. Eur Respir J 1995 8(8):1263-8.

105. O'Doherty M, Thomas S, Page C, Bradbeer C, Nunan T and Bateman N. Does


inhalation of pentamidine in the supine position increase deposition in the
upper part of the lung?. Chest 1990 97(6):1343-8.

106. Simonds A, Newman S, Johnson M, Talaee N, Lee C and Clarke S. Alveolar


targeting of aerosol pentamidine. Toward a Rational Delivery System. Am Rev
Respir Dis 1990 141(4 Pt 1):827-9.

107. Smaldone G, Fuhrer J, Steigbigel R and McPeck M. Factors determining


pulmonary deposition of aerosolized pentamidine in patients with human
immunodeficiency virus infection. Am Rev Respir Dis 1991 143(4 Pt 1):727-
37.

108. Hardy J, Newman S and Knoch M. Lung deposition from four nebulizers.
Respir Med 1993 87(6):461-65.

109. O'Riordan T and Smaldone G. Regional deposition and regional ventialtion


during inhalation of pentamidine. Chest 1994 105(2):396-401.

110. Waldrep J, Keyhani K, Black M and Knight V. Operating characteristics of 18


different continuous-flow jet nebulizers with beclomethasone dipropionate
liposome aerosol. Chest 1994 105(1):106-10.

111. Di Paolo E, Pannatier A and Cotting J. In vitro evaluation of bronchodilator


drug delivery by jet nebulization during pediatric mechanical ventilation.
Pediatr Crit Care Med 2005 6(4):462-9.

112. Leasing. http://www.pasa.nhs.uk/pasaweb/productsandservices/leasing, 2008.

113. Preparing a business case.


http://www.ogc.gov.uk/documentation_and_templates_business_case.asp,
2009.

CEP09018: October 2009


References 114

114. OPPM - operational purchasing procedure manual.


http://nww.pasa.nhs.uk/PASAWeb/Guidance/OPPM/LandingPage.htm, 2008.

115. European Union Tendering Timetable.


http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPro
curement/DH_4070620, 2004.

116. Desk guide to procurement - 2005 edition.


http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPro
curement/DH_4109316, 2005.

CEP09018: October 2009


Appendix 1: Summary of evidence 115

Table 8. Summary of economic studies


Authors Study design Results Conclusions Limitations

Leversha A randomised, double-blind, The study found that wheezing The MDI and • Small study
et al placebo controlled trial with a was reduced more in the spacer spacer combination population.
(2002) [9] study population of 60 group after the first treatment was a more cost-
• No sensitivity
children. 30 children were than in the nebulizer group and effective alternative
analysis of
treated with albuterol there were significantly smaller than a nebulizer in
economic
delivered via an MDI and increases in heart rate in the delivery of albuterol
model.
spacer, then given a placebo spacer group. The two groups in young children.
via a nebulizer. The other 30 did not differ in clinical severity • Applicable to
children were treated with score, respiratory rate and children.
albuterol delivered via a oxygen saturation in response
nebulizer, then given a to the first treatment. Over the
placebo via an MDI and whole study the absolute
spacer. The primary change in clinical score was
outcomes were clinical similar in the two groups. Of the
severity, heart rate, children in the spacer group,
respiratory rate, oxygen 33% required admission to
saturation rate, wheezing at hospital compared with 60% in
60 minutes, admission to the nebulizer group. The median
hospital and visits to the number of treatments required
emergency departments at was 4.0 in the spacer group and
48 hours. Costs were 4.5 in the nebulizer group. The
calculated from the cost of study indicated that the MDI and
medication, equipment, spacer combination was more
emergency department effective, quicker and had fewer
presentation for those side effects that the nebulizer.
requiring admission and the The mean total cost of each
cost of the resulting emergency department
admission. Due to the short presentation was NZ$285 for
duration of the study, no the spacer group and NZ$1282
discounting was applied for the nebulizer group.

CEP09018: October 2009


Appendix 1: Summary of evidence 116

Table 8. Summary of economic studies (continued)


Authors Study design Results Conclusions Limitations

Iles et al There were two designs; a The between-group analysis The use of TNS for • Not a
(2005) [10] retrospective comparative showed that lung function in treatment of randomised
study using historical controls both groups decreased with a patients with control trial.
to carry out a between-group net effect in favour of TNS moderate or severe
• Small study
comparison and a within- patients. The mean body weight CF led to
population.
group comparison study to in both groups increased with a reductions in
compare tobramycin net effect in favour of TNS hospital attendance • The comparator
nebulizer solution (TNS) patients. There was a reduction and IV antibiotic “usual therapy”,
patients before and after TNS in the mean total number of administrations, which
treatment. Patients were days in hospital in both groups, which was also represented
followed for two years in the but the results were affected by expected to current practice
TNS group and for one year an outlier in the control group. improve the in the authors’
in the “usual therapy” group. Both groups showed a reduction patient’s quality of setting, was not
There were 71 patients in the number of clinic life. The higher described.
included in the study; 41 attendances and ward costs of TNS • No sensitivity
treated with TNS and 30 with admissions. The TNS patients treatment was analysis of
the “usual therapy”. The had a decreased number of partially offset by economic
primary outcomes were lung outpatient visits and IV courses, other savings. model.
function and body weight. but increases were observed for
Also recorded were the the control group. The TNS • Not all costs
number of days in hospital, group had a slight increase in were included.
the number of days of ICU admissions, where there
intravenous (IV) was a decrease in the control
administration, the number of group. There was a reduction of
clinic visits, the number of 241 days of IV antibiotic
outpatient visits, IV courses, treatment in the TNS group with
ward admissions and no change in the controls. The
intensive care unit (ICU) within-group analysis showed
admissions. Health Service that lung function declined
costs were analysed between the year before and
including the cost of TNS, after TNS treatment. The mean
drugs (eg antibiotics) and weight increased. Reductions
hospitalisation (both ward were observed in the number of
and ICU), as well as costs days in hospital, number of days
related to other health care of IV administration, number of
interventions (eg intercurrent clinics attended, number of IV
illnesses and surgical courses and the number of ward
procedures). These costs admissions. There were no
were reported along with changes in the number of
mean resource quantities, outpatient visits but there was
and were obtained from an increased in the number of
medical records and from ICU admissions. In the sub-
NHS reference data. Cost group of young patients, lung
analysis was undertaken for function and mean weight
the 41 TNS patients and a increased. Reductions were
sub-group of 19 young observed in all other clinical
patients. The time horizon outcomes. In the TNS group,
used for estimation of costs the mean total cost per patient
was one year for each was £28,394 in the year in
treatment strategy, so no which TNS was administered
discounting was applied. and £22,102 in the year
preceding TNS treatment. In the
sub-group of young patients, the
total cost per patient was
£28,080 in the year which TNS
was administered and £24,250
in the year preceding TNS
treatment.

CEP09018: October 2009


Appendix 1: Summary of evidence 117

Table 9. Summary of in vitro performance testing of Aerogen nebulizers


Device Author Method Results
Aeroneb Go Majoral et al Compares different methods of Measured (EN13544-1): MMAD (± SD) =
(2006) [15] processing data collected from cascade 5.0 ± 0.1 µm; RF (± SD) = 49 ± 2 %. Log-
impactor measurements: EN13544-1; normal: MMAD (± SD) = 5.2 ± 0.6 µm; RF
Log-normal; Calibration matrix. Tested (± SD) = 47 ± 6 %. Calibration matrix:
with NaF. Used 8-stage Marple model MMAD (± SD) = 5.6 ± 0.1 µm; RF (± SD) =
298 cascade impactor. 44 ± 2 %.
Aeroneb Go Dennis et al Compared test results from five Measured (average): MMAD = 3.78 µm
(2008) [16] different laboratories for three types of (ambient), 4.16 µm (cool); GSD = 2.05
nebulizers (Aeroneb Go: vibrating (ambient), 2.00 (cool); FDF (fine droplet
mesh; PARI LC Plus: breath enhanced; fraction) = 65.2 % (ambient), 60.5 %
Misty Max: constant output jet) using a (cool). Found that the cooled NDI yielded
pre-cooled (5°C for 90 minutes) NGI a coarser nebulized aerosol. MMAD was
and an ambient temperature NGI. reduced by 9.5-21.9 %. Variability was
Salbutamol solution (5 mg/2 ml). similar for both cooled and ambient NGI.
Aeroneb Go Poster by Compared Aeroneb Go with PARI LC Measured: MMAD = 3.1 µm; FPF (< 5.8
Simmons et al Star and Omron MicroAir. Inhaled µm) = 83 %; residual medication = 11 % of
(2008) [17] Albuterol Sulphate (2.5 mg/3 ml) dose volume (constant air draw, 0.45
collected on filter between nebulizer ml/minute flow rate), 17 % of dose volume
and Hans Rudolph breathing simulator (adult breathing pattern); respirable mass
(adult pattern). Particle size determined during adult breathing pattern = 945 µg;
using Anderson Mk. II cascade respirable mass = 31 % by MMAD;
impactor. treatment time = 6 minutes.
Aeroneb Go In-house test Tested nebulizer using NaF. Particle Measured: MMAD = 2.9 µm; output rate =
results [18, 19] size determined using 8-stage Marple 0.24 ml/min; total output = 1.08 ml.
model 298 cascade impactor. Test
protocol supplied by Aeroneb shows
that testing is to EN13544-1: 2007.
Aeroneb Pro Pederson et al Used nebulizer connected to a Measured: MMAD = ~3 µm; percentage of
(2006) [20] ventilator circuit (Siemens 300 nominal dose depended on endotracheal
ventilator) with Tobramycin (6.0 ml tube size and respiratory minute volume
solution: 50 mg/ml Tobramycin in H2O). setting.
Used a Malvern 2600c laser particle
size analyser.
Aeroneb Pro Fink (2007) [21] Nebulizer used during adult mechanical Measured: MMAD = 2.1 µm; GSD = 2.2;
ventilation to deliver Albuterol Sulphate. FPF (< 5 μm) = 83.2 %; residual volume =
Measurements made at distal tip of an 0.4 ml; dose deposit = 315 μg; percentage
8.0 mm ET tube. dose deposit = 13%.
Aeroneb Pro Ghazanfari et al Tested the nebulizer with five different Measured: VMD ranged between 4.09-
(2007) [22] solutions: Glycerol solution; NaCl; 5.94 µm; fine particle fraction (FPF)
Ethanol; Silica Fluid; Deionised Water. ranged between 28.05-57.30 %; total
Particle size measured using Malvern aerosol output ranged between 58.06-
2600 laser diffraction analyser. 90.98 %; aerosol output rate ranged
between 0.22-0.83 ml/minute; nebulization
time ranged between 5.21-18.34 minutes.
Aeroneb Pro Ferrari et al Nebulized with 1 g of Cetazidime in a Measured: MMAD = 2.35 μm (at outlet of
(2008) [23] respiratory circuit connected to piglets. nebulizer), 2.42 μm (at tip of ET tube);
Particle size measured using Malvern GSD = 1.57 (at outlet of nebulizer), 1.60
laser particle sizer. (at tip of ET tube); aerosol deposition (in
10 piglets).
Aeroneb Pro In-house test Tested nebulizer using NaF. Particle Measured: MMAD = 3.5 µm; output rate =
results [18, 19] size determined using 8-stage Marple 0.30 ml/min; total output = 1.02 ml.
model 298 cascade impactor. Test
protocol supplied by Aeroneb shows
that testing is to EN13544-1: 2007.
Aeroneb Solo In-house test Tested nebulizer using NaF. Particle Measured: MMAD = 3.5 µm; output rate =
results [18, 19] size determined using 8-stage Marple 0.25 ml/min; total output = 0.86 ml.
model 298 cascade impactor. Test
protocol supplied by Aeroneb shows
that testing is to EN13544-1: 2007.

CEP09018: October 2009


Appendix 1: Summary of evidence 118

Table 10. Summary of in vitro performance testing of Cardinal Health nebulizers


Device Author Method Results
Misty Max Dennis et al Compared test results from five Measured (average): MMAD = 3.89 µm
(2008) [16] different laboratories for three types of (ambient), 4.86 µm (cool); GSD = 2.41
nebulizers (Aeroneb Go: vibrating (ambient), 2.29 (cool); FDF (fine droplet
mesh; PARI LC Plus: breath enhanced; fraction) = 61.4 % (ambient), 51.6 %
Misty Max: constant output jet) using a (cool). Found that the cooled NDI yielded
pre-cooled (5°C for 90 minutes) NGI a coarser nebulized aerosol. MMAD was
and an ambient temperature NGI. reduced by 9.5-21.9 %. Variability was
Salbutamol solution (5 mg/2 ml). similar for both cooled and ambient NGI.
Misty Max 10 In-house test Compared the Misty Max 10 with the Measured: MMAD = 1.61 µm; GSD =
report [24] Westmed VixOne, Hudson Micro Mist 2.18; RF (< 4.7 µm) = 85.2 %; output rate;
and Salter 8900. Used Albuterol treatment time = 8.9 minutes; residual
Sulphate. Particle size measured using volume = 1310 µg; inhaled respirable
Anderson 8-stage cascade impactor. mass = 383 µg.
Misty Max 10 In-house test Compared the Misty Max 10 with the Measured: MMAD = 1.61 µm; GSD =
report [25] Hudson Micro Mist. Used Albuterol 2.18; RF(< 4.7 µm) = 85.2 %; residual
solution. 8 l/minute flow rate. Particle volume = 1237 µg ; inhaled respirable
size measured using Anderson 8-stage mass after 4, 6 and 8 minutes = 247, 350
cascade impactor. and 383 µg.

Table 11. Summary of in vitro performance testing of Clement-Clarke nebulizers


Device Author Method Results
Micro-Neb III Hung et al Used three different compressors: Measured (shown graphically): MMAD;
(1994) [26] Portaneb 50, Turboneb and CR60 RF; nebulization time; residual volume;
along with three different antibiotics: percentage dose released for the different
Gentamicin (80 mg/2 ml), Ciprofloxacin combinations of compressor and
(2 mg/ml) and colomycin 1 MU or 80 antibiotic.
mg. Used Malvern 2600 HSD laser
particle size analyser.
Micro-Neb III Hurley et al Tested nebulizer using Maxi III Measured (Amphotericin; Colomycin;
(1994) [27] compressor at 101 l/min with four Tobramycin; Gentamicin): MMD = 3.11,
different antibiotics: Amphotericin; 3.43, 3.30, 3.36 µm; respirable fraction,
Colomycin; Tobramycin; Gentamicin RF (< 5.17 µm) = 76, 69, 72, 73 %;
and five fill volumes: 2, 3, 4, 5, 6 ml. percentage mass released as aerosol
Particle size measured with Malvern (shown graphically); nebulization time
Instruments Mastersizer laser particle ranging from 351-1963 seconds
size analyser. depending on fill volume and drug.
Micro-Neb III Hurley & Smye Performance of 14 jet nebulizers was Measured: MMD = 2.83 µm; nebulization
(1994) [28] compared using 4 ml of 0.9% Saline time = 829 seconds; percentage drug
and 10 l/min flow rate. Relevant released as aerosol = 68 %; rate of drug
nebulizers: Micro Cirrus, Respironics emission = 2.11 mg/minute.
Sidestream, Clement-Clarke Micro-Neb
III, Huson Up-Draft and Up-Draft II.
Particle size measured using Malvern
laser particle size analyser.
Micro-Neb III In-house test States that performance information is Measured: aerosol output = 0.36
report [29] in accordance with BS EN 13544-1: ml/minute; aerosol output per minute =
2001. Used Nebular compressor at 6.7 0.064 ml; cumulative mass distribution
l/minute; 84 kPa. 2.5 ml NaF test curve shown graphically; numerical results
solution from 8-stage cascade impactor.

CEP09018: October 2009


Appendix 1: Summary of evidence 119

Table 12. Summary of in vitro performance testing of DeVilBiss nebulizers


Device Author Method Results
Ultraneb Véra P et al Tested nebulizer with Measured: MMAD = 1.32 μm (MP), 2.07
(1995) [30] Methylprednisolone (MP) and μm (MP + HSA); GSD = 1.53 (MP), 1.90
Methylprednisolone labelled with (MP + HSA).
99mTc human serum albumin (MP
+HAS). 4 ml fill volume.
Ultraneb O’Riordan & Tested nebulizer using Tobramycin with Measured: MMAD ranged from 1.45-4.30
Amram (1997) radiotracer (1-5 mCi 99mTc). Used µm; percentage drug inhaled ranged from
[31] cascade impactor to determine droplet 5.2-30.6 %.
size.
UItraneb Weber et al Tested nebulizer using: saline (0.9 % Measured: MMAD (shown graphically);
(1997) [32] w/w Sodium Chloride in distilled water); aerosol output rate (Saline) = 2.22
Gentamicin; Tobramycin Sulphate; ml/minute; RF (percentage particle
Ceftazidime Sodium salt; Ciprofloxacin; between 1-5 µm ranged from 89-95 %.
Colistimethate Sodium. Used Malvern Also given are osmolality, viscosity, pH
Mastersizer (laser) to determine particle and surface tension for antibiotic solutions.
size.

Table 13. Summary of in vitro performance testing of Flaem Nuova nebulizers


Device Author Method Results
RF6 Basic Summary of Compared Flaem Nuova RF5 Plus Measured: MMAD = 3.5 µm; GSD = 1.85;
independent (used F2000, F1000 and F400 FPF = 72 % (F400); output rate = 62
testing by compressor), RF6 Plus (used F2000 µl/minute; total output = 300 µl (F400);
Inamed and F1000 compressor), RF6 Basic residual volume = 1.15 ml.
Research GmbH (used F400 compressor), PARI LC Plus
& Co. KG [33] (used F2000 and F1000 compressor)
and Respironics Ventstream (used
F2000 and F1000 compressor). Tested
nebulizers to EN 13544-1. Used 8-
stage Anderson Mk II cascade impactor
to determine particle size.
RF6 Basic Independent Claimed testing to EN 13544-1: 2001. TÜV certificate and results data (shown
testing by graphically) of in-vitro characterisation of
Inamed particle size and output
Research GmbH
& Co. KG [35]
RF6 Plus Summary of Compared Flaem Nuova RF5 Plus Measured: MMAD = 2.8 µm (F2000), 3.2
independent (used F2000, F1000 and F400 µm (F1000); GSD = 2.15 (F2000), 2.04
testing by compressor), RF6 Plus (used F2000 (F1000); FPF = 76 % (F2000), 73 %
Inamed and F1000 compressor), RF6 Basic (F1000); output rate = 106 µl/minute
Research GmbH (used F400 compressor), PARI LC Plus (F2000), 85 µl/minute (F1000); total output
& Co. KG [33] (used F2000 and F1000 compressor) = 475 µl (F2000), 433 µl (F1000); residual
and Respironics Ventstream (used volume = 1.24 ml (F2000), 1.27 ml
F2000 and F1000 compressor). Tested (F1000).
nebulizers to EN 13544-1. Used 8-
stage Anderson Mk II cascade impactor
to determine particle size.
RF6 Plus Independent Claimed testing to EN 13544-1: 2001. TÜV certificate and results data (shown
testing by graphically) of in-vitro characterisation of
Inamed particle size and output
Research GmbH
& Co. KG [35]

CEP09018: October 2009


Appendix 1: Summary of evidence 120

Table 14. Summary of in vitro performance testing of Hudson RCI nebulizers


Device Author Method Results
Micro Mist Hess et al (1996) Tested nebulizer using Albuterol and Measured (data represented graphically):
[36] saline solution. Measured particle size MMAD; GSD; respirable mass; inhaled
using 11-stage cascade impactor at 3 mass; dead volume; nebulization time.
different flow rates.
Micro Mist Standaert et al The paper considers the effect on Baseline assessment with Saline values
(1998) [37] performance of disposable nebulizers were: MMD = 5.20 ± 0.30 µm; GSD = 1.86
when repeatedly re-used. Four ± 0.08; percentage of aerosol in the range
solutions were used: 0.9% saline 1-3 µm = 14.7 ± 3.3 %; percentage of
(baseline); Gentamicin Sulfate in saline; aerosol in the range 1-5 µm = 41.4 ± 6.4
Tobramycin; Albuterol Sulphate and %; continuous output = 0.168 ± 0.013
Cromolyn solution. ml/minute; nebulization duration = 23.6 ±
2.2 minutes; residual volume = 1.53 ± 0.12
ml. Data for other solutions was largely
presented in graphical form.
Micro Mist Reisner et al Tested nebulizer with Saline and Measured (shown at 5 l/minute): volume
(2001) [38] Albuterol at four different flow rates: 2, median diameter (VMD) = 0.58; GSD =
3, 4 and 5 l/minute. Used PMS CSASP- 1.79; percentage particles in respirable
100 laser particle size analyser to range (1-5 µm) = 54 %; volume nebulized
determined droplet size. = 1.678 ml; total volume delivered in
respirable range = 0.91 ml; respirable rate
= 0.1114 ml/minute; time taken for
nebulization = 488 seconds.
Micro Mist Wong-Beringer Tested nebulizer with Pulmo-Aide Measured: RF = 85 % for 10 mg/ml and
et al (2005) [39] compressor using Caspofungin 0.9% 38 % for 30 mg/ml; output rate (shown
NaCl at two concentrations: 10 mg/ml graphically).
and 30 mg/ml. Particle size determined
using API Aerosizer time-of-flight
aerosol spectrometer.
Micro Mist Zhou Y et al Tested nebulizer with Albuterol solution Measured: 22°C: MMAD = 1.58 µm; GSD
(2005) [40] at 10 and 22°C. Measured particle size = 1.84; RF = 35.13 %. 10°C: MMAD =
using Anderson 8-stage cascade 4.23 µm; GSD = 2.22; RF = 26.42 %.
impactor.
Micro Mist Independent test Tested nebulizer with old and new Measured: MMAD = 3.2 µm (old), 2.7 µm
report by Piper design 22 mm cap using Saline with (new); GSD = 3.9 (old), 3.9 (new).
Medical 1mg/ml of Fluoroscein at 8 l/minute flow
Products [41] rate. Used cascade impactor to
measure particle size distribution.
Micro Mist Cardinal Health Compared the Misty Max 10 with the Measured: MMAD = 2.43 µm; GSD =
in-house test Westmed VixOne, Hudson Micro Mist 2.72; RF (< 4.7 µm) = 68.1 %; output rate;
report [24] and Salter 8900. Used Albuterol treatment time = 8.1 minutes; residual
Sulphate. Particle size measured using volume = 1418 µg; inhaled respirable
Anderson 8-stage cascade impactor. mass = 274 µg.
Micro Mist Cardinal Health Compared the Misty Max 10 with the Measured: MMAD = 2.43 µm; GSD =
In-house test Hudson Micro Mist. Used Albuterol 2.72; RF(< 4.7 µm) = 68.1 %; residual
report [25] solution. 8 l/minute flow rate. Particle volume = 1362 µg ; inhaled respirable
size measured using Anderson 8-stage mass after 4, 6 and 8 minutes = 199, 232
cascade impactor. and 254 µg.
Micro Mist Independent Compared the Unomedical Opti-Mist Measured MMAD; GSD; residual volume
testing by Plus and Up-Mist with Salter Labs at normal, 45° and 90° orientations;
Nelson 8900, Huson Micro Mist, Intersurgical minimum fill volume at normal, 45° and
Laboratories, Cirrus and Philips Respironics 90° orientations; non-spill volume.
Inc. [42] Sidestream. Tested nebulizers using
0.9% Saline, at 23 ± 2°C, 40-60% RH
following Australian/New Zealand
Standard 4236:1994 and US FDA
requirements, 1993. Measured particle
size using Anderson 8-stage cascade
impactor.

CEP09018: October 2009


Appendix 1: Summary of evidence 121

Table 14. Summary of in vitro performance testing of Hudson RCI nebulizers (continued)
Device Author Method Results
Up-Draft Sterk et al Tested nebulizer using Saline. Particle Measured: volume median aerodynamic
(1984) [43] size determined using a differential diameter (VMAD) which is equivalent to
mobility aerosol analyser (TSI-3071). MMAD = 0.46-0.58 µm; GSD = 1.90-1.94
depending on flow; aerosol output rate =
155-256 mg/min; output per litre of air =
26-32 mg/l depending on flow; particle
concentration per millilitre of air = 5.0-11.8
x 106 /ml; solute output per millilitre of air =
23-78 x 10-9 ml.
Up-Draft Hunke & Yu Tested nebulizer using PulmoAide Measured: average particle size = 3.19 ±
(1987) [44] compressor with Bitolterol Mesylate 1.9 µm and 3.0 ± 1.8 µm; percentage drug
solution 0.2 % diluted with 0.9 % captured by each stage of the cascade
Sodium Chloride solution. Particle size impactor.
distribution was determined using
Anderson cascade impactor.
Up-Draft Hurley et al Tested nebulizer using Maxi III Measured (Amphotericin; Colomycin;
(1994) [27] compressor at 101 l/min with four Tobramycin; Gentamicin): MMD = 4.27,
different antibiotics: Amphotericin; 4.40, 4.65, 4.21 µm; respirable fraction,
Colomycin; Tobramycin; Gentamicin RF (< 5.17 µm) = 62, 60, 57, 62 %;
and five fill volumes: 2, 3, 4, 5, 6 ml. percentage mass released as aerosol
Particle size measured with Malvern (shown graphically); nebulization time
Instruments Mastersizer laser particle ranging from 299-2032 seconds
size analyser. depending on fill volume and drug.
Up-Draft Hurley & Smye Performance of 14 jet nebulizers was Measured: MMD = 4.24 µm; nebulization
(1994) [28] compared using 4 ml of 0.9% Saline time = 637 seconds; percentage drug
and 10 l/min flow rate. Relevant released as aerosol = 39.5 %; rate of drug
nebulizers: Micro Cirrus, Respironics emission = 1.76 mg/minute.
Sidestream, Clement-Clarke Micro-Neb
III, Huson Up-Draft and Up-Draft II.
Particle size measured using Malvern
laser particle size analyser.
Up-Draft Conference Used Sidestream/Mobilaire and Hudson Measured: MMAD = 4.9 µm; delivery time
presentation Up-Draft/Pulmo-aide = 8.1-10.3 minutes.
summary by nebulizer/compressor with Dornase Alfa
Geller et al (nhDNase) in clinical trail on 749 cystic
(1996) [50] fibrosis patients
Up-Draft Hess et al (1996) Tested nebulizer using Albuterol and Measured (data shown graphically):
[36] saline solution. Measured particle size MMAD; GSD; respirable mass; inhaled
using 11-stage cascade impactor at 3 mass; dead volume; nebulization time.
different flow rates.
Up-Draft Conference Compared the performance of five Measured: MMD = 4.3 µm; RF
presentation nebulizers: PARI LC Star and LC Plus; (percentage of aerosol in 1-5 µm range) =
abstract by Philips Respironics Sidestream and 48 %; output = 0.11 ml/minute;
Geller & Ventstream; Hudson Updraft. Used nebulization time = 27.7 minutes;
Standaert (1997) Colistimethate (Colymycin) 150 mg percentage delivered = 36 %.
[49] dissolved in 4 cc H2O.
Up-Draft MacNeish et al Tested nebulizer using VRS mixed with Measured: MMD = 4.90 ± 0.3 µm – 6.30 ±
(1997) [45] 2 ml of saline and 2.5 mg Albuterol pre- 0.3 µm; RF = 0.36 -0.52; total drug output
diluted with saline. Measured particle (mg); drug availability (drug output x RF);
size using Malvern 2600 laser particle dead volume; nebulization time.
sizer at three different flow rates.
Up-Draft Tandon et al Tested nebulizer using Albuterol in Measured: percentage weight change =
(1997) [46] saline with 99mTc tracer. Aerosol 64.554 %; percentage aerosol produced =
output rate was determined 38.761 %.
gravimetrically and by measuring
radioactivity.

CEP09018: October 2009


Appendix 1: Summary of evidence 122

Table 14. Summary of in vitro performance testing of Hudson RCI nebulizers (continued)
Device Author Method Results
Up-Draft Le Brun et al Tested nebulizer with Tobramycin. Measured: MMD = 2.81 µm; mean output
(1999) [47] Used Pulmo-Aide compressor. Used rate = 10.4 ± 3.2 mg/min; nebulization
Sympatec HELOS (laser diffraction) to time = 12 minutes.
determine particle size.
Up-Draft Berlinski & Tested nebulizer with Albuterol and five Measured: MMAD ranged between 1.29-
Waldrep (2006) different admistures: Albuterol; 2.98 µm; GSD ranged between 2.66-3.36;
[48] Albuterol combined with Ipratopium RF (0.4-5.0 µm) ranged between 66-82 %;
Bromide; Albuterol combined with total drug output = 1.5-1.7 ml.
Cromolyn Sodium; Albuterol combined
with Tobramycin; Albuterol combined
with N-acetylcysteine; Albuterol
combined with Flunisolide at 8 l/minute
flow rate. Partcile size distribution
determined using Anderson cascade
impactor.
Up-Draft II Hurley et al Tested nebulizer using Maxi III Measured (Amphotericin; Colomycin;
(1994) [27] compressor at 101 l/min with four Tobramycin; Gentamicin): MMD = 2.16,
different antibiotics: Amphotericin; 2.44, 2.51, 3.18 µm; respirable fraction,
Colomycin; Tobramycin; Gentamicin RF (< 5.17 µm) = 88, 82, 80, 71 %;
and five fill volumes: 2, 3, 4, 5, 6 ml. percentage mass released as aerosol
Particle size measured with Malvern (shown graphically); nebulization time
Instruments Mastersizer laser particle ranging from 474-3630 seconds
size analyser. depending on fill volume and drug.
Up-Draft II Hurley & Smye Performance of 14 jet nebulizers was Measured: MMD = 2.24 µm; nebulization
(1994) [28] compared using 4 ml of 0.9% Saline time = 1659 seconds; percentage drug
and 10 l/min flow rate. Relevant released as aerosol = 51.5 %; rate of drug
nebulizers: Micro Cirrus, Respironics emission = 0.801 mg/minute.
Sidestream, Clement-Clarke Micro-Neb
III, Huson Up-Draft and Up-Draft II.
Particle size measured using Malvern
laser particle size analyser.
Up-Draft II Loffert et al Tested nebulizer with Albuterol (0.5 ml Measured: total volume output = 1.62 ml;
(1994) [51] + 2 ml saline) using DeVilBiss time of total output = 11.94 minutes;
Pulmoaide 5610D compressor. PMS percentage of particles in respirable range
CSASP-100 laser diffractometry particle (1-5 μm) = 40.16 %; respirable rate =
size analyser used. 0.0547 ml/minute.
Up-Draft II Hess et al (1996) Tested nebulizer using Albuterol and Measured (data represented graphically):
[36] saline solution. Measured particle size MMAD; GSD; respirable mass; inhaled
using 11-stage cascade impactor at 3 mass; dead volume; nebulization time.
different flow rates.

Up-Draft II MacNeish et al Tested nebulizer using VRS mixed with Measured: MMD = 4.50 ± 0.3 µm – 5.90 ±
(1997) [45] 2 ml of saline and 2.5 mg Albuterol pre- 0.3 µm; RF = 0.40 -0.61; total drug output
diluted with saline. Measured particle (mg); drug availability (drug output x RF);
size using Malvern 2600 laser particle dead volume; nebulization time.
sizer at three different flow rates.

Up-Draft II Shah et al Tested nebulizer with rhDNase using Measured: MMAD = 6.87 µm; percentage
(1997) [52] PulmoAide compressor. Measured of aerosol by mass in the respirable range
particle size using Malvern 2600 laser (1.0-5.6 µm), RF = 35 %; aerosol output =
particle analyser. 16 %; nebulization time; nebulizer
efficiency (ratio of dry weight to respirable
output).

CEP09018: October 2009


Appendix 1: Summary of evidence 123

Table 14. Summary of in vitro performance testing of Hudson RCI nebulizers (continued)
Device Author Method Results
Up-Draft II Weber et al Tested nebulizer using: saline (0.9 % Measured: MMAD (shown graphically);
(1997) [32] w/w Sodium Chloride in distilled water); aerosol output rate (Saline) = 0.20
Gentamicin; Tobramycin Sulphate; ml/minute (PulmoAide), 0.25 ml/minute
Ceftazidime Sodium salt; Ciprofloxacin; (PARI Master); RF (percentage particle
Colistimethate Sodium. Used two between 1-5 µm ranged from 40-52 %.
differenent compressors: Pulmo-Aide Also given are osmolality, viscosity, pH
and PARI Master. Used Malvern and surface tension for antibiotic aerosol
Mastersizer (laser) to determine particle solutions.
size.
Up-Draft II Coates et al Tested nebulizer with Tobramycin and Measured: particle size values not
(1998) [53] saline solution. Particle size determined reported; aerosol output = 55 mg; total
using Malvern 2600 particle sizer. output in RF = 22 mg.
Up-Draft II Standaert et al Considered the effect on performance Baseline assessment with Saline values
(1998) [37] of disposable nebulizers when were: MMD = 4.94 ± 0.28 µm; GSD = 2.11
repeatedly re-used. Four solutions were ± 0.13; percentage of aerosol in the range
used: 0.9% saline (baseline); 1-3 µm = 17.9 ± 1.8 %; percentage of
Gentamicin Sulfate in saline; aerosol in the range 1-5 µm = 42.7 ± 3.9
Tobramycin; Albuterol Sulphate and %; continuous output = 0.198 ± 0.023
Cromolyn solution. ml/minute; nebulization duration = 20.6 ±
2.2 minutes; residual volume = 1.29 ± 0.14
ml. Data for other solutions was largely
presented in graphical form.
Up-Draft II Ho & Coates Tested nebulizer with Saline, Measured: MMD = 4.78 µm at low flow,
(1999) [54] Salbutamol and Tobramycin at two 3.77 µm at high flow using Saline; RF
different flow rates: 6 and 8 l/minute. (shown graphically); nebulization time
Used Malvern Mastersizer X (laser ranged between 10.5-13.8 minutes at 6
diffractometry) to determine particle l/minute and 8.7-11.2 minutes at 8
size. l/minute.
Up-Draft II Katz et al (2001) Tested nebulizer using Colistin with and Measured: MMD = 3.4-4.3 µm depending
[55] without Ethanol. Dtermined droplet size on Ethanol dose; RF = 59 or 68 %
using MasterSizer-X. depending on Ethanol dose; total drug
output = 38.5-41.7 mg depending on
Ethanol dose; total drug output in the
respirable range = 23.7-26.3 mg
depending on Ethanol dose; output rate.
Up-Draft II Nerbrink et al Tested nebulizer to EN13544-1 with NaF: MMAD = 1.3 µm (13% RH), 2.3 µm
(2002) [56] NaF but also with Sodium (90% RH); mass output = 2768 ± 120 mg
Cromoglycate. Particle size determined during 50 1 second breathing cycles for all
using Anderson cascade impactor. RH. Sodium Cromoglycate had almost
Measurements performed at 13 and identical particle size distribution and
90% relative humidity. putput.
Up-Draft II Katz et al (2006) Tested nebulizer with three different Measured: Total drug output = 58.17 %
[57] drug solutions: Sildenafil; Tezasentan; (mean); output rate (graphical)
Prostacyclin. Particle size determined
using Malvern Mastersizer X (laser
diffraction).

CEP09018: October 2009


Appendix 1: Summary of evidence 124

Table 15. Summary of in vitro performance testing of Intersurgical nebulizers


Device Author Method Results
Cirrus Dennis (1995) Tested various nebulizer/compressor Measured: MMAD = 4.62 μm; percentage
[58] combinations: PARI LC Plus/PARI Boy, particles size < 5 μm = 58.2 %; total
PARI LC Plus/PARI Master, inhaled = 45.9 μl, inhaled < 5 μm = 26.7
Respironics Ventstream/CR50, μl, inhaled > 5 μm = 19.2 μl and waste =
Respironics Sidestream/Portaneb and 46.1 μl for 60 seconds of nebulization.
Intersurgical Cirrus/Pulmoaide using 1 Data for 2 ml and 3 ml fill volumes was
% Sodium Fluoride with patient also given.
breathing simulator. Measured Particle
size using Malvern 2600 laser particle
sizer.
Cirrus Smith et al Tested nebulizer with a number of Measured: MMAD = 3.9-7.6 µm for 2.5 ml
(1995) [59] different compressors: Aeroneb and 4.1-7.7 µm for 5.0 ml; % < 5 µm = 28-
Standard, Aeroneb High Power, Medix 62 % for 2.5 ml and 28-61 % for 5.0 ml
2000, Medix Traveller, Medix Minor, depending on compressor used;
Novair II. Used sterile water (2.5 ml and compressor noise output; compressor
5.0 ml fill volumes) and Malvern Master energy consumption; volume output after
Sizer MS20 (laser diffraction) to 5, 10, 20 minutes.
determine droplet size.
Cirrus Tandon et al Tested nebulizer using Albuterol in Measured: percentage weight change =
(1997) [46] saline with 99mTc tracer. Aerosol 57.983 %; percentage aerosol produced =
output rate was determined 36.041 %.
gravimetrically and by measuring
radioactivity.
Cirrus Barry & Illustrated the effect of breathing pattern Determined that the smaller the tidal
O’Callaghan on drug delivery. Used Novair II volume the smaller the amount of drug
(1998) [71] compressor. delivered.
Cirrus Barry & Tested nebulizer with Novair II Measured : MMD = 4.4 µm; GSD = 3.2;
O’Callaghan compressor using Salbutamol. percentage particles < 3 µm = 35% and <
(1999) [72] Measured particle size using Malvern 5 µm = 58%; output rate = 79.4 µg/minute;
MasterSizer X. total output = 663.6 µg; nebulization time
(90% output) = 9.0 minutes.
Cirrus Le Brun et al Tested nebulizer with Tobramycin. Measured: MMD (= 2.47 µm; mean output
(1999) [47] Used Sympatec HELOS (laser rate = 11.2 ± 2.0 mg/min; nebulization
diffraction) to determine particle size. time = 12 minutes.
Cirrus Di Paolo et al Tested nebulizer in a mechanical Measured: MMD = 2.91 ± 0.18 µm.
(2005) [111] ventilator circuit using Albuterol diluted
with Sodium Chloride solution. Particle
size distribution determined following
Australian-New Zealand standard,
AS/NZS 4236:1994, using Malvern
Mastersizer.
Cirrus Independent Compared the Unomedical Opti-Mist Measured MMAD; GSD; residual volume
testing by Plus and Up-Mist with Salter Labs at normal, 45° and 90° orientations;
Nelson 8900, Huson Micro Mist, Intersurgical minimum fill volume at normal, 45° and
Laboratories, Cirrus and Philips Respironics 90° orientations; non-spill volume.
Inc. [42] Sidestream. Tested nebulizers using
0.9% Saline, at 23 ± 2°C, 40-60% RH
following Australian/New Zealand
Standard 4236:1994 and US FDA
requirements, 1993. Measured particle
size using Anderson 8-stage cascade
impactor.

CEP09018: October 2009


Appendix 1: Summary of evidence 125

Table 15. Summary of in vitro performance testing of Intersurgical nebulizers (continued)


Device Author Method Results
Micro Cirrus Hurley & Smye Performance of 14 jet nebulizers was Measured: MMD = 1.04 µm; nebulization
(1994) [28] compared using 4 ml of 0.9% Saline time = 2466 seconds; percentage drug
and 10 l/min flow rate. Relevant released as aerosol = 54 %; rate of drug
nebulizers: Micro Cirrus, Respironics emission = 0.49 mg/minute.
Sidestream, Clement-Clarke Micro-Neb
III, Huson Up-Draft and Up-Draft II.
Particle size measured using Malvern
laser particle size analyser.
Micro Cirrus Smith et al Tested nebulizer with a Novair II Measured: MMAD = 7.0 µm for 2.5 ml and
(1995) [59] compressor. Used sterile water (2.5 ml 5.4 µm for 5.0 ml; percentage < 5 µm = 39
and 5.0 ml fill volumes) and Malvern % for 2.5 ml and 48 % for 5.0 ml
Master Sizer MS20 (laser diffraction) to depending on compressor used;
determine droplet size. compressor noise output; compressor
energy consumption; volume output after
5, 10, 20 minutes.
Micro Cirrus Le Brun et al Tested nebulizer with Tobramycin. Measured: MMD = 1.25 µm; mean output
(1999) [47] Used Sympatec HELOS (laser rate = 2.0 ± 1.3 mg/min; nebulization time
diffraction) to determine particle size. = 12 minutes.

Table 16. Summary of in vitro performance testing of Meditech nebulizers


Device Author Method Results
Medi-Mist Meditech Tested nebulizer at three flow rates: Measured (high, medium, low flow rates):
summary of 11.4, 7.7 and 6.7 l/minute. Solution volume output = 1.49, 1.37, 1.39 ml;
independent used was not stated. Used 2 ml fill residual volume = 0.51, 0.63, 0.61 ml;
testing [60] volume and nebulized for 10 minutes. percentage of particles < 5.3 µm = 54, 43,
Malvern 2600c laser particle size 35 %.
analyser used.

CEP09018: October 2009


Appendix 1: Summary of evidence 126

Table 17. Summary of in vitro performance testing of Omron nebulizers


Device Author Method Results
MicroAir Kaital et al Tested nebulizer with Albuterol Measured: percentage of droplets in the
(NE-U22V) (2000) [61] Sulphate and Saline. Particle size respirable range (1-5 µm) = 38 %; total
determined using PMS CSASP-100 volume output = 2.94 ml; total volume
laser particle analyser. delivered in the respirable range = 1.117
ml; respirable rate = 0.109 ml/minute;
nebulization time.
MicroAir Waldrep et al Studied different approaches to Measured (at room temperature 23°C
(NE-U22V) (2007) [62] measuring aerosol particle size. (NaF) and 4°C (NaF and Albuterol), 50%
Compared MSP next generation relative humidity): MMAD; GSD; RF < 5
pharmaceutical impactor (NGI), Thermo μm; FPF < 3.3 μm. Results showed that
Anderson cascade impactor (ACI) and NaF and Albuterol were more consistent
time-of-flight (TOF) analysis using TSI and generally equivalent when determined
3321 aerodynamic particle size by NGI (23°C and 4°C) and ACI analysis
spectrometer. Used sodium fluoride at 4°C. Aerosol particle size measured by
(NaF 2.5%) and generic Albuterol TOF in APS at both 23°C and 4°C were
(0.083%). larger than results obtained by cascade
impactor.
MicroAir Ghazanfari et al Tested the nebulizer with five different Measured: VMD ranged between 4.39-
(NE-U22V) (2008) [22] solutions: Glycerol solution; NaCl; 7.31 µm; fine particle fraction (FPF)
Ethanol; Silica Fluid; Deionised Water. ranged between 30.23-58.47 %; total
Particle size measured using Malvern aerosol output ranged between 93.52-
2600 laser diffraction analyser. 95.89 %; aerosol output rate ranged
between 0.09-1.32 ml/minute; nebulization
time ranged between 3.78-51.91 minutes.
MicroAir Johnson et al Tested the nebulizer with rhDNase. Measured: MMAD = 4.3 µm; GSD = 2.8;
(NE-U22V) (2008) [63] Particle size measured using cascade RF = 56.7 %; FPF (percentage particles <
impaction. 3.3 µm) = 40.7 %; nebulization time = 6.1
minutes.
MicroAir Poster by Compared Aeroneb Go with PARI LC Measured: MMAD = 5.2 µm; FPF (< 5.8
(NE-U22V) Simmons et al Star and Omron MicroAir. Inhaled µm) = 58 %; residual medication = 3 % of
(2008) [17] Albuterol Sulphate (2.5 mg/3 ml) dose volume (constant air draw, 0.29
collected on filter between nebulizer ml/minute flow rate), 12 % of dose volume
and Hans Rudolph breathing simulator (adult breathing pattern); respirable mass
(adult pattern). Particle size determined during adult breathing pattern = 1215 µg;
using Anderson Mk. II cascade respirable mass = 28 % by MMAD;
impactor. treatment time = 12 minutes.

CEP09018: October 2009


Appendix 1: Summary of evidence 127

Table 18. Summary of in vitro performance testing of PARI Medical nebulizers


Device Author Method Results
eFlow Lass et al (2006) Review paper comparing eFlow with LC MMD = 3.3 μm; GSD = 1.5; RF = 82%.
[64] Star. Used Glutathione Sodium
eFlow Li et al (2008) Tested nebulizer using Liposomal Measured: MMAD = 3.60 μm (mean);
[65] Amikacin Formulation (Arikace). Used GSD = 1.67 (mean); RF (< 5 μm) = 73.9 %
Anderson cascade impactor (cut-off (mean); FPF (< 3.3 μm) = 32.5 % (mean);
diameters: 9, 5.8, 4.7, 3.3, 2.1, 1.1 μm). Lipid-to-drug ratio; Amikacin retention;
mean Liposome particle diameter at each
stage (0 to 5).
eFlow PARI brochure Test results for tobramycin, Measured: MMD ranged from 3.9-4.3 µm;
shows result colistimethate sodium, TOR ranged from 0.50-0.70 g/minute; RF
from in-house ipratropiumbromide, dornase alfa, ranged from 63-73 %.
testing [67] acetylcysteine, isotonic sodium chloride
and dispensed hypertonic saline
solution.
eFlow PARI brochure Tested nebulizer using Tobramycin Measured: MMD = 3.95 µm; GSD = 1.47;
shows results (300 mg/5 ml). Particle size measured percentage RF < 4.7 µm = 71.3 %.
from conference using Anderson cascade impactor.
presentation by
Seemann et al
(2005) [68]
LC D Rau et al (2004) Used unit-dose of Albuterol Sulphate Measured: total inhaled = 15.2 %; exhaled
[69] solution, 2.5 mg base equivalent with 3 to ambient = 18.3 %; deposited in
ml fill volume. Nebulizer powered by 50 nebulizer apparatus = 62.5 %; remained in
PSI Oxygen at 8 l/min. unit-dose bottle = 4.1 %; nebulization time
= 8.4 minutes.
LC Plus Dennis (1995) Tested various nebulizer/compressor Measured (PARI Boy): MMAD = 4.90 μm;
[58] combinations: PARI LC Plus/PARI Boy, percentage particles size < 5 μm = 54.7
PARI LC Plus/PARI Master, %; total inhaled = 152.7 μl, inhaled < 5 μm
Respironics Ventstream/CR50, = 82.5 μl, inhaled > 5 μm = 69.2 μl and
Respironics Sidestream/Portaneb and waste = 62.2 μl for 60 seconds of
Intersurgical Cirrus/Pulmoaide using 1 nebulization. PARI Master: MMAD = 3.65
% Sodium Fluoride with patient μm; percentage particles size < 5 μm =
breathing simulator. Measured Particle 64.6 %; total inhaled = 228.4 μl, inhaled <
size using Malvern 2600 laser particle 5 μm = 147.5 μl, inhaled > 5 μm = 80.9 μl
sizer. and waste = 112.7 μl for 60 seconds of
nebulization. Data for 2 ml and 3 ml fill
volumes was also given.
LC Plus Coates et al Tested nebulizer with Tobramycin and Measured: particle size values not
(1998) [53] saline solution. Particle size determined reported; aerosol output = 51 mg; total
using Malvern 2600 particle sizer. output in RF = 27 mg.
LC Plus Barry & Illustrated the effect of breathing pattern Determined that the smaller the tidal
O’Callaghan on drug delivery. Used JuniorBoy volume the smaller the amount of drug
(1998) [71] compressor. delivered.
LC Plus Barry & Tested nebulizer with Turboboy Measured: MMD = 5.1 µm; GSD = 2.0;
O’Callaghan compressor using Salbutamol. percentage particles < 3 µm = 49 % and <
(1999) [72] Measured particle size using Malvern 5 µm = 22 %; output rate = 251.5
MasterSizer X. µg/minute; total output = 1085.6 µg;
nebulization time (90% output) = 6.1
minutes.
LC Plus Le Brun et al Tested nebulizer with Tobramycin using Measured: MMD = 2.06 µm; mean output
(1999) [47] PARI Boy compressor. Used Sympatec rate = 33.2 ± 5.1 mg/min; nebulization
HELOS (laser diffraction) to determine time = 6 minutes.
particle size.

CEP09018: October 2009


Appendix 1: Summary of evidence 128

Table 18. Summary of in vitro performance testing of PARI Medical nebulizers (continued)
Device Author Method Results
LC Plus Barry & Tested nebulizer with Budesonide using Measured: MMAD = 4.1 µm; GSD = 2.1;
O’Callaghan Turboboy compressor. Measure particle output rate in the first minute, after 15
(1999) [73] size using a glass multistage liquid minutes; time for 90 % output; percentage
impinger. drug delivered with particle size < 6.1 µm.
LC Plus Standaert et al Tested nebulizer with Tobramycin using Measured: MMD ranged between 3.57-
(2000) [74] eight different compressors: Hercules; 5.42 µm; GSD; respirable mass fraction
CR50; CR60; ST23; ST26; Master; Boy; (1-5 µm) ranged between 52.4-153.0 mg;
PulmoAide. Used Malvern Mastersizer nebulization time ranged between 7.9-
X (laser diffraction) to determine particle 20.9 minutes; residual volume ranged
size. between 1.6-2.4 ml.
LC Plus Veceillio None et Tested nebulizer to EN13544-1 using Measured MMAD and GSD for each
al (2001) [75] NaF. Also looked at the different method. A-MPCI: MMAD = 4.53 ± 0.25
methods of determining particle size µm; GSD = 2.49 ± 0.08. MasterSizer-X:
using Anderson cascade impactor (A- MMAD = 4.46 ± 0.19 µm; GSD = 2.29 ±
MPCI); MasterSizer-X; APS 3310; GSI 0.04. APS: MMAD = 4.45 ± 0.28 µm; GSD
cascade impactor. = 2.38 ± 0.03. GSI: MMAD = 4.27 ± 0.26
µm; GSD = 2.20 ± 0.15. The paper
concluded that the MAsterSizer-X was
suitable alternative for characterising
nebulizers in the context of the European
Standard.
LC Plus Asmus et al Tested nebulizer with Tobramycin. Measured: MMAD = 2.31 µm; percentage
(2001) [76] Measured particle size distribution of particles in the respirable range = 60.6
using Anderson cascade impactor. %; output rate = 0.64 ml/minute.
LC Plus Dennis & Pieron Tested nebulizer using BS7711 and Measured (shown at 6.5 l/minute): MMD =
(2002) [77] EN13544-1methodologies. Used 3.98 µm; percentage aerosol < 2 µm =
Tobramycin and NaCl solution at five 22.6 % and < 5 µm = 64.0 %; percentage
different flow rates: 2.6, 3.6, 4.6, 5.4 aerosol between 2-5 µm = 41.2 %; aerosol
and 6.5 l/minute. Used cascade output after 1 minute = 496 µl and 15
impactor with BS methodology and minutes = 3050 µl; total aerosol output =
laser diffraction with EN. 3050 µl; nebulization time = 6 minutes 28
seconds.
LC Plus de Boar et al Tested nebulizer using five different Measured: MMD = 1.84 µm (CR60), 2.63-
(2003) [78] compressors: CR60, Porta-neb, Pulmo- 3.72 µm (Freeway Freedom).
abstract only aide, Turboboy and Freeway Freedom
using Tobramycin solution. Particle size
determined using laser diffraction
technique.
LC Plus Rüdiger et al Tested nebulizer at 4.1 l/minute flow Measured: MMD ranged between 5.09-
(2004) [79] rate with four different Perflurocarbons. 13.03 µm; aerosolisation rate ranged
Partcile size measured using Malvern between 0.48-1.48 ml/minute.
Mastersizer 2601C (laser diffraction).
LC Plus Zhou et al (2005) Tested nebulizer with Albuterol and Measured: Albuterol at 22°C: MMAD =
[40] Budesonide solution at 10 and 22°C. 2.85 µm; GSD = 2.50; RF = 36.47 %.
Measured particle size using Anderson Albuterol at 10°C: MMAD = 3.56 µm; GSD
8-stage cascade impactor. = 2.13; RF = 32.72 %. Budesonide at
22°C: MMAD = 5.21 µm; GSD = 1.97; RF
= 20.81 %. Budesonide at 10°C: MMAD =
5.61 µm; GSD = 1.91; RF = 14.89 %.
LC Plus PARI brochure Tested nebulizer suing Tobramycin Measured: MMD = 3.50 µm; GSD = 2.10;
shows results (300 mg/5 ml). Particle size measured percentage RF < 4.7 µm = 70.1 %.
from conference using Anderson cascade impactor.
presentation by
Seemann et al
(2005) [68]

CEP09018: October 2009


Appendix 1: Summary of evidence 129

Table 18. Summary of in vitro performance testing of PARI Medical nebulizers (continued)
Device Author Method Results
LC Plus Berlinski & Tested nebulizer with Albuterol and five Measured: MMAD ranged between 2.52-
Waldrep (2006) different admistures: Albuterol; 3.40 µm; GSD ranged between 2.16-2.42;
[48] Albuterol combined with Ipratopium RF (0.4-5.0 µm) ranged between 67-77 %;
Bromide; Albuterol combined with total drug output = 1.3-1.9 ml.
Cromolyn Sodium; Albuterol combined
with Tobramycin; Albuterol combined
with N-acetylcysteine; Albuterol
combined with Flunisolide at 8 l/minute
flow rate. Particle size distribution
determined using Anderson cascade
impactor.
LC Plus Majoral et al Paper compares different methods of Measured (EN13544-1): MMAD (± SD) =
(2006) [15] processing data collected from cascade 4.0 ± 0.6 µm; RF (± SD) = 57 ± 6 %. Log-
impactor measurements: EN13544-1; normal: MMAD (± SD) = 5.1 ± 0.4 µm; RF
Log-normal; Calibration matrix. Tested (± SD) = 48 ± 5 %. Calibration matrix:
nebulizer using TurboBoy N MMAD (± SD) = 5.1 ± 0.9 µm; RF (± SD) =
compressor with NaF. Used 8-stage 46 ± 6 %.
Marple model 298 cascade impactor.
LC Plus Leung et al Used tgAAVCF solution (Adeno- MMD = 2.78 ± 0.43 μm; 47% of initial
(2007) [80] associated virus vector) and albuterol dose; 72.00 ± 0.73% delivered beyond
as a comparison. Determined particle vocal cords. Albuterol MMD = 3.66 μm
size distribution (PSD) using laser (laser) and 3.11 μm (NGI).
diffraction and inertial impaction
(Malvern next generation impactor,
NGI)
LC Plus Majoral et al Tested nebulizer using a Turbo Boy N Measured: VMD = 3.6 µm; RF ranged
(2007) [81] compressor with Ipratopium Bromide between 54-56 %; inhaled mass;
and Ipratopium Bromide with nebulization time ranged between 1.1-8.4
Terbutaline. Measurement of inhaled minutes.
mass was performed using EN13544-1
methodology. Particle size measured
using Malvern Mastersizer X (laser
diffraction).
LC Plus Terzano et al Tested nebulizer using Turbo Boy Measured: MMAD: Beclomethasone =
(2007) [82] compressor with Beclomethasone 3.34 ± 0.50 µm; Flunisolide = 4.89 ± 2.70
Dipropinate, Flunisolide, Fluticasone µm; Fluticasone = 2.29 ± 0.10 µm;
Propronate and Budesonide. Particle Budesonide = 2.17 ± 0.20 µm; % particles
size measured using API Aerosizer < 5 and 2 µm; nebulization time ranged
Mach 2 time-of-flight beam between 10.3-12.5 minutes; drug output
spectrometer. per minute.
LC Plus Dennis et al Compared test results from five Measured (average): MMAD = 3.23 µm
(2008) [16] different laboratories for three types of (ambient), 3.64 µm (cool); GSD = 2.41
nebulizers (Aeroneb Go: vibrating (ambient), 2.33 (cool); FDF (fine droplet
mesh; PARI LC Plus: breath enhanced; fraction) = 69.1 % (ambient), 64.7 %
Misty Max: constant output jet) using a (cool). Found that the cooled NDI yielded
pre-cooled (5°C for 90 minutes) NGI a coarser nebulized aerosol. MMAD was
and an ambient temperature NGI. reduced by 9.5-21.9 %. Variability was
Salbutamol solution (5 mg/2 ml). similar for both cooled and ambient NGI.
LC Plus Akapo et al Used admixtures: Formoterol Formulate Measured: MMAD ranged from 2.9-5.3
(2008) [83] (20 μg/2 ml) mixed or sequentially µm; GSD ranged from 1.7-2.2; RF ranged
nebulized with Budesonide inhalation from 18.1-48.0 %; fine particle dose, FPD
suspension (0.5 mg/2 ml); Ipratropium (μg or mg); fine particle fraction, FPF
Bromide (0.5 mg/2 ml); Cromolyn ranged from 43.5-74.8 %; delivered dose
Sodium (20 mg/2 ml); Acetylcysteine by estimated dose chamber, EDC ranged
10% (100 mg/ ml). Particle size from 35.1-60.0 % label claim.
measured using Anderson cascade
impactor.

CEP09018: October 2009


Appendix 1: Summary of evidence 130

Table 18. Summary of in vitro performance testing of PARI Medical nebulizers (continued)
Device Author Method Results
LC Plus Johnson et al Tested the nebulizer with rhDNase. Measured: MMAD = 4.2 µm; GSD = 2.7;
(2008) [63] Particle size measured using cascade RF = 56.3 %; FPF (percentage particles <
impaction. 3.3 µm) = 44.0 %; nebulization time = 7.2
minutes.
LC Plus Poster by Compared Aeroneb Go with PARI LC Measured: MMAD = 1.7 µm; FPF (< 5.8
Simmons et al Star and Omron MicroAir. Inhaled µm) = 58 %; residual medication = 3 % of
(2008) [17] Albuterol Sulphate (2.5 mg/3 ml) dose volume (constant air draw, 0.29
collected on filter between nebulizer ml/minute flow rate), 12 % of dose volume
and Hans Rudolph breathing simulator (adult breathing pattern); respirable mass
(adult pattern). Particle size determined during adult breathing pattern = 1215 µg;
using Anderson Mk. II cascade respirable mass = 28 % by MMAD;
impactor. treatment time = 12 minutes.
LC Plus Independent Flaem Nuova RF6 Plus testing to EN TÜV certificate and results data of in-vitro
testing by 13544-1: 2001 by Inamed which also characterisation of particle size and output
Inamed shows LC Plus test data
Research GmbH
& Co. KG [35]
LC Plus In-house test E-mail from PARI showing test results Measured: MMD ranged from 3.0-3.5 µm;
summary [67] when using Salbutamol, DSCG, TOR ranged from 481-579 mg/minute;
Ipratrop and Budesonide with PARI Boy RDDR < 5 µm ranged from 17.1-1210
SX compressor. Used adult breathing µg/minute; relative RDDR < 5 µm ranged
pattern (15 breaths/minute; 500 ml tidal from 3.52-6.17 %/minute.
volume; 50/50 inhalation/exhalation
ratio).
LC Plus Internal Tested Sidestream, PARI LC Plus and Measured (Albuterol, Ipratropium,
Respironics Salter 8900 using an Elite compressor Budesonide): MMAD = 3.1, 2.6, 2.9 µm;
report [85] with Albuterol (2.5 mg, 3 ml), RF = 65.7, 68.7, 72.0 %; delivery rate =
Ipratropium Bromide (0.5 mg, 2.5 ml) 159.9, 53.7, 52.8 µg/minute.
and Budesonide (0.5 mg, 2 ml). Particle
size measured using In-Tox cascade
impactor.
LC Plus Conference Compared the performance of five Measured: MMD = 4.7 µm; RF
presentation nebulizers: PARI LC Star and LC Plus; (percentage of aerosol in 1-5 µm range) =
abstract by Philips Respironics Sidestream and 41 %; output = 0.18 ml/minute;
Geller & Ventstream; Hudson Updraft. Used nebulization time = 19.0 minutes;
Standaert (1997) Colistimethate (Colymycin) 150 mg percentage delivered = 32 %.
[49] dissolved in 4 cc H2O.
LC Sprint In-house test E-mail from PARI showing test results Measured: PARI BOY SX: MMD ranged
summary [67] when using Salbutamol, DSCG, from 2.8-3.5 µm; TOR ranged from 593-
Ipratrop and Budesonide with two 673 mg/minute; RDDR < 5 µm ranged
different compressors: PARI BOY SX from 41.6-1570 µg/minute; relative RDDR
and PARI TurboBOY S compressor. < 5 µm ranged from 4.13-7.12 %/minute.
Used adult breathing pattern (15 PARI TurboBOY S: MMD ranged from 3.4-
breaths/minute; 500 ml tidal volume; 4.0 µm; TOR ranged from 499-593
50/50 inhalation/exhalation ratio). mg/minute; RDDR < 5 µm ranged from
17.2-1210 µg/minute; relative RDDR < 5
µm ranged from 3.51-6.23 %/minute.
LC Sprint In-house test E-mail from PARI showing test results Measured: MMD ranged from 1.9-2.2 µm;
Baby summary [67] when using Salbutamol, DSCG, TOR ranged from 174-193 mg/minute;
Ipratrop and Budesonide with PARI RDDR < 5 µm ranged from 4.8-650
BOY SX compressor. Used 3 year old µg/minute; relative RDDR < 5 µm ranged
child breathing pattern (24 from 0.99-3.20 %/minute.
breaths/minute; 125 ml tidal volume;
40/60 inhalation/exhalation ratio).

CEP09018: October 2009


Appendix 1: Summary of evidence 131

Table 18. Summary of in vitro performance testing of PARI Medical nebulizers (continued)
Device Author Method Results
LC Sprint In-house test E-mail from PARI showing test results Measured: MMD ranged from 2.9-3.2 µm;
Junior summary [67] using Salbutamol, DSCG, Ipratrop and TOR ranged from 284-342 mg/minute;
Budesonide with PARI juniorBOY S RDDR < 5 µm ranged from 8-660
compressor. Used 10 yr old child µg/minute; relative RDDR < 5 µm ranged
breathing pattern (16 breaths/min; 225 from 1.63-3.25 %/minute.
ml tidal volume; 40/60
inhalation/exhalation ratio).
LC Sprint Star In-house test E-mail from PARI showing test results Measured: MMD ranged from 2.14-2.3;
summary [67] when using Salbutamol, DSCG, TOR ranged from 407-490 mg/minute;
Ipratrop and Budesonide with PARI RDDR < 5 µm ranged from 12.2-1440
BOY SX compressor. Used adult µg/minute; relative RDDR < 5 µm ranged
breathing pattern (15 breaths/minute; from 2.54-7.12 %/minute.
500 ml tidal volume; 50/50
inhalation/exhalation ratio).

Table 19. Summary of in vitro performance testing of Philips Respironics nebulizers


Device Author Method Results
Medel PARI Medical in- E-mail from PARI showing test results Measured: MMD ranged from 3.5-3.8 µm;
MedelJet Pro house test when using Salbutamol, DSCG, TOR ranged from 433-488 mg/minute;
summary [86] Ipratrop and Budesonide with Medel RDDR < 5 µm ranged from 12.9-860
Pro compressor. Used adult breathing µg/minute; relative RDDR < 5 µm ranged
pattern (15 breaths/minute; 500 ml tidal from 2.62-4.48 %/minute.
volume; 50/50 inhalation/exhalation
ratio).
Sidestream Hurley et al Tested nebulizer using Maxi III Measured (Amphotericin; Colomycin;
(1994) [27] compressor at 101 l/min with four Tobramycin; Gentamicin): MMD = 2.18,
different antibiotics: Amphotericin; 2.14, 2.20, 2.19 µm; respirable fraction,
Colomycin; Tobramycin; Gentamicin RF (< 5.17 µm) = 92, 92, 90, 92 %;
and five fill volumes: 2, 3, 4, 5, 6 ml. percentage mass released as aerosol
Particle size measured with Malvern (shown graphically); nebulization time
Instruments Mastersizer laser particle ranging from 193-762 seconds depending
size analyser. on fill volume and drug.
Sidestream Loffert et al Tested nebulizer with Albuterol (0.5 ml Measured: total volume output = 1.86 ml;
(1994) [51] + 2 ml saline) using DeVilBiss time of total output = 7.14 minutes;
Pulmoaide 5610D compressor. PMS percentage of particles in respirable range
CSASP-100 laser diffractometry particle (1-5 μm) = 71.95 %; respirable rate =
size analyser used. 0.1905 ml/minute.
Sidestream Hurley & Smye Performance of 14 jet nebulizers was Measured: MMD = 2.13 µm; nebulization
(1994) [28] compared using 4 ml of 0.9% Saline time = 561 seconds; percentage drug
and 10 l/min flow rate. Relevant released as aerosol = 67 %; rate of drug
nebulizers: Micro Cirrus, Respironics emission = 4.08 mg/minute.
Sidestream, Clement-Clarke Micro-Neb
III, Huson Up-Draft and Up-Draft II.
Particle size measured using Malvern
laser particle size analyser.
Sidestream Dennis (1995) Tested various nebulizer/compressor Measured: MMAD = 2.66 μm; percentage
[58] combinations: PARI LC Plus/PARI Boy, particles size < 5 μm = 83.4 %; total
PARI LC Plus/PARI Master, inhaled = 104.7 μl, inhaled < 5 μm = 87.3
Respironics Ventstream/CR50, μl, inhaled > 5 μm = 17.4 μl and waste =
Respironics Sidestream/Portaneb and 187.0 μl for 60 seconds of nebulization.
Intersurgical Cirrus/Pulmoaide using 1 Data for 2 ml and 3 ml fill volumes was
% Sodium Fluoride with patient also given.
breathing simulator. Measured Particle
size using Malvern 2600 laser particle
sizer.

CEP09018: October 2009


Appendix 1: Summary of evidence 132

Table 19. Summary of in vitro performance testing of Philips Respironics nebulizers (continued)
Device Author Method Results
Sidestream Hess et al (1996) Tested nebulizer using Albuterol and Measured (data represented graphically):
[36] saline solution. Measured particle size MMAD; GSD; respirable mass; inhaled
using 11-stage cascade impactor at 3 mass; dead volume; nebulization time.
different flow rates.
Sidestream Conference Meeting presentation summary. Used Measured: MMAD = 2.1 µm; delivery time
presentation Sidestream/Mobilaire and Hudson Up- = 1.3-2.0 minutes.
summary by Draft/Pulmo-aide nebulizer/compressor
Geller et al with Dornase Alfa (rhDNase) in clinical
(1996) [50] trail on 749 cystic fibrosis patients
Sidestream Conference Compared the performance of five Measured: MMD = 2.5 µm; RF
presentation nebulizers: PARI LC Star and LC Plus; (percentage of aerosol in 1-5 µm range) =
abstract by Philips Respironics Sidestream and 66 %; output = 0.23 ml/minute;
Geller & Ventstream; Hudson Updraft. Used nebulization time = 12.9 minutes;
Standaert (1997) Colistimethate (Colymycin) 150 mg percentage delivered = 52 %.
[49] dissolved in 4 cc H2O.
Sidestream Shah et al Tested nebulizer with rhDNase using Measured: MMAD = 3.42 µm; percentage
(1997) [52] CR 50 compressor. Measured particle of aerosol by mass in the respirable range
size using Malvern 2600 laser particle (1.0-5.6 µm), RF = 71 %; aerosol output =
analyser. 33 %; nebulization time; nebulizer
efficiency (ratio of dry weight to respirable
output).
Sidestream Weber et al Tested nebulizer using: saline (0.9 % Measured: MMAD (shown graphically);
(1997) [32] w/w Sodium Chloride in distilled water); aerosol output rate (Saline) = 0.24
Gentamicin; Tobramycin Sulphate; ml/minute (PulmoAide), 0.32 ml/minute
Ceftazidime Sodium salt; Ciprofloxacin; (PARI Master); RF (percentage particle
Colistimethate Sodium. Used two between 1-5 µm ranged from 76-85 %.
differenent compressors: Pulmo-Aide Also given are osmolality, viscosity, pH
and PARI Master. Used Malvern and surface tension for antibiotic aerosol
Mastersizer (laser) to determine particle solutions.
size.
Sidestream Barry & Illustrated the effect of breathing pattern Determined that the smaller the tidal
O’Callaghan on drug delivery. Used Portaneb 50 volume the smaller the amount of drug
(1998) [71] compressor. delivered.
Sidestream Barry & Tested nebulizer with Portaneb Measured: MMD = 3.9 µm; GSD = 1.9;
O’Callaghan compressor using Salbutamol. percentage particles < 3 µm = 69 % and <
(1999) [72] Measured particle size using Malvern 5 µm = 33 %; output rate = 157.0
MasterSizer X. µg/minute; total output = 1051.1 µg;
nebulization time (90% output) = 8.2
minutes.
Sidestream Bendstrup et al Tested the nebulizer with three Heparin Measured: MMD ranged between 2.01 ±
(1999) [87] formulations: Sodium Heparin; Calcium 0.02 µm and 3.64 ± 0.04 µm; GSD ranged
Heparin; low molecular weight Heparin between 1.86 ± 0.01 and 2.75 ± 0.12; %
(Tinzaparin) using different flow rates particles < 3 µm ranged between 41-74 %
and temperatures. Measured particle due to increasing Heaprin concentrations
size using Malvern MasterSizer X. and flow rate; aerosol output rate.
Sidestream Le Brun et al Tested nebulizer with Tobramycin. Measured: MMD = 2.06 µm; Porta-Neb:
(1999) [47] Used Porta-Neb, Pulmo-Aide and mean output rate = 25.1 ± 8.5 mg/min;
Freeway Lite compressors. Used nebulization time = 6 minutes. Pulmo-
Sympatec HELOS (laser diffraction) to Aide: mean output rate = 9.1 ± 0.7
determine particle size. mg/min; nebulization time = 12 minutes.
Freeway: MMD = 1.76 µm mean output
rate = 15.7 ± 3.7 mg/min; nebulization
time = 9 minutes.

CEP09018: October 2009


Appendix 1: Summary of evidence 133

Table 19. Summary of in vitro performance testing of Philips Respironics nebulizers (continued)
Device Author Method Results
Sidestream O’Riordan et al Tested nebulizer with 3 ml Albuterol + Measured: MMAD = 1.5 μm
(1999) [88] 99mTc tracer. Measured particle size (spontaneous), 1.2 μm (ventilation); GSD
using 10-stage cascade impactor for = 2.2 (spontaneous), 2.0 (ventilation).
spontaneous breathing and during
mechanical ventilation.
Sidestream Rau et al (2004) Used unit-dose of Albuterol Sulphate Measured: total inhaled = 15.8 %; exhaled
[69] solution, 2.5 mg base equivalent with 3 to ambient = 17.3 %; deposited in
ml fill volume. Nebulizer powered by 50 nebulizer apparatus = 63.4 %; remained in
PSI Oxygen at 8 l/min. unit-dose bottle = 3.6 %; nebulization time
= 9.5 minutes.
Sidestream Reychler et al Compared standard jet nebulization Measured: MMAD = 1.89 μm (SST), 0.20
(2004) [89] (SST) to intrapulmonary percussive μm (IPV); FPF = 67.5 % (SST), 16.2 %
ventilation (IPV). Used 2 ml (IPV); output flow = 10.3 l/minute (SST),
Sulforhodamine solution. Nebulized 70.6 l/minute (IPV).
during 1 minute, 28.3 l/min inspiratory
flow rate. Nebulizer driven using 3.5
bars compressed air. Particle size
measured using 8-stage ACFM
cascade impactor at 23°C.
Sidestream Zhou et al (2005) Tested nebulizer with Albuterol solution Measured: 22°C: MMAD = 1.36 µm; GSD
[40] at 10 and 22°C. Measured particle size = 1.80; RF = 34.50 %. 10°C: MMAD =
using Anderson 8-stage cascade 2.83 µm; GSD = 1.78; RF = 28.47 %.
impactor.
Sidestream Wong-Beringer Tested nebulizer with Envoy Measured: RF = 44% for 10 mg/ml and
et al (2005) [39] compressor using Caspofungin 0.9% 57% for 30 mg/ml; output rate (shown
NaCl at two concentrations: 10 mg/ml graphically).
and 30 mg/ml. Particle size determined
using API Aerosizer time-of-flight aersol
spectrometer.
Sidestream Majoral et al Paper compares different methods of Measured: EN13544-1: MMAD (± SD) =
(2006) [15] processing data collected from cascade 3.0 ± 0.4 µm; RF (± SD) = 70 ± 4 %. Log-
impactor measurements: EN13544-1; normal: MMAD (± SD) = 3.4 ± 0.4 µm; RF
Log-normal; Calibration matrix. Tested (± SD) = 67 ± 7 %. Calibration matrix:
nebulizer using Freeway compressor MMAD (± SD) = 3.4 ± 0.4 µm; RF (± SD) =
with NaF. Used 8-stage Marple model 65 ± 8 %.
298 cascade impactor.
Sidestream Majoral et al Tested nebulizer using a Turbo Boy N Measured: VMD = 3.4-3.6 µm; RF ranged
(2007) [81] compressor with Ipratopium Bromide between 67-68 %; inhaled mass;
and Ipratopium Bromide with nebulization time ranged between 2.3-9.5
Terbutaline. Measurement of inhaled minutes.
mass was performed using EN13544-1
methodology. Particle size measured
using Malvern Mastersizer X (laser
diffraction).
Sidestream Terzano et al Tested nebulizer using Maxaer Measured: MMAD: Beclomethasone =
(2007) [82] compressor with Beclomethasone 2.46 ± 0.20 µm; Flunisolide = 2.27 ± 0.50
Dipropinate, Flunisolide, Fluticasone µm; Fluticasone = 1.87 ± 0.30 µm;
Propronate and Budesonide. Particle Budesonide = 1.52 ± 0.10 µm; % particles
size measured using API Aerosizer < 5 and 2 µm; mass of drug output;
Mach 2 time-of-flight beam nebulization time ranged between 4.1-5.6
spectrometer. minutes.
Sidestream Internal Tested Sidestream, PARI LC Plus and Measured (Albuterol, Ipratropium,
Respironics Salter 8900 using an Elite compressor Budesonide): MMAD = 2.6, 2.5, 2.5 µm;
report [85] with Albuterol (2.5 mg, 3 ml), RF = 74.7, 72.0, 77.0 %; delivery rate =
Ipratropium Bromide (0.5 mg, 2.5 ml) 170.4, 44.7, 46.6 µg/minute.
and Budesonide (0.5 mg, 2 ml). Particle
size measured using In-Tox cascade
impactor.

CEP09018: October 2009


Appendix 1: Summary of evidence 134

Table 19. Summary of in vitro performance testing of Philips Respironics nebulizers (continued)
Device Author Method Results
Sidestream Independent Compared the Unomedical Opti-Mist Measured MMAD; GSD; residual volume
testing by Plus and Up-Mist with Salter Labs at normal, 45° and 90° orientations;
Nelson 8900, Huson Micro Mist, Intersurgical minimum fill volume at normal, 45° and
Laboratories, Cirrus and Philips Respironics 90° orientations; non-spill volume.
Inc. [42] Sidestream. Tested nebulizers using
0.9% Saline, at 23 ± 2°C, 40-60% RH
following Australian/New Zealand
Standard 4236:1994 and US FDA
requirements, 1993. Measured particle
size using Anderson 8-stage cascade
impactor.
Ventstream Dennis (1995) Tested various nebulizer/compressor Measured: MMAD = 3.11 μm; percentage
[58] combinations: PARI LC Plus/PARI Boy, particles size < 5 μm = 73.6 %; total
PARI LC Plus/PARI Master, inhaled = 99.5 μl, inhaled < 5 μm = 71.4
Respironics Ventstream/CR50, μl, inhaled > 5 μm = 28.1 μl and waste =
Respironics Sidestream/Portaneb and 26.0 μl for 60 seconds of nebulization.
Intersurgical Cirrus/Pulmoaide using 1 Data for 2 ml and 3 ml fill volumes was
% Sodium Fluoride with patient also given.
breathing simulator. Measured Particle
size using Malvern 2600 laser particle
sizer.
Ventstream Hess et al (1996) Tested nebulizer using Albuterol and Measured (data represented graphically):
[36] saline solution. Measured particle size MMAD; GSD; respirable mass; inhaled
using 11-stage cascade impactor at 3 mass; dead volume; nebulization time.
different flow rates.
Ventstream Devadason et al Tested nebulizer using 2.5 ml of Measured: MMAD = 3.57 (SD 0.07) µm,
(1997) [90] Salbutamol (1.0 mg/ml). Used Malvern span 1.44 (SD 0.03); aerosol output mean
Mastersizer X laser particle sizer to % = 19.02 (SD 5.78); time taken for
determined particle size distribution. cessation of output; mean amount of drug
Aerosol output determined in a clinical retained.
trial of cystic fibrosis patients.
Ventstream Conference Compared the performance of five Measured: MMD = 3.0 µm; RF
presentation nebulizers: PARI LC Star and LC Plus; (percentage of aerosol in 1-5 µm range) =
abstract by Philips Respironics Sidestream and 64 %; output = 0.22 ml/minute;
Geller & Ventstream; Hudson Updraft. Used nebulization time = 14.7 minutes;
Standaert (1997) Colistimethate (Colymycin) 150 mg percentage delivered = 50 %.
[49] dissolved in 4 cc H2O.
Ventstream Barry and Tested nebulizer with Portaneb Measured: MMD = 3.8 µm; GSD = 2.1;
O’Callaghan compressor using Salbutamol. percentage particles < 3 µm = 71 % and <
(1999) [72] Measured particle size using Malvern 5 µm = 37 %; output rate = 156.7
MasterSizer X. µg/minute; total output = 950.0 µg;
nebulization time (90% output) = 7.3
minutes.
Ventstream Barry and Tested nebulizer with Budesonide using Measured: MMAD = 3.1 µm; GSD = 2.0;
O’Callaghan Portaneb compressor. Measure particle output rate in the first minute, after 15
(1999) [73] size using a glass multistage liquid minutes; time for 90% output; percentage
impinger. drug delivered with particle size < 6.1 µm.
Ventstream Le Brun et al Tested nebulizer with Tobramycin using Measured: MMD = 2.11 µm; mean output
(1999) [47] Porta-Neb compressor. Used cascade rate = 39.3 ± 4.3 mg/min; nebulization
impactor and Sympatec HELOS (laser time = 6 minutes.
diffraction) to determine particle size.
Ventstream Münster et al Tested nebulizer with Lyophilized Measured: MMD = 2.96 µm (10 l/minute, 5
(2000) [91] recombinant suc-PA. Particle size mg/ml); GSD = 1.91: percentage particles
determined using Malvern Mastersizer < 3 µm = 50.91; median nebulization time
X (laser diffraction). Range of flow rates for 20 mg = 8.45 minutes.
and drug concentration used.

CEP09018: October 2009


Appendix 1: Summary of evidence 135

Table 19. Summary of in vitro performance testing of Philips Respironics nebulizers (continued)
Device Author Method Results
Ventstream Ho et al (2001) Tested nebulizer with 2.5 mg (0.5 ml) Measured: MMD (shown graphically);
[92] Albuterol + 3.5 ml 0.9% saline. Used respirable fraction (shown graphically);
Malvern Mastersizer-X to measure total output = 1.47 mg; output rate = 0.15
particle size (laser diffraction mg/minute; residual volume = 1.07 ml.
technique).
Ventstream Summary of Compared Flaem Nuova RF5 Plus Measured: MMAD = 2.4 µm (F2000), 2.6
independent (used F2000, F1000 and F400 µm (F1000); GSD = 2.13 (F2000), 2.02
testing by compressor), RF6 Plus (used F2000 (F1000); FPF = 84 % (F2000), 82 %
Inamed and F1000 compressor), RF6 Basic (F1000); output rate = 65 µl/minute
Research GmbH (used F400 compressor), PARI LC Plus (F2000), 59 µl/minute (F1000); total output
& Co. KG. for (used F2000 and F1000 compressor) = 252 µl (F2000), 253 µl (F1000); residual
Flaem Nuova and Respironics Ventstream (used volume = 1.40 ml (F2000), 1.47 ml
[33] F2000 and F1000 compressor). Tested (F1000).
nebulizers to EN 13544-1. Used 8-
stage Anderson Mk II cascade impactor
to determine particle size.
Ventstream Independent States testing to EN 13544-1: 2001. TÜV certificate and results data (shown
testing by Flaem Nuova independent testing graphically) of in-vitro characterisation of
Inamed showing data for the Ventstream. particle size and output
Research GmbH
& Co. KG. for
Flaem Nuova
[35]
Ventstream Astra Zeneka The nebulizer was tested with Measured: Passport: MMAD = 2.6 µm;
sponsored Budesonide suspension (1.0mg in 2 ml) GSD = 2.0; RF ≤ 6 µm = 87 %; RF ≤ 3.5
poster by using a Harvard sinus pump which µm = 68 %; inhaled mass = 139 µg;
Nikander et al generated a simulated breathing exhaled mass = 38 µg. PulmoAide: MMAD
[93] pattern. Both Passport and Pulmo-Aide = 2.5 µm; GSD = 1.8; RF ≤ 6 µm = 91 %;
compressors were used. RF ≤ 3.5 µm = 77 %; inhaled mass = 136
µg; exhaled mass = 43 µg. Results for
percentage of inhaled dose are shown on
a plot along with 27 other
nebulizer/compressor combinations.

Table 20. Summary of in vitro performance testing of Salter Labs nebulizers


Device Author Method Results
8900 Loffert et al Tested nebulizer with Albuterol (0.5 ml Measured: total volume output = 1.23 ml;
(1994) [51] + 2 ml saline) using DeVilBiss time of total output = 6.92 minutes;
Pulmoaide 5610D compressor. PMS percentage of particles in respirable range
CSASP-100 laser diffractometry particle (1-5 μm) = 35.84 %; respirable rate =
size analyser used. 0.0642 ml/minute.
8900 Hess et al (1996) Tested nebulizer using Albuterol and Measured (data represented graphically):
[36] saline solution. Measured particle size MMAD; GSD; respirable mass; inhaled
using 11-stage cascade impactor at 3 mass; dead volume; nebulization time.
different flow rates.
8900 Reisner et al Tested nebulizer with Saline and Measured (shown at 5 l/minute): volume
(2001) [38] Albuterol at four different flow rates: 2, median diameter (VMD) = 0.77; GSD =
3, 4 and 5 l/minute. Used PMS CSASP- 2.17; percentage particles in respirable
100 laser particle size analyser to range (1-5 µm) = 55 %; nebulized volume
determined droplet size. = 1.659 ml; total volume delivered in
respirable range = 0.91 ml; respirable rate
= 0.1259 ml/minute; time taken for
nebulization = 435 seconds.

CEP09018: October 2009


Appendix 1: Summary of evidence 136

Table 20. Summary of in vitro performance testing of Salter Labs nebulizers (continued)
Device Author Method Results
8900 Internal Tested Sidestream, PARI LC Plus and Measured (Albuterol, Ipratropium,
Respironics Salter 8900 using an Elite compressor Budesonide): MMAD = 3.1, 2.7, 3.0 µm;
report [85] with Albuterol (2.5 mg, 3 ml), RF = 65.0, 60.3, 68.0 %; delivery rate =
Ipratropium Bromide (0.5 mg, 2.5 ml) 90.8, 27.9, 20.5 µg/minute.
and Budesonide (0.5 mg, 2 ml). Particle
size measured using In-Tox cascade
impactor.
8900 Cardinal Health Compared the Misty Max 10 with the Measured: MMAD = 1.85 µm; GSD =
in-house test Westmed VixOne, Hudson Micro Mist 2.58; RF (< 4.7 µm) = 73.4 %; output rate;
report [24] and Salter 8900. Used Albuterol treatment time = 7.9 minutes; residual
Sulphate. Particle size measured using volume = 1374 µg; inhaled respirable
Anderson 8-stage cascade impactor. mass = 298 µg.
8900 Independent Compared the Unomedical Opti-Mist Measured MMAD; GSD; residual volume
testing by Plus and Up-Mist with 8900, Huson at normal, 45° and 90° orientations;
Nelson Micro Mist, Intersurgical Cirrus and minimum fill volume at normal, 45° and
Laboratories, Philips Respironics Sidestream. Used 90° orientations; non-spill volume.
Inc. [42] 0.9% Saline, following Australian/New
Zealand Standard 4236:1994. Used
Anderson 8-stage cascade impactor.
8900 Loffert et al Tested nebulizer with Albuterol (0.5 ml Measured: total volume output = 1.23 ml;
(1994) [51] + 2 ml saline) using DeVilBiss time of total output = 6.92 minutes;
Pulmoaide 5610D compressor. PMS percentage of particles in respirable range
CSASP-100 laser diffractometry particle (1-5 μm) = 35.84 %; respirable rate =
size analyser used. 0.0642 ml/minute.
8900 Hess et al (1996) Tested nebulizer using Albuterol and Measured (data represented graphically):
[36] saline solution. Measured particle size MMAD; GSD; respirable mass; inhaled
using 11-stage cascade impactor at 3 mass; dead volume; nebulization time.
different flow rates.

Table 21. Summary of in vitro performance testing of Schill nebulizers


Device Author Method Results
Multisonic Summary of Drug/solution not stated. Effect of flow Measured: MMAD ranged from 3.4-4.0
infraControl independent rate was tested. Particle size measured µm; GSD ranged from 1.7-2.2.
testing by with CI or laser diffraction was not
Gessler & stated.
Schmehl (2002)
[94]
Multisonic Independent test Tested nebulizer using EN13544-1: Mesured nebulization time = 3 minutes 8
infraControl report by Inamed 2002 methodology using Ventalus (10 seconds.
Research GmbH µg Iloprost).
& Co. KG (2004)
[95]
Multisonic Summary of States that performance was Measured: MMAD = 3.9 µm; inhaled mass
infraControl independent determined in accordance with EN < 3 µm, < 2 µm, < 5 µm = 34 %, 71 %, 32
testing by Diot et 13544-1. Drug/solution used not stated. %; aerosol output rate = 0.07 ml/minute;
al (2005) [96] Particle size measured using Malvern residual volume = 1.3 ml; inhaled fraction
Mastersizer-X (laser diffraction). = 28 %; time for nebulization = 5 minutes
4 seconds.
Multisonic Independent test Tested nebulizer with NaCl (0.9%) and Measured: volume-mean droplet diameter
Profi report by Steckel Disodium Cromoclycate (20 mg/ml). = 4.4 µm (NaCl), 4.2 µm (Disodium
(2002) [97] HELOS laser diffractometer used to Cromoclycate); output rate = 0.31
determine particle size distribution and g/minute; nebulization time = 5.3 minutes
a multi-stage liquid impinger was used (NaCl), 6.2 minutes (Disodium
to determine total fine particle fraction Cromoclycate).
(<5 µm) and delivered fine particle
fraction.

CEP09018: October 2009


Appendix 1: Summary of evidence 137

Table 22. Summary of in vitro performance testing of Smiths Medical nebulizers


Device Author Method Results
Mini-Neb Hunke et al Tested nebulizer using PulmoAide Measured: average particle size = 3.19 ±
(1987) [44] compressor with Bitolterol Mesylate 1.9 µm and 3.0 ± 1.8 µm; percentage drug
solution 0.2 % diluted with 0.9 % captured by each stage of the cascade
Sodium Chloride solution. Particle size impactor.
distribution was determined using
Anderson cascade impactor.
Mini-Neb Smith et al Tested nebulizer using Inspiron Measured: MMAD = 6.8 µm for 2.5 ml and
(1995) [59] compressor. Used sterile water (2.5 ml 6.9 µm for 5.0 ml; percentage < 5 µm = 35
and 5.0 ml fill volumes) and Malvern % for 2.5 ml and 5.0 ml; compressor noise
Master Sizer MS20 (laser diffraction) to output; compressor energy consumption;
determine droplet size. volume output after 5, 10, 20 minutes.

Table 23. Summary of in vitro performance testing of Unomedical nebulizers


Device Author Method Results
Opti-Mist Plus Independent Tested using 0.9% Saline, at 23 ± 2°C, Measured MMAD; GSD; residual volume
testing by 40-60% RH following Australian/New at normal, 45° and 90° orientations;
Nelson Zealand Standard 4236:1994 and US minimum fill volume at normal, 45° and
Laboratories, FDA requirements, 1993. Measured 90° orientations; non-spill volume.
Inc. [100] particle size using Anderson 8-stage
cascade impactor at two flow rate: 8 &
10 l/minute.
Opti-Mist Plus Independent Compared the Unomedical Opti-Mist Measured MMAD; GSD; residual volume
testing by Plus and Up-Mist with Salter Labs at normal, 45° and 90° orientations;
Nelson 8900, Huson Micro Mist, Intersurgical minimum fill volume at normal, 45° and
Laboratories, Cirrus and Philips Respironics 90° orientations; non-spill volume.
Inc. [42] Sidestream. Tested nebulizers using
0.9% Saline, at 23 ± 2°C, 40-60% RH
following Australian/New Zealand
Standard 4236:1994 and US FDA
requirements, 1993. Measured particle
size using Anderson 8-stage cascade
impactor.
Up-Mist Independent Compared the Unomedical Opti-Mist Measured MMAD; GSD; residual volume
testing by Plus and Up-Mist with Salter Labs at normal, 45° and 90° orientations;
Nelson 8900, Huson Micro Mist, Intersurgical minimum fill volume at normal, 45° and
Laboratories, Cirrus and Philips Respironics 90° orientations; non-spill volume.
Inc. [42] Sidestream. Tested nebulizers using
0.9% Saline, at 23 ± 2°C, 40-60% RH
following Australian/New Zealand
Standard 4236:1994 and US FDA
requirements, 1993. Measured particle
size using Anderson 8-stage cascade
impactor.

CEP09018: October 2009


Appendix 1: Summary of evidence 138

Table 24. Summary of in vitro performance testing of Vital Signs nebulizers


Device Author Method Results
Acorn II Loffert et al Tested nebulizer with Albuterol (0.5 ml Measured: total volume output = 1.61 ml;
(1994) [51] + 2 ml saline) using DeVilBiss time of total output = 20.95 minutes;
Pulmoaide 5610D compressor. PMS percentage of particles in respirable range
CSASP-100 laser diffractometry particle (1-5 μm) = 44.54 %; respirable rate =
size analyser used. 0.0344 ml/minute.
Acorn II Weber et al Tested nebulizer using: saline (0.9 % Measured: MMAD; RF; aerosol output
(1997) [32] w/w Sodium Chloride in distilled water); rate; also given are osmolality, viscosity,
Gentamicin; Tobramycin Sulphate; pH and surface tension for various drug
Ceftazidime Sodium salt; Ciprofloxacin; concentrations.
Colistimethate Sodium. Used two
differenent compressors: Pulmo-Aide
and PARI Master. Used Malvern
Mastersizer (laser) to determine particle
size.
Acorn II Standaert et al Considered the effect on performance Baseline assessment with Saline values
(1998) [37] of disposable nebulizers when were: MMD = 5.33 ± 0.33 µm; GSD = 2.06
repeatedly re-used. Four solutions were ± 0.09; percentage of aerosol in the range
used: 0.9% saline (baseline); 1-3 µm = 15.2 ± 1.8 %; percentage of
Gentamicin Sulfate in saline; aerosol in the range 1-5 µm = 38.4 ± 3.9
Tobramycin; Albuterol Sulphate and %; continuous output = 0.141 ± 0.014
Cromolyn solution. ml/minute; nebulization duration = 28.4 ±
3.3 minutes; residual volume = 1.39 ± 0.15
ml. Data for other solutions was largely
presented in graphical form.
Acorn II Ho & Coates Tested nebulizer with Saline, Measured: MMD = 9.08 µm at low flow,
(1999) [54] Salbutamol and Tobramycin at two 3.70 µm at high flow using Saline; RF
different flow rates: 4 and 10 l/minute. (shown graphically); nebulization time
Used Malvern Mastersizer X (laser ranged between 14.3-18.7 minutes at 6
diffractometry) to determine particle l/minute and 10.8-14.7 minutes at 8
size. l/minute.
Respirgard II O’Doherty et al Tested nebulizer with Pentamidine and Measured: MMD, ranged between 1.9-2.3
(1989) [101] Pentamidine labelled 99mTc human µm; percentage of droplets < 5 μm = 96%.
serum albumin. Particle size measured
using Malvern 2600MSD laser particle
sizer.
Respirgard II Hager et al Tested nebulizer using Pentamidine Measured: MMD = 1.91-2.51 μm; duration
(1992) [103] H2O solution (60 mg/6 ml and 300 mg/6 of nebulization.
ml). Particle size measured using
Malvern Master sizer
Respirgard II Ilowite et al Tested the nebulizer with a solution of Measured: MMAD = 0.90 ± 0.08 μm; GSD
(1991) [102] 60 mg Pentamidine and Technetium = 1.80 ± 0.03;
99m bound to human serum albumin in effective output = 10.50 ± 1.03;
4 ml distilled water. Nebulizer modified
for use while supine with 5” flexible time for nebulization = 28.2 ± 3.3 minutes.
tubing on the inspiratory end. Particle
size measured using eight-stage
cascade impactor. Calibrated 6 l/min
flow rate.
Respirgard II Diot et al (1995) Tested nebulizer using Amphotericin B Measured: MMAD = 0.27 µm and 0.3 µm
[104] suspension with sterile water. Particle for isotopic and assay methods
size measured using 10-stage cascade respectively; GSD = 1.22; inhaled mass =
impactor and Harvard ventilator. 5.8 % and 3.6 % for duplicate runs.

CEP09018: October 2009


Appendix 1: Summary of evidence 139

Table 24. Summary of in vitro performance testing of Vital Signs nebulizers (continued)
Device Author Method Results
Respirgard II Véra et al (1995) Tested nebulizer with Measured: MMAD = 1.94 μm (MP), 2.19
[30] Methylprednisolone (MP) and μm (MP + HSA); GSD = 1.81 (MP), 1.87
Methylprednisolone labelled with (MP + HSA).
99mTc human serum albumin (MP
+HAS). 2ml fill volume.
Respirgard II Tandon et al Tested nebulizer using Albuterol in Measured: percentage weight change =
(1997) [46] saline with 99mTc tracer. Aerosol 59.024 %; percentage aerosol produced =
output rate was determined 31.109 %.
gravimetrically and by measureing
radioactivity.
Whisper Jet Loffert et al Tested nebulizer with Albuterol (0.5 ml Measured: total volume output = 1.04 ml;
(1994) [51] + 2 ml saline) using DeVilBiss time of total output = 8.82 minutes;
Pulmoaide 5610D compressor. PMS percentage of particles in respirable range
CSASP-100 laser diffractometry particle (1-5 μm) = 37.18 %; respirable rate =
size analyser used. 0.0446 ml/minute.
Whisper Jet Waldrep et al Tested nebulizer with Beclomethasone Measured: MMAD = 2.4 ± 0.4 μm; GSD =
(1994) [110] Dipropionate combined with DLPC. 2.8 ± 0.5; amount of Bec-DP recovered in
Measured particle size using Anderson 2.5 minutes from the Anderson sampler.
sampler (independently verified using
model 3300 TSI laser particle sizer).
Whisper Jet Hess et al (1996) Tested nebulizer using Albuterol and Measured (data represented graphically):
[36] saline solution. Measured particle size MMAD; GSD; respirable mass; inhaled
using 11-stage cascade impactor at 3 mass; dead volume; nebulization time.
different flow rates.
Whisper Jet Ho & Coates Tested nebulizer with Saline, Measured: MMD = 8.89 µm at low flow,
(1999) [54] Salbutamol and Tobramycin at two 4.03 µm at high flow using Saline;
different flow rates: 4 and 10 l/minute. RF(shown graphically); nebulization time
Used Malvern Mastersizer X (laser ranged between 12.9-18.0 minutes at 6
diffractometry) to determine particle l/minute and 8.5-12.5 minutes at 8
size. l/minute..
Whisper Jet O’Riordan et al Tested nebulizer with 3 ml Albuterol + Measured: MMAD = 3.2 μm
(1999) [88] 99mTc tracer. Measured particle size (spontaneous), 1.4 μm (ventilation); GSD
using 10-stage cascade impactor for = 2.3 (spontaneous), 2.0 (ventilation).
spontaneous breathing and during
mechanical ventilation.
Whisper Jet Katz et al (2006) Tested nebulizer with three different Measured: Total drug output = 52.25 %
[57] drug solutions: Sildenafil; Tezasentan; (mean); output rate (graphical)
Prostacyclin. Particle size determined
using Malvern Mastersizer X (laser
diffraction).

CEP09018: October 2009


Appendix 1: Summary of evidence 140

Table 25. Summary of in vitro performance testing of Westmed nebulizers


Device Author Method Results
VixOne Hess et al (1996) Tested nebulizer using Albuterol and Measured (data represented graphically):
[36] saline solution. Measured particle size MMAD; GSD; respirable mass; inhaled
using 11-stage cascade impactor at 3 mass; dead volume; nebulization time.
different flow rates.
VixOne O’Riordan et al Tested nebulizer with 3 ml Albuterol + Measured: MMAD = 2.3 μm
(1999) [88] 99mTc tracer. Measured particle size (spontaneous), 1.2 μm (ventilation); GSD
using 10-stage cascade impactor for = 2.2 (spontaneous), 2.0 (ventilation).
spontaneous breathing and during
mechanical ventilation.
VixOne Zhou et al (2005) Tested nebulizer with Albuterol and Measured: Albuterol at 22°C: MMAD =
[40] Budesonide solution at 10 and 22°C. 1.63 µm; GSD = 1.92; RF = 43.06 %.
Measured particle size using Anderson Albuterol at 10°C: MMAD = 4.34 µm; GSD
8-stage cascade impactor. = 2.00; RF = 30.00 %. Budesonide at
22°C: MMAD = 3.04 µm; GSD = 1.88; RF
= 19.19 %. Budesonide at 10°C: MMAD =
5.35 µm; GSD = 1.86; RF = 11.62 %.
VixOne Cardinal Health Compared the Cardinal Health Misty Measured: MMAD = 2.08 µm; GSD =
in-house test Max 10 with the Westmed VixOne, 2.61; RF (< 4.7 µm) = 74.4 %; output rate;
report [24] Hudson Micro Mist and Salter 8900. treatment time = 8.2 minutes; residual
Used Albuterol Sulphate. Particle size volume = 1319 µg; inhaled respirable
measured using Anderson 8-stage mass = 336 µg.
cascade impactor.

CEP09018: October 2009


Appendix 1: Summary of evidence 141

Table 26. Summary of in vivo testing


Device Author Method Results

Philips Reychler et Study population: 10 healthy male subjects The mean dose of aerosol deposited in both
Respironics al (2004) Solution nebulized: 99mTc- lungs was lower in the IPV device compared
SideStream [89] diethylenetriaminepentaacetic acid with the SideStream.
(Compared with Measured parameter: Aerosol distribution in region The penetration index (ratio of pheripheral
a nebulizer of an of interest in lungs to central) was not significantly different
intrapulmonary between the two devices. The amount of
percussive Method: Each subject was nebulized with each aerosol depositied in the central and
ventilation (IPV) device with a 3 day interval between each study. peripheral areas of the right lung was also
device – As soon as nebulization was complete, a 3-head comparable between the two devices.
Percussionaire) gamma camera scan was undertaken with the
patient supine. A 60° angle emission tomography
of the entire thorax was acquired for a duration of
10 min. This was followed by a transmission
tomography.
The regions of interest were the peripheral and
central regions.
PARI LC Newman et Study population: 10 healthy subjects The LC nebulizer when operated
(Compared with al (1994) Solution nebulized: 30 MBq 99mTc labelled intermittently deposited 15.3% of dose in
PARI LL, which [70] diethylenetriaminepentaacetic acid the lungs and 12.8% when operated
is not in market continuously. The ratio of peripheral to
Measured parameter: Tracer distribution central lung deposition was the same for
review) determined from radioactivity count rates both at 1.4. There was a trend for a great
Method: The LC nebulizer was study using a lung deposition for the LC nebulizer,
manual interrupter for intermittent delivery and with particularly when operated intermittently, but
continuous delivery. Each subject performed 3 it was not statistically significant.
inhalation studies at least 24 hrs apart. They
inhaled from the nebulizer for 15 mins and then
posterior and anterior images of the lungs were
taken as well as lateral images of the upper
airways. Images were also taken of the exhalation
filter and nose-plugs after administration and of the
nebulizer before and after administration. All
counts were corrected for background radioactivity
and where appropriate, radioactivity decay.
PARI LC Plus Laube et al Study population: 8 subjects with cystic fibrosis The deposition fraction in both lungs was
(2005) [84] and an FEV1 ≥ 40% 6.10% (mean) with the PEP device
Solution nebulized: Saline containing compared with 10.76% (mean) without PEP
99m
technetium device.
Measured parameter: deposition fraction, The mean inner-outer ratio with PEP was
deposition pattern lower that without PEP (2.01±0.69 vs
2.76±1.33), because there was an average
Method: This study considers the effect on positive increase of aerosol in outer region with a
expiratory pressure (PEP) on the aerosol decrease in the inner region.
distribution in the lungs of patients with CF. On
one study day patients were nebulized whilst The mean apex-base ratio was not
exhaling through a PEP device. On the other study significantly different between with and
day, patients exhaled through a low-resistance without PEP.
filter. Once nebulization was complete, a posterior
gamma-camera lung scan was undertaken. The
regional distribution was quantified in terms of the
radioactivity deposited in the inner, outer, apical
and basal regions of the right lung.
On the 1st study day, prior to nebulization, each
patient underwent 2 scans: A transmission scan
and a 133xenon ventilation scan. The transmission
scan was used to determine lung deposition
fraction and the ventilation scan was used to
define the functional border of the right lung.

CEP09018: October 2009


Appendix 1: Summary of evidence 142

Table 26. Summary of in vivo testing (continued)


Device Author Method Results

PARI LC Plus Coates et al Study population: 5 nonsmoking male subjects For the LC Plus, the total lung deposition
eFlow (2007) [66] Solution nebulized: tobramycin labelled with 99mTc was 15.9±2.8%. The half-life for clearance
of 99mTc-DTPA was a mean of 72 mins.
Measured parameter: Regional lung deposition,
clearance of the radiolabel from lungs For the eFlow, the nebulization time was
2.5±0.4 min, giving a total lung deposition of
Method: Subjects were nebulized with LC Plus for 32.0±3.4%. The half-life for clearance of
10 mins and until the nebulizer well was empty 99m
Tc-DTPA was a mean of 66 mins.
with the eFlow. Post-nebulization, the subjects
rinsed their mouths and throat with water which
was swallowed in order to move all oral pharyngeal
deposition into the stomach. Using a two-headed
gamma camera, the total dose deposited in the
lungs was counted and the clearance of the
radiolabel from their lungs was determined, by
repeating image capture at 5, 10, 15 and 25 mins
after nebulization. Nebulization was done seated,
but imaging was performed supine.
Smiths Medical Lewis & Study population: 6 normal, non-smoking adults The mean percentage deposited in the body
Mini-Neb Fleming and 2 atopic asthmatics was 14%; 12.4% was in the lungs, 1.5% in
(1985) [98] Solution nebulized: 99mtechnetium labelled human the mouth.
serum albumin suspended in saline 86% of the dose was either in the expired
Measured parameter: fractional deposition air or deposited in the mouthpiece, 2-way
valve and tubing of the nebulizer system.
Method: Subjects inhaled the aerosol at 30 breaths
per min for 30 s. Immediately afterwards, images In normals, the lung fraction was 12.9%,
of the anterior and posterior view of the lung field where as in the 2 asthmatic lung deposition
including the stomach, the stomach and intestines, was 3.9% and 18.3%.
and the head and neck were taken using a
Siemens LFOV gamma camera.
To quantify the distribution of radioactivity in the
body, regions of interest were outlined including
the lung the oro- and nasopharynx and the
stomach and gut.
Smiths Medical Clay & Study population: 6 male subjects with mild The mini-neb produced the largest MMD of
Mini-neb Clarke asthma the 3 nebulizers tested. This meant the
(Compared with (1987) [99] Solution nebulized: 99mtechnetium in 0.9% saline pulmonary deposition was significantly
Turret nebulizer lower when using this nebulizer compared
Measured parameter: Proportion of aerosol with the others, with the deposition in the
and Upmist deposited in lungs
nebulizer, oropharynx significantly higher.
neither of which Method: The 3 aerosols were given in a The percentage dose in the lungs from mini-
are in the market randomised, single blinded manner to each subject neb was 44%.
review) with a minimum interval of 3 days between each
study. Baseline lung function measurements were
made on each day. Using krypton gas, a posterior
image of the regional ventilation was obtained to
determine the outlines of the lungs. Once
complete, subject received nebulization for 120 s.
Then an image of the regional deposition in the
lungs was obtained followed by an image of the
oropharyngeal deposition. The imaging procedure
was completed within 7 mins of starting
nebulization.

CEP09018: October 2009


Appendix 1: Summary of evidence 143

Table 26. Summary of in vivo testing (continued)


Device Author Method Results

Vital Signs O’Doherty Study population: 10 patients with AIDS For the Respirgard the addition of
Respirgard II et al (1990) Solution nebulized: Pentamidine isethoinate with corrugated tubing caused small increases in
(Compared with [105] 99m
technetiume labelled human serum albumin the deposition in all lung regions, but none
System 22 were statistically significant.
Measured parameter: lung deposition
Mizer, which is Comparing sitting and supine studies, there
not in market Method: This study considers the effect of posture was no significant difference in the total
review) on the distribution of pentamidine in the lungs. deposition in lungs, whole right lung,
With the gamma-camera positioned posteriorly, peripheral right lung or lower third of the
dynamic images were taken during nebulization, right lung. There was increase in the upper
followed by static images of chest (anterior and third.
posterior), abdomen (anterior and posterior) and The ratio of the upper to lower zones was
oropharynx (right lateral head). This was repeated significantly increased when ‘patient’ was in
in each patient with the sitting and supline. supine position.
A 133Xe scan was recorded for each patient when There was a significant increase in
sitting and supine to all the lung edges, central and nonpulmonary deposition when in supine
peripheral regions and lung thirds to be defined. position.
Vital Signs Simonds et Study population: 9 male patients with AIDS The alveolar deposition of pentamidine was
Respirgard II al (1990) Solution nebulized: Pentamidine isethionate significantly higher using the Respirgard II
(Compared with [106] labelled with 99mTc-Sn-colloid system (73±12%). Deposition of the system
Acorn System was reduced by removing the baffle.
Measured parameter: Aveoloar deposition over 24
22, which is not hrs
in market review)
Method: Respirgard was studied in standard
format and with the 1-way baffle valve between
nebulizer and mouthpiece removed.
Each patient was pretreated with nebulized with
terbutaline. Pentamidine was nebulized to dryness
over a 10 min period. Patients were asked to
complete a visual scale of the effect of aerosol on
breathing and rank nebulizers in order of
preference.
Image of lungs were taken immediately after
nebulization and after 24 hrs. Both counts were
corrected for background radioactivity and the 24
hr figure was adjusted for 99mTc decay.
Vital Signs Ilowite et al Study population: 10 homosexual male subjects The average percentage lung dose for the
Respirgard II (1991) [102] with AIDS or HIV+ Respirgard was 5.33%, which was
(Compared with Solution nebulized: Pentamidine mixed with 99mTc- significantly lower than the other nebulizers.
Aero Tech II, HSA The percentage extrapulmonary deposition
Portasonic and was 0.40%, which was significantly less
Measured parameter: Regional deposition than the other nebulizers.
Fisoneb, none of
which are in the Method: Each subject was studied weekly, blinded
market review) to the type of nebulizer used. Nebulization was run
to ‘dryness’. Subject were asked to rate the side
effects including, metallic taste, cough and
bronchospasm.
At the beginning of study a xenon scan was
obtained as a baseline for characterizing regional
deposition.
Dosage to the lung and extrapulmonary regions
were determined by measuring nCi in the lungs
and stomach.

CEP09018: October 2009


Appendix 1: Summary of evidence 144

Table 26. Summary of in vivo testing (continued)


Device Author Method Results

Vital Signs Smaldone Study population: 22 HIV+ patients (11 impatients, Differences in the deposition fraction were
Respirgard II et al (1991) 11 outpatients) not significant between the two nebulizers.
(Compared with [107] Solution nebulized: Pentamidine labelled with The differences in the central/peripheral
99m
AeroTech II, technetium human serum albumin ratio of the two nebulizers were also not
which is not in Measured parameter: Deposition significant.
market review)
Method: Deposition was measured in two ways in
the study: 1) Comparison of radioactivity on
inhaled and exhaled filters; 2) Gamma camera
scans immediately after nebulization and after 24
hrs.
Each patient had a Xenon scan prior to
assessment, to outline lungs, defining central and
peripheral regions.
Vital Signs Hardy et al Study population: 10 healthy subjects 89% (median) of the dose was retained
Respirgard II (1993) [108] Solution nebulized: sodium chloride containing 60 within the RespirGard II, with only 9% being
(Compared with MBq99Tmm-labelled diethylenetriaminepentaacetic deposited in lungs. This was a significantly
PARI Boy 37.80, acid poor performance than seen in the PARI
PARI IS-2 and nebulizers; however the mean ratio of the
Measured parameter: Tracer distribution peripheral to central deposition was
Penta-Sonic, determined from radioactivity count rates
none of which significantly great in the RespirGard at 2.1,
are in the market Method: Each subject was dosed on 4 separate compared with 1.6 and 1.3.
review) days with a different nebulizer each day.
Immediately after dosing posterior and anterior
images of the lungs and stomach and a lateral
image of the oropharynx were recorded using a
gamma camera. The count rates were determined
for the central, intermediate and peripheral regions
of the lungs, the stomach, oesophagus and
oropharynx, correcting each for background
counts. The radioactivity in each nebulizer system
imaged before and after dosing.
Vital Signs O’Riordan Study population: 10 male HIV+ subjects The regional deposition normalised for
Respirgard II & Solution nebulized: pentamidine labelled with 5mCi regional ventilation for upper and lower
(Compared with Smaldone technetium bound to human serum albumin regions was 0.87 (mean) with albuterol and
Fisoneb, which (1994) [109] 0.78 (mean) without for the Respirgard. For
Measured parameter: Regional deposition and the central to peripheral regions with
is not in market regional ventilation
review) albuterol the ratio was 1.06 and without
Method: Each subject was studied with both 1.03. All these measurements were lower
nebulizers on each day of the 2 day trial. On the 1st than those for the Fisoneb.
day each subject was given a dose of albuterol
before nebulization. Posterior images were made
during nebulization using krypton gas and images
showing technetium were taken once nebulization
was finished. The krypton images were used to
divide the lung into central and peripheral regions
and upper and lower regions. The technetium
deposition pattern was normalised for ventilation.

CEP09018: October 2009


Appendix 1: Summary of evidence 145

Table 26. Summary of in vivo testing (continued)


Device Author Method Results

Vital signs Diot et al Study population: 3 patients with post-tuberculosis For deposition to the whole lung, the
Respirgard II (1995) [104] lung aspergilloma Respirgard nebulizer performed poorly
(Compared with Solution nebulized: Amphotericin B labelled with compared to the other two nebulizers, both
Fisoneb and 99m
Tc of which were ultrasonic devices. This was
DP100, neither the same in all regions of the lung.
Measured parameter: Regional deposition
of which are in
market review) Method: Each patient received a daily dose of
amphotericin B for 4 weeks. On the 5th day of each
of the first 3 treatment weeks, patients inhaled
99m
Tc amphotericin B and as soon as nebulization
was complete an anterior view of the chest was
taken. The nebulizer charge was counted before
nebulization began. Regions of interest were
drawn on the each image including the central and
peripheral zones, the upper and lower halves and
upper halve of a single lung where aspergilloma
was located.
Vital Signs Véra et al Study population: 5 healthy subjects For the Respirgard the peripheral-to-central
Respirgard II (1995) [30] Solution nebulized: Methylprednisolone labelled activity ratio was 2.8±0.3 counts per
DeVilbiss with 99mtechnetium human serum albumin second, compared with 2.2 ±0.3 counts per
Ultraneb 99 second for Ultraneb.
Measured parameter: Pulmonary and
extrapulmonary deposition The peripheral activity was 830±288 counts
per second for the Respirgard compared
Method: Each subject underwent dynamic imaging with 1487±174 counts per second for
acquiring the posterior view for 16 mins. Ultraneb.
Nebulization began after 1 min. At the end of
nebulization 2 static images were taken; one of the The central activity was 301±115 counts per
stomach (anterior view) and the other of the second for Respirgard compared with
orophyarynx (left lateral view). 668±131 counts per second for Ultraneb.
Each subject also had a xenon scan to define the
lung outline and determine the central and
peripheral regions.

CEP09018: October 2009


Appendix 2: Supplier contact details 146

Aerogen Ltd.
Tel: 01865 292 018
1st Floor Belsyre Court
57 Woodstock Road Fax: 01865 292 073
Oxford website: www.aerogen.com
OX2 6HJ
email: info@aerogen.com
Inspiration Healthcare Limited Tel: 01455 840 555
Gildor House
West Street Fax: 01455 841 464
Earl Shilton website: www.inspiration-healthcare.co.uk
Leicester
LE9 7EJ email: info@inspiration-healthcare.co.uk

Afp Medical
Tel: 01788 579408
71 Somers Road
Rugby Fax: 0845 8621799
Warwickshire website: afpmedical.01788.co.uk
CV22 7DG
email: info@afpmedical.com

Cardinal Health UK Ltd.


Tel: 08706 011011
The Crescent
Jays Close Fax: not known
Basingstoke website: www.cardinal.com/uk
RG22 4BS
email: mps_ukinfo@cardinal.com

Clement Clarke International Limited


Tel: 01279 414 969
Edinburgh Way
Harlow Fax: 01279 456 304
Essex website: www.clement-clarke.com
CM20 2TT
email: resp@clement-clarke.com

DeVilbiss Healthcare
Sunrise Medical Ltd. Tel: 01384 446 688
Sunrise Business Park
High Street Fax: 01384 446 699
Wollaston website: www.devilbisshealthcare.com
Stourbridge
DY8 4PS email: CS@DeVilbissHC.com

CEP09018: October 2009


Appendix 2: Supplier contact details 147

Flaem Nuova
Albert Waeschle Tel: 01202 601 177
11 Balena Close
Creekmoor Fax: 01202 650 022
Poole website: www.aw-online.com
Dorset
BH17 7DX email: enquiries@albertwaeschle.co.uk
Cardiacare Ltd. Tel: 01277 812 968
Unit 7 Cockridden Farm
Brentwood Road Fax: 01277 812 660
Herongate website: www.cardiacare.co.uk
Brentwood
CM13 3PN email: info@cardiacare.co.uk
Deva Medical Electronics Ltd. Tel: 01928 567 571
1 Chandlers Court
Picow Farm Road Fax: 01928 580 788
Runcorn website: www.deva-medical.com
Cheshire
WA7 4UH email: jwright@deva-medical.com

Flexicare Medical Ltd.


Tel: 01443 471 580
Cynon Valley Business Park
Mountain Ash Fax: 01443 474 222
Mid Glamorgan website: www.flexicare.com
CF45 4ER
email: enquiries@flexicare.com

Hudson RCI
Teleflex Medical Tel: 01494 532 761
Cressex Business Park
Stirling Road Fax: 01494 524 650
High Wycombe website: www.hudsonrci.com
Bucks
HP12 3ST email: info.uk@teleflexmedical.com

Intersurgical Ltd.
Crane House Tel: 01189 656 300
Molly Millars Lane Fax: 01189 656 356
Wokingham
Middlesex website: www.intersurgical.com
RG41 2RZ email: info@intersurgical.com

CEP09018: October 2009


Appendix 2: Supplier contact details 148

Meditech Systems Ltd.


Unit 3 Richmar Tel: 01258 471 770
Butt's Pond Industrial Estate Fax: 01258 471 772
Sturminster Newton
Dorset website: www.electrosurgery.co.uk
DT10 1AZ email: sales@electrosurgery.co.uk

MGE Medical
GBUK Healthcare Tel: 01757 288 587
Blackwood Hall Business Park Fax: 0845 280 3160
North Duffield
Selby website: www.gbukhealthcare.co.uk
YO8 5DD email: info@gbukhealthcare.com

Norditalia Elettromedicali SRL


Merlin Medical Ltd. Tel: 01685 843 676
The Maerdy Industrial Estate Fax: 01685 843 860
Rhymney
Gwent website: www.merlin-medical.com
NP22 5PY email: sales@merlin-medical.co.uk
Williams Medical Supplies Ltd. Tel: 01685 844 739
The Maerdy Industrial Estate Fax: 01685 844 725
Rhymney
Gwent website: www.wms.co.uk
NP22 5PY email: sales@wms.co.uk

Omron Healthcare Ltd.


White Medical Tel: 01788 553 904
Meranti Lodge
Hillmorton Lane Fax: 01788 560 820
Clifton upon Dunsmore website: www.white-medical.co.uk
Rugby
CV23 0BA email: enquiries@white-medical.co.uk
Medisave (UK) Ltd. Tel: 0800 804 6447
Unit 1
Littlesea Ind Est Fax: 0800 804 6448
Weymouth website: www.medisave.co.uk
Dorse
DT4 9DN email: helpdeskuk@medisave.net

CEP09018: October 2009


Appendix 2: Supplier contact details 149

PARI Medical Ltd.


The Old Sorting Office Tel: 01932 341 122
Rosemount Avenue Fax: 01932 341 134
West Byfleet
Surrey website: www.pari.de
KT14 6LB email: infouk@pari.eu

Philips Respironics
Philips Respironics (UK) Ltd. Tel: 0800 130 0845
Chichester Business Park
Fax: 0800 130 0846
City Fields Way
Tangmere website: www.respironics.co.uk
Chichester
email: rukcustomerservices@respironics.com
PO20 2FT
Livingaids Ltd. Tel: 02392 525 325
Unit 6 Nimrod Drive
14 Hillary Court Fax: 02392 529 766
Rowner website: www.livingaidsonline.co.uk
Gosport
PO13 8BE email: sales@livingaidsonline.co.uk

Mashco Limited Tel: 0208 204 2224


Synergy Complex Fax: 0208 204 0224
4 Dalston Gardens
Stanmore website: www.mashco.co.uk
HA7 1BU email: sales@mashco.co.uk

Salter Labs
Ritchie Surgical Ltd. Tel: 01757 288 808
11a Blackwood Hall Business Park Fax: 01757 288 808
North Duffield
Selby website: www.salterlabs.com
YO8 5DD email: teddunstan@ritchie-surgical.co.uk

Schill Medical
Aston Clinton Scientific Limited Tel: 01923 676 499
2 Garnett Drive Fax: 01923 676 499
Bricket Wood
St Albans website: www.schillmedical.com
AL2 3QN email: AdamBunting@schillmedical.com

CEP09018: October 2009


Appendix 2: Supplier contact details 150

Smiths Medical UK
Tel: 01923 246434
Colonial Way
Watford Fax: not known
Herts website: www.smiths-medical.com
WD24 4LG
email: ukcs@smiths-medical.com
Henleys Medical Supplies Ltd. Tel: 01707 333 164
Brownfields
Welwyn Garden City Fax: 01707 334 795
Hertfordshire website: www.henleysmed.com
United Kingdom
AL7 1AN email: enquiries@henleysmed.com

Unomedical Ltd.
27 Thornhill Road Tel: 1527 587 700
North Moons Moat Fax: 1527 592 111
Redditch
Worcestershire website: www.unomedical.com
B98 9NL email: redditch.customers@unomedical.com

Vital Signs Ltd.


13-14 Eldon Way Tel: 08456 444 955
Lineside Industrial Estate Fax: 08456 444 966
Littlehampton
West Sussex website: www.vital-signs.co.uk
BN17 7HE email: vitalcare@vital-signs.co.uk

Westmed
Intermedical (UK) Ltd. Tel: 01732 522 444
Unit 6 Mill Hall Business Estate Fax: 01732 872 883
Aylesford,
Kent website: www.intermedical.co.uk
ME20 7JZ email: info@intermedical.co.uk

CEP09018: October 2009


Appendix 3: EU procurement procedure 151

Lease options
National frameworks are in place for operating leases to help the NHS procure
leases more cost efficiently and effectively. The framework came into place on 1st
April 2007 and runs for two years. Further details are available from the PASA
website [112].

EU procedures
The Public Sector Directive (2004/18/EC) has been transposed into UK law via the
following statutory instruments:

• the Public Contracts Regulations SI 2006 No.5 (the regulations)


• the Utilities Contracts Regulations SI 2006 No. 6 (not relevant to this guide).

The regulations apply to contracts worth more than £90,319 (from January 1st 2008)
[12] over their whole life, and specify the procedures to be followed for public sector
contracting, including adherence to strict timetables, requirements for advertising,
invitation to tender and the award of contract. Organisations undertaking a
procurement exercise covered by the regulations must give all suppliers an equal
opportunity to express an interest in tendering for the contract by placing a contract
notice in the Official Journal of the European Union (OJEU).

At all stages of the procurement process, the purchaser must be demonstrably fair,
as any decision made can be challenged by the unsuccessful suppliers.

Establishing a procurement strategy


To achieve a successful outcome, decisions need to be made on:

• whether an existing contract/agreement can be used


• the need to consider sustainable development issues
• whether EU directives apply
• the type and form of contract
• sourcing potential suppliers
• duration of contract and opportunity to review/extend
• payment schedules
• how to minimise any risks with the chosen strategy, including supplier appraisal
and evaluation/clarification of suppliers’ bids.

CEP09018: October 2009


Appendix 3: EU procurement procedure 152

Preparing a business case


A business case should be drafted and approved before conducting any procurement
exercise. Further guidance on preparing business cases is available from the Office
of Government Commerce [113] and an illustrative example is provided in the NHS
PASA Operational Purchasing Procedures Manual, Procedure 1-01 [114].

The EU tendering exercise


EU procurements usually take between 4 and 6 months to complete. This needs to
be taken into account in the planning stages. The length of the exercise depends on
the chosen procedure (open or restricted). Further information is available from the
Department of Health [115].

The procurement panel


A multidisciplinary team should be selected to guide the purchase. Representatives
from clinical, user, technical, estates and financial areas should be considered.

Identifying potential suppliers


Criteria for supplier selection must be established. A pre-qualification questionnaire,
seeking background information (eg on the skills and experience of the service
engineers) may be employed as an initial screen to exclude unsuitable suppliers.

Evaluation criteria
Performance specifications should be derived from local operational requirements,
and agreed by the procurement panel. They will form the basis for assessing the
adequacy of suppliers’ technical specifications, provided in response to the technical
specification questionnaire.

It is important to have agreed on the performance specifications of the product as


they will be used in the adjudication against company specifications.

Requests for features which are supplier-specific are not permitted under the
regulations. Very specific features which are not supported by operational
requirements are also not allowed.

CEP09018: October 2009


Appendix 3: EU procurement procedure 153

Award of contract
Following award of the contract to the successful supplier; unsuccessful suppliers
may need to be debriefed. This is at the supplier’s request.

Buyers must be aware of the ‘Alcatel’ procedure (see the Trust Operational
Purchasing Procedures Manual [11], Procedure No.T-08, section 6 - Mandatory
Standstill Period).

For more information on procurement please refer to the Department of Health


Website [116].

CEP09018: October 2009


Author and report information 154

Buyers’ guide: Sign up to our email alert


Nebulizers service

C A Reay All our publications since 2002 are


D R Bousfield available in full colour to download
E S Colechin from our website. To sign up to our
J A Menes email alert service and receive new
A J Sims publications straight to your mailbox
contact:
Regional Medical Physics Department
Freeman Hospital Centre for Evidence-based Purchasing
High Heaton Room 152C
Newcastle upon Tyne Skipton House
NE7 7DN 80 London Road
SE1 6HL
Tel: 0191 2137787
Email: rmpdfhevaluation@nuth.nhs.uk Tel: 020 7972 6080
Web: www.rmpd.org.uk Fax: 020 7975 5795
Email: cep@pasa.nhs.uk
About CEP Web: www.pasa.nhs.uk/cep

The Centre for Evidence-based © Crown Copyright 2009


Purchasing (CEP) is part of the Policy
and Innovation Directorate of the NHS
Purchasing and Supply Agency. We
underpin purchasing decisions by
providing objective evidence to support
the uptake of useful, safe and
innovative products and related
procedures in health and social care.

We are here to help you make


informed purchasing decisions by
gathering evidence globally to support
the use of innovative technologies,
assess value and cost effectiveness of
products, and develop nationally
agreed protocols.

CEP09018: October 2009