WEB - CBET - Safety in The Health Care Facility (V14) 1 Slide-Page

Safety in the
Health Care Facility

CBET Certification Review
Myron D. Hartman MS, SASHE, CCE, CRES, CBET
Myron.hartman@biomed-ed.com
www.biomed-ed.com
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CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM
Topics of Discussion
E. Fire
A. Electrical
1. Microshock/Electrical Safety Testing
2. Other
B. Chemical
1. Material Safety Data Sheet
2. Other
C. Radiological
1. Light Spectrum
2. Types of Rays
D. Biological
1. Standard Precautions
2. Other
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1. Class
2. Fire Extinguishers
F. Codes and Standards

1. JCAHO Comprehensive
Accreditation Manual
2. AABB
3. NFPA 99
a. Gas and Vacuum
Systems
b. Electrical Systems
4. FDA
5. SMDA
6. OSHA
7. Other
Electrical Safety
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Classes of Medical Devices

Class G - General Areas
Class H - Critical Care Areas
Class W - Wet Locations
Leakage current Where does it come from?
Impedance (Z) consists of three components
XL Inductance Reactance
XC Capacitance Reactance
R Resistance
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Electrical Safety
Leakage current - Micro & Macro Shock
Micro Shock or Cardiac Shock - is defined as a low value current
(ua), which passes directly through the heart via a needle or
catheter in an artery or a vein
Less than 1ma of current.
Current can still have effect on patients with invasive
equipment, such as: pacemakers, swan-ganz catheters, invasive
blood pressure lines, cardiac cath lines, etc.
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Electrical Safety
Leakage current - Micro & Macro Shock
Macro Shock is defined as a high-value current (ma), which passes
arm to arm through the body by (skin) contact with a voltage
source. There must be two points of body contact. The resulting
current eventually passes through the heart and may cause
ventricular fibrillation of death.
Body can sense shock.

1ma - Threshold of Perception
10-20ma - Let go Current
50ma Pain
100-300ma - Ventricular Fibrillation
6A - Total Myocardial Contraction
>6A - Burns and Respiratory Paralysis
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Electrical Safety
Leakage current
High frequency currents The primary concern of electrical shock is
with 60 hz currents. Medical equipment today may produce leakage
current at higher frequencies, due to harmonics, carrier frequencies
and switching mode power supplies.
Frequencies above 100 khz have current limits increased 100 times that
of low frequency currents
Frequencies from 1 khz to 100 khz have their limits increased on a linear
scale up to 100 times that of the low frequencies.
As the frequency is increased, there is less effect of shock and increased
effect of RF burns
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Electrical Safety
Leakage current
AAMI filter Due to multiple frequencies that could exist in leakage
current the AAMI filter is used to pass only the low frequencies of
interest. High frequencies are shunted to ground, This filter
provides a weighted risk current.
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Electrical Safety
Leakage current
Standards
AAMI Association for the
Advancement of Medical
Instrumentation (2008 Edition)
NFPA 99 National Fire

Protection Agency Health Care
Facilities (2012 Edition)
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Electrical Safety
Current limits Below are the NFPA 99 (2012) recommended
leakage current limits.
Portable Equipment, Touch Current

Chassis, 100 ua with the ground wire intact
Chassis, 500 ua with the ground wire disconnected
Portable Equipment, Lead Leakage Current, All leads

connected together, power normal and on
100 ua with ground wire
500 ua with open ground wire
Fixed Equipment, Leakage Current

10 ma on ground conductor
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Electrical Safety
Leakage current
Current limits - are measued in the following
configurations:
Device ground
Device power
Device polarity (hot/nueutral)
OPEN
ON
NORMAL
CLOSED
OFF
Record the highest measured leakage current and the configuration

(ON/Off, Ground OPEN/CLOSED and Polarity NOR/REV)
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Electrical Safety
Grounding
Why it is necessary Provides the least amount of resistance for
leakage current to flow back to the power source.
Current will always take the least path of resistance.
Leakage current exists in all electrically powered devices, therefore a
ground is required to remove the current.
Ground conductor is also required for faults or failures with the device
so currents have a safe path to follow.
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Electrical Safety
Grounding
Where it is measured from the device chassis to the ground pin of the
power plug.
If possible, the plug should be removed from the receptacle with the
power off.
If the device is hard wired, the ground can still be measured from the
metal chassis to a ground on the electrical distribution system
(power off).
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Electrical Safety
Grounding
Measurement limits the maximum grounding resistance should not be
greater that 0.5 ohms.
While measuring, the power cord should be twisted and moved at the
strain relief to the device and at the power plug to check for loose
connections.
Redundant grounds should be removed if the device can not be
unplugged.
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Power Plugs & Outlets
Hospital Grade - Green Dot

Cut Wires for hot/neutral shorter
Ground Pin Longer - first to make, last to break
Wire Colors:
Ground Green (US) or Green-Yellow Stripe (Europe)
Hot Black (US) or Brown (Europe)
Neutral White (US) or Blue (Europe)
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Normal Power Outlets - Ivory/Brown

Normal/Emergency Outlets - Red
Isolated Ground Outlets - Orange
Surge Protected Blue
Tamper Proof - Pediatric & Psychiatric
Ground Fault Circuit Interrupters (GFCIs) Class W
Cover Plates & Circuit Identification
Hospital Grade Rating
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Ground Fault Circuit Interrupter (GFCI)
Wet Locations, Shock Hazard Elimination, No Life
Support Equipment, Trip Point 5 ma.
Line Isolation Monitors (LIMS)
Shock Hazard Elimination, Trip Point 5-20 ma,
Isolation Transformer
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120 Volt Receptacle Testing

Voltage & Frequency
Measured from Neutral to Hot on receptacle
120 V RMS is the expected, +/- 5% (114 126 V)
60 Hz is the expected, +/- 0.5% (59.7 60.3 Hz)
Wiring Polarity
The Hot connection is connected to the hot on the electrical
distribution system
The Neutral connection is connected to the neutral on the
electrical distribution system, which is connected to the
ground
Pin Tension
At least 4 ounces of pull on each blade
Ground to Ground resistance

Must be less than 0.1 ohms
Ground to Neutral resistance

Must be less than 0.1 ohms
Faceplate cracked/broken
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Emergency Generator Testing

Power must be supplied within 10 seconds from time of utility
interruption
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Radiological Light
Spectrum
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Classifications of EM radiation is by wavelength

Radio wave - Radio waves generally are utilized by antennas of appropriate size,
with wavelengths ranging from hundreds of meters to about one millimeter.
They are used for transmission of data, via modulation. Television, mobile
phones, wireless networking and amateur radio all use radio waves
Microwave - Microwaves are waves which are typically short enough to employ
tubular metal waveguides of reasonable diameter. Microwave energy is
produced with klystron and magnetron tubes, and with solid state diodes
such as Gunn and IMPATT devices. Microwaves are absorbed by molecules
that have a dipole moment in liquids. In a microwave oven, this effect is used
to heat food. Low-intensity microwave radiation is used in Wi-Fi, although
this is at intensity levels unable to cause thermal heating.
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Infrared - The infrared part of the electromagnetic spectrum covers the range
from roughly 300 GHz (1 mm) to 400 THz (750 nm). It can be divided into
three parts:
Far-infrared, from 300 GHz (1 mm) to 30 THz (10 m). The lower part of this
range may also be called microwaves. This radiation is typically absorbed by socalled rotational modes in gas-phase molecules, by molecular motions in liquids,
and by phonons in solids.
Mid-infrared, from 30 to 120 THz (10 to 2.5 m). Hot objects (black-body
radiators) can radiate strongly in this range. It is absorbed by molecular
vibrations, where the different atoms in a molecule vibrate around their
equilibrium positions. This range is sometimes called the fingerprint region since
the mid-infrared absorption spectrum of a compound is very specific for that
compound.
Near-infrared, from 120 to 400 THz (2,500 to 750 nm). Physical processes that are
relevant for this range are similar to those for visible light.
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Visible (region we perceive as light) - This is the range in which the sun and
stars similar to it emit most of their radiation. It is probably not a coincidence
that the human eye is sensitive to the wavelengths that the sun emits most
strongly. Visible light (and near-infrared light) is typically absorbed and
emitted by electrons in molecules and atoms that move from one energy
level to another. The light we see with our eyes is really a very small portion
of the electromagnetic spectrum. A rainbow shows the optical (visible) part
of the electromagnetic spectrum; infrared (if you could see it) would be
located just beyond the red side of the rainbow with ultraviolet appearing
just beyond the violet end.
EM radiation with a wavelength between 380 nm and 760 nm (790400
terahertz) is detected by the human eye and perceived as visible light. Other
wavelengths, especially near infrared (longer than 760 nm) and ultraviolet
(shorter than 380 nm) are also sometimes referred to as light, especially
when the visibility to humans is not relevant.
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Ultraviolet - This is radiation whose wavelength is shorter than the violet end
of the visible spectrum, and longer than that of an x-ray. Being very energetic,
UV can break chemical bonds, making molecules unusually reactive or
ionizing them, in general changing their mutual behavior. Sunburn, for
example, is caused by the disruptive effects of UV radiation on skin cells,
which is the main cause of skin cancer, if the radiation irreparably damages
the complex DNA molecules in the cells. The Sun emits a large amount of UV
radiation, which could quickly turn Earth into a barren desert. However, most
of it is absorbed by the atmosphere's ozone layer before reaching the
surface.
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X-rays - After UV come X-rays, which are also ionizing, but due to their higher
energies they can also interact with matter by means of the Compton effect.
Hard X-rays have shorter wavelengths than soft X-rays. As they can pass
through most substances, X-rays can be used to 'see through' objects, most
notably diagnostic x-ray images in medicine (a process known as
radiography), as well as for high-energy physics and astronomy.
Gamma rays - After hard X-rays come gamma rays, which were discovered by
Paul Villard in 1900. These are the most energetic photons, having no defined
lower limit to their wavelength. They are useful to astronomers in the study
of high energy objects or regions, and find a use with physicists thanks to
their penetrative ability and their production from radioisotopes. Gamma
rays are also used for the irradiation of food and seed for sterilization, and in
medicine they are used in radiation cancer therapy and some kinds of
diagnostic imaging such as PET scans. The wavelength of gamma rays can be
measured with high accuracy by means of Compton scattering.
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Laser Safety
CLASS 1 - is safe under all conditions of normal use. This means the maximum permissible
exposure (MPE) cannot be exceeded. This class includes high-power lasers within an enclosure
that prevents exposure to the radiation and that cannot be opened without shutting down the
laser.
Class 1M - is safe for all conditions of use except when passed through magnifying optics such
as microscopes and telescopes. Class 1M lasers produce large-diameter beams, or beams that
are divergent
Class 2 - is safe because the blink reflex will limit the exposure to no more than 0.25 seconds. It
only applies to visible-light lasers (400700 nm). Class-2 lasers are limited to 1 mW continuous
wave, or more if the emission time is less than 0.25 seconds or if the light is not spatially
coherent. Intentional suppression of the blink reflex could lead to eye injury. Many laser
pointers are class 2.
Class 2M - is safe because of the blink reflex if not viewed through optical instruments. As with
class 1M, this applies to laser beams with a large diameter or large divergence, for which the
amount of light passing through the pupil cannot exceed the limits for class 2.
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Laser Safety
Class 3R - is considered safe if handled carefully, with restricted beam viewing. With a class 3R
laser, the MPE can be exceeded, but with a low risk of injury. Visible continuous lasers in Class
3R are limited to 5 mW. For other wavelengths and for pulsed lasers, other limits apply.
Class 3B - is hazardous if the eye is exposed directly, but diffuse reflections such as from paper
or other matte surfaces are not harmful. Continuous lasers in the wavelength range from
315 nm to far infrared are limited to 0.5 W. For pulsed lasers between 400 and 700 nm, the
limit is 30 mJ. Other limits apply to other wavelengths and to ultrashort pulsed lasers.
Protective eyewear is typically required where direct viewing of a class 3B laser beam may
occur. Class-3B lasers must be equipped with a key switch and a safety interlock.
Class 4 - include all lasers with beam power greater than class 3B. By definition, a class-4 laser
can burn the skin, in addition to potentially devastating and permanent eye damage as a result
of direct or diffuse beam viewing. These lasers may ignite combustible materials, and thus may
represent a fire risk. Class 4 lasers must be equipped with a key switch and a safety interlock.
Most entertainment, industrial, scientific, military, and medical lasers are in this category.
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Laser Safety
In the U.S., guidance for the use of protective eyewear, and other elements of
safe laser use, is given in the ANSI Z136 series of standards. A full copy of
these standards can be obtained via ANSI or the secretariat and publisher
of these standards, the Laser Institute of America. The standards are as
follows:
ANSI Z136.1 - Safe Use of Lasers
ANSI Z136.3 Safe Use of Lasers in Health Care Facilities
The U.S. Food and Drug Administration (FDA) requires all class IIIb and class IV
lasers offered in commerce in the US to have five standard safety features:
1.
2.
3.
4.
5.
a key switch,
a safety interlock dongle,
a power indicator,
an aperture shutter, and
an emission delay (normally two to three seconds).
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Laser Safety
Maximum permissible exposure (MPE) - is the highest power or energy
density (in W/cm2 or J/cm2) of a light source that is considered safe, i.e.
that has a negligible probability for creating a damage. It is usually about
10% of the dose that has a 50% chance of creating damage under worstcase conditions. The MPE is measured at the cornea of the human eye or at
the skin, for a given wavelength and exposure time.
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Absorption Coefficient A factor in determining the ability of light to be absorbed.

Different types of tissue have varying properties of absorption.
Coherence The ability of waves to maintain a fixed phase in time and space by
adding orderliness to the wave pattern.
Collimation The ability of a laser beam not to spread with distance.
Combiner Mirror A mirror for the joining of 2 or more laser wavelengths beams into
a single coaxial beam.
Contact Probe A probe constructed of synthetic ceramics materials used with laser
fibers, allowing probe contact to tissue directly. This creates a greater degree of
control for low powers to vaporize, coagulate and cut tissue.
Continuous Wave (CW) The steady state delivery of laser power, ANSI regards
beams > 0.25 sec as CW.
Diffraction The ability to deviate part of the beam, specific to the radiation
wavelength as it passes the edge of an opaque barrier.
Divergence or beam spread is the increase in diameter of a laser beam with distance
from the exit aperture.
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Eximer a method of using a gas mixture as the basis of emitting ultraviolet

light with lasers.
Fail Safe Interlock A system that allows for a laser to be placed in a safe
mode, should the interlock system be violated.
Fiberoptic the use of glass fibers or flexible quartz as a medium by which
light is transmitted for communication data, images and therapeutic laser
beams.
Focal Length A distance measurement from the secondary nodal point of
a lens to the primary focal point.
Focal Point A point which radiation converges or diverges. In laser
applications is the point where the smallest spot diameter occurs.
Gaussian Curve A normal statistical curve used to show power
distribution in a beam. The curve is used for identifying the geometry of a
laser beam which then controls the laser effects.
Infrared Radiation Electromagnetic radiation that resides within the range
of 0.7 1 mm.
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Laser Safety Officer is an authorized individual who has the responsibility

to evaluate, monitor and ensure that proper control of laser hazards are
being maintained.
Maximum Permissible Exposure (MPE) is a level of laser radiation
exposure less than what would cause harmful effects to the skin or eyes or
to other biological changes. Reference ANSI Z-136.1 Safe Use of Lasers
Mode used to describe how the power of a laser beam is distributed
within the geometry of a laser beam (pulsed or continuous)
Normal Hazard Zone (NHZ) an area that during normal laser operation
exceeds maximum permissible exposure (MPE) level. The hazard may be
caused by reflected or scatted radiation.
Normal Ocular Hazard Distance (NOHD) is the distance along an axis of
the unobstructed beam from the laser to the human eye beyond which the
irradiance or radiant exposure during normal operation is expected to
exceed the appropriate MPE.
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Optical Cavity is required to provide the amplification desired in the laser

and to select the photons traveling in the desired direction.
Optical Coupler is a mirror that partially transmissive, allowing the laser
output from the optical cavity.
Power Density is expressed in watts per square centimeter.
Pulsed Laser is a laser operating mode that delivers energy in the form of
single pulses or an on going chain of pulses that are less than 0.25 seconds.
Single Pulsed (normal mode) is a pulse duration of a few hundred u sec to
a few m sec.
Ultraviolet Light is electromagnetic radiation with a wavelength between
0.2 0.4 um.
Visible Radiation (Light) is electromagnetic radiation with a wavelength
between 0.4 0.7 um and the human eye can detect.
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Type
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Application
Wavelength
Argon
Ophthalmology, photocoagulation
(superficial), and dermatology
488514 nm, CW
Nd: YAG
Photo coagulation
1.06 um (several operating modes)
CO2
Gynecology, bronchoscope
10.6 um, CW
Eximers
Ophthalmology, photoablation
(dermatology), and plastic
surgery Ultraviolet:
Argon fluoride
193 nm
Krypton fluoride
248 nm
Xenon chloride
308 nm
Xenon chloride
351 nm
Dye-tunable
Dermatology, photodynamic therapy,

plastic surgery
400900 nm, CW
Gold Vapor
Photodynamic therapy
628 nm, pulsed
HeNe
HCLS, aiming and photoradiation
633 nm, CW
Laser Diode
(GaAs)
Photoradiation
840 nm, pulsed
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CO2 Lasers
CO2 surgical lasers are used primarily to create surgical incisions,
to excise or vaporize deeper tissues (e.g., to remove tumors)
after incisions, to coagulate very small bleeding vessels, to
vaporize surface anomalies (e.g., warts), and to excise or
vaporize tissue accessible by both rigid and flexible
endoscopes.
CO2 lasers are free-beam lasers; that is, the lasers tip remains
several millimeters away from the tissue during operation.
Use of CO2 surgical lasers offers several advantages over
conventional surgery, including reduced mechanical trauma to
and increased preservation of surrounding tissue and more
easily maintained sterility.
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Nd:YANd:YAG Lasers
Nd:YAG surgical lasers are in general use, particularly in

gastroenterology, urology, gynecology, and general surgical
applications, to photocoagulate, cut, or vaporize tissue.
Nd:YAG surgical laser energy (1,064 nm wavelength) can be
delivered through flexible silica fibers and can pass through
clear fluids, unpigmented tissue, and the top layer of the skin,
making Nd:YAG lasers more effective than other types of lasers
in treating certain medical conditions.
There are two types of Nd:YAG lasers
general surgical
ophthalmic
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Ho:YAG Lasers
Ho:YAG lasers are used in orthopedics, ophthalmology, otolaryngology,

cardiology, urology, oral/maxillofacial surgery, and pulmonary medicine.
Ho:YAG lasers emit energy near the absorption peak of water
(approximately 2,100 nanometers [nm]), they can cut or ablate tissue with
moderate hemostasis, little charring, and a thin zone of necrosis.
Ho:YAG energy is delivered through a small-diameter silica quartz fiber in
air or liquid that either contacts tissue or is a short distance away from it.
Ho:YAG laser fiber can be more readily maneuvered than a carbon dioxide
(CO2) laser delivery device to perform procedures in the gastrointestinal
tract, such as removal of sessile polyps.
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Diode Lasers
High-power surgical diode lasers are used to cut or vaporize

soft tissue with hemostasis and to photocoagulate soft tissue
in surgical specialties such as general surgery,
gastroenterology, gynecology, neurology, otorhinolaryngology,
plastic surgery, and urology.
At lower power settings, surgical diode lasers have been used
for interstitial laser photocoagulationa minimally invasive
technique for tumor destructionand various tissue-welding
applications.
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Ophthalmic Lasers
Photocoagulating ophthalmic lasers use argon, dye, krypton, diode, and

frequency-doubled Nd:YAG lasers to coagulate abnormal vascular tissue in
the retina.
Photodisrupting ophthalmic lasers or Q-switched Nd:YAG ophthalmic lasers

are used to perform microsurgery in the anterior portions of the eye,
primarily for posterior capsulotomy, but also for iridotomy, iridectomy,
transscleral cyclophotocoagulation, laser trabeculoplasty, anterior vitreolysis,
and pupillary membranectomy.
Photoablating ophthalmic lasers or Excimer (a contraction of excited

dimer) lasers are used in phototherapeutic keratectomy (PTK) to smooth
over corneal scarring and remove calcification plaques, in photorefractive
keratectomy (PRK) to shape the cornea to correct myopia (nearsightedness),
and in automated lamellar keratoplasty to correct both myopia and
hyperopia (farsightedness).
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Distinction between X and Gamma Rays

Gamma rays are the photons
generated from nuclear decay or
other nuclear and subnuclear/particle
process
X-rays are generated by electronic
transitions involving highly energetic
inner atomic electrons
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EM waves are typically described by any of the following three

physical properties:
Frequency (f) - Frequencies range from 2.4x1023 Hz down to tiny fractions of

Hertz (nanohertz for astronomical scale waves)
Wavelength () - Wavelength is inversely proportional to the wave frequency,

so gamma rays have very short wavelengths that are fractions of the size of
atoms, whereas wavelengths can be as long as the universe
Photon energy (E) - Photon energy is directly proportional to the wave

frequency, so gamma rays have the highest energy (around a billion electron
volts) and radio waves have very low energy
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The relationship between Frequency,

Wavelength and Photon Energy is:
Given the following:
c = 299,792,458 m/s (speed of light in vacuum)

h = 6.62606896(33)1034 Js (Planck's constant)
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Infection Control
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PATHOGEN: a microorganism that can cause disease
Examples of Illnesses Pathogens Cause

Viruses
AIDS, Hepatitis B, colds, flu, Herpes
Bacteria
Intestinal diseases, Tuberculosis,

Gonorrhea
Fungi
Athletes foot, Farmers lung,

Asthma/allergies
Parasites
Giardiasis, Malaria, Trichinosis
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E. coli (bacteria)
Trichinella (parasite)
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Bloodborne Pathogens (BBPs)
Present in
Blood
or
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Other
Potentially
Infectious
Materials
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Bloodborne Pathogens (BBPs)

Other Potentially Infectious Materials
OPIM
semen
vaginal secretions
body fluids such as pleural,
cerebrospinal, pericardial,
peritoneal, synovial, and
amniotic
saliva in dental procedures

(if blood is present)
any body fluids visibly
contaminated with blood
body fluid where it is
difficult to differentiate
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any unfixed tissue or

organ (other than
intact skin) from a
human (living or dead)
HIV- or HBVcontaining cultures

(cell, tissue, or organ),
culture medium, or
other solutions
blood, organs, &
tissues from animals
infected with HIV, HBV,
or BBPs
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Transmission of BBPs
Bloodborne Pathogens can enter your body through
A break in the skin (cut, burn, lesion, etc.)

Mucus membranes (eyes, nose, mouth)
Sexual contact
Other modes
Risk of infection depends on several factors:
The pathogen involved

The type/route of exposure
The amount of virus in the infected blood at the time of exposure
The amount of infected blood involved in the exposure
Whether post-exposure treatment was taken
Specific immune response of the infected individual
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Viral Hepatitis
Virus attacks liver inflammation, enlargement, and tenderness
Acute and chronic infections
Possible liver damage ranging from mild to fatal
The liver is a large, dark red gland located in the upper right abdomen behind the
lower ribs. It functions in removing toxins (poisons) from the blood, in the
digestion of fats, and in other body processes
Hearty - can live for 7+ days in dried blood
100 times more contagious than HIV
Approximately 78,000 new infections per year :
There are 370 million people world wide living with
5,000 deaths/year in US
No cure, but there is a preventative vaccine
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HCV - Hepatitis C
The most common chronic bloodborne infection in the U.S.
3.9 million (1.8%) Americans infected; 2.7 million chronically infected
25,000 new infections per year (2001)
Leading cause of liver transplantation in U.S.
8,000-10,000 deaths from chronic disease/year
No broadly effective treatment
No vaccine available
HCV Transmission
Injecting drug use

Hemodialysis (long-term)
Blood transfusion and/or organ transplant before 1992
From infected mother to child during birth
Occupational exposure to blood - mostly needle-sticks
Sexual or household exposures - rare
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Healthy human
liver
Hepatitis C liver
Copyright 1998 Trustees of Dartmouth College
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Reducing Your Risks
Universal precautions
Equipment and Safer Medical Devices
Work practices
Personal protective equipment
Housekeeping
Laundry handling
Hazard communication
Labeling
Regulated Waste
Universal Precautions
TREAT ALL HUMAN BLOOD AND OPIM AS IF KNOWN TO BE
INFECTIOUS WITH A BLOODBORNE DISEASE
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Safe Work Practices

Dont bend, recap, or remove needles or other sharps
Dont shear or break needles
Place contaminated reusable sharps immediately in appropriate
containers until properly decontaminated
Do not pipette or suction blood or OPIM by mouth
Wash hands after each glove use and immediately or ASAP after
exposure
Remove PPE before leaving work area
Do not eat, drink, smoke, apply cosmetics or lip balm, or handle
contact lenses in any work areas where there is the possibility
of exposure to blood or OPIM
Do not place food or drink in refrigerators, freezers, shelves,
cabinets, or on countertops or bench tops in any work areas
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Safe Work Practices

Wear protective eyewear and mask if splashing is anticipated
Remove glass and other sharps materials using a brush and dust pan, forceps,
hemostat; do not use your hands
Properly discard all materials into a sharps or puncture-resistant
biohazardous waste container
Use paper/absorbent towels to soak up the spilled materials
Clean the area with 10% bleach or EPA-registered disinfectant
Saturate the spill area with disinfectant. Leave for 10 minutes (or as specified
by product manufacturer) or allow to air dry
Properly dispose of paper towels and cleaning materials into proper waste
containers
You must wear all required PPE the hospital provides you
Gloves
Shoe covers
Resuscitation devices
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Lab coats
Gowns
Face shields or Masks and eye protection
Communication of Hazards
Biohazard Labels and Signs
Must have biohazard symbol
Labels attached securely to any containers or items
containing blood/OPIM
Red bags/containers may substitute for labels
Signs posted at entrance to specified work areas
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Exposure Incident
If you have an exposure incident to blood or OPIM, immediately do
the following:
Thoroughly clean the affected area

Wash needle-sticks, cuts, and skin with soap and water
Flush with water splashes to the nose and mouth
Irrigate eyes with clean water, saline, or sterile irritants
Report exposure to (supervisor, person or department responsible for
managing exposures, etc.); your supervisor will complete and submit the
Report of Occupational Injury or Disease
Post-exposure Evaluation - Institution Responsibility

Provide immediate (within 3 hours) post-exposure medical
evaluation and follow-up to exposed employee:
At no cost
Testing for HBV, HCV, HIV
Confidential
Preventive treatment when indicated
Test blood of source person if HBV/HCV/HIV status unknown, if

possible; provide results to exposed employee, if possible
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Post-exposure Evaluation - Institution Responsibility

Provide immediate (within 3 hours) post-exposure medical evaluation and
follow-up to exposed employee:
At no cost
Testing for HBV, HCV, HIV
Confidential
Preventive treatment when indicated
Test blood of source person if HBV/HCV/HIV status unknown, if possible;

provide results to exposed employee, if possible
Confidential
Hepatitis B vaccination and post-exposure evaluations
Health Care Providers (HCP) written opinions
Information provided to HCP as required
Maintain for length of employment + 30 years
Provide exposed employee with copy of the evaluating health care
professionals (HCP) written opinion within 15 days of completion of
evaluation
Provide employee with information about laws on confidentiality for the
source individual
Provide post-exposure treatment as needed, including counseling
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Fire Safety
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Fire Triangle
The fire triangle is a simple model for understanding the

ingredients necessary for most fires.
The triangle illustrates the rule that in order to ignite
and burn, a fire requires three elements
Heat
Fuel
Oxygen
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59
Fire Tetrahedron
A fire tetrahedron is a triangular pyramid having four

sides (including the bottom).
In most fires, it does not matter which element gets
removed; the fire fails to ignite, or it goes out.
However, there are certain chemical fires where knowing
only the
fire triangle is not good enough.
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60
Fire Tetrahedron
Combustion is the chemical reaction that feeds a fire more

heat and allows it to continue.
With most types of fires, the old fire triangle model works
well enough, but when the fire involves burning metals
(lithium, magnesium, etc.), it becomes useful to consider
the chemistry of combustion.
Putting water on such a fire could result in the fire getting
hotter (or even exploding) because such metals can react
with water in an exothermic reaction to produce
flammable hydrogen gas.
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61
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62
Stopping Fire
A fire is prevented or extinguished by removing any one of
the sides of the triangle
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63
Fuel
A fire will not start and will run out when there is no fuel.
Fuel can be removed from a fire when:
Fire has consumed all the burnable fuel
Intervening with the fire and removing it manually by
mechanical or chemically
Some fuels may be chemically altered to prevent them
from burning at ordinary temperatures, a fireprevention measure
Example: ETO 12/88 mixture.
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64
Heat
Without sufficient heat, a fire cannot begin, and it cannot

continue.
Heat can be removed by dousing some types of fire
with water, as the water turns to steam, taking the
heat with it.
Water on some types of fires will actually increase or
spread the fire, such as oil and grease fires.
Separating burning fuels from each other can also be
an effective way to reduce the heat.
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65
Oxygen
Oxygen may be removed from a fire by smothering it with:
an aqueous foam (fire extinguisher)

inert gas (carbon dioxide, Halon)
dry chemicals (ABC fire extinguisher)
enclosing it where the fire will quickly use up all of the available
oxygen (A candle snuffer)
Oxygen for the fire may also be instantaneously

consumed, if only for a moment, by more sophisticated
means such as using explosives to snuff an oil well gas fire.
Once the gas fire is out, it is not hot enough to start again,
but workers must be extremely careful not to create
sparks!
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Fire Extinguisher Types

Fire extinguishers are classified according to
National Fire Protection Association
(NFPA) standards as illustrated below.
Class A: For wood, paper, cloth, and

most plastics
Class B: For flammable liquids or grease
Class C: For energized electrical
equipment
Class F: For flammable gases
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Fire Extinguisher Operation

P.A.S.S.
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68
RACE defines the actions that should take place:
Rescue the patient if possible

Alert staff in nearby O.R.s and Activate fire alarm
systems
Confine the smoke and fire by shutting all doors and

closing off gas, vacuum, and power systems
Evacuate the O.R. and, if necessary, the surgical suite.
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Number of Surgical Fires a Year in the U.S.
ECRI estimates that 50 to 100 or more surgical fires occur

each year in the United States alone. *1
Types of Equipment Involved in the Surgical Fire*1

About 70% of surgical fires involve electrosurgical (Bovie)
equipment as the ignition source.
Another 10% involve lasers.
The balance of fires are ignited by a variety of other heat
sources, including electrocautery (hot-wire cauterization)
equipment, fiberoptic light sources, defibrillators, and highspeed burs (which can produce sparks).
*1 Surgical Fire Safety, Health Devices, February 2006, www.ecri.org
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Oxidizers and Fuels *1

Oxygen-enriched atmospheres are
reportedly involved in about 75% of
surgical fires.
Alcohol-based surgical preps are
involved in about 4% of reported
fires.
Patient Burn Location *1

About 21% of reported fires occur in the
airway
44% occur on the head, neck, or upper
chest;
26% occur elsewhere on the patient
8%Surgical
occur Fire
elsewhere
in the
patient
*1
Safety, Health
Devices,
February 2006, www.ecri.org
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Fire Extinguisher Types Carbon Dioxide
A 5 lb carbon dioxide (CO2) fire extinguisher is the best choice for

putting out fires typically encountered in ORswhere the patient is the
primary concern.
Despite their Class BC rating, CO2 extinguishers can be used to

extinguish small masses of cloth, plastic, or paper (Class A) involved in
patient fires, as well as any flammable liquid (Class B) or electrically
energized (Class C) fires that could occur in the OR.
Equally important, these extinguishers do not leave residue and will not
harm the patient, staff, or equipment.
A 5 lb capacity CO2 extinguisher weighs approximately 7 to 9 kg (15 to

20 lb), fits in a space approximately 23 x 23 x 36 cm (9 x 9 x 14 in), and is
easily handled by most people. For easy access, the extinguisher should
be mounted inside the OR near the entrance.
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Fire Extinguisher Types Dry Powder
Class ABC-rated fire extinguishers are not appropriate for use in the OR.
These models disperse a cloud of fine, dry powder (usually ammonium

phosphate) that extinguishes the fire.
This cloud contaminates all surfaces in the OR, including the patient and
any surgical wounds.
In addition, the powder is a respiratory irritant, which could affect the

staff's ability to aid the patient, is hard to remove from wounds, and
requires that all contaminated equipment be thoroughly cleaned.
While dry powder extinguishers should be available in the OR suite

(outside individual ORs), they should be used in the OR only as a last
resort.
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Fire Extinguisher Types Halon
Halon extinguishers, which are no longer available

because of environmental concerns, had been a
better choice for use in the OR than CO2
extinguishers.
These units have a unique fire extinguishing action
and a low weight, making them easy to use.
Halon extinguishers that are still in service will
continue to provide protection; however, once
used, they cannot be recharged.
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Fire Extinguisher Types Pressurized Water

Pressurized-water (PW) fire extinguishers are available, but they are
heavy and are chiefly effective against Class A fires.
Using a PW extinguisher is more difficult than using a Halon or CO2
device.
To extinguish burning water-repellent drapes with a PW fire
extinguisher, users must place a finger partially over the end of the
nozzle to produce a fine spray.
Water in a stream or tossed from a pan can fan the flames and increase
a drape fire.
Water from corridor-located fire hoses typically spray 50 gallons of

water a minute and can be effective as a last resort when immediate
rescue or evacuation is needed.
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Fire Extinguisher Types Water (sterile)
Water as a fire-extinguishing agent can be used over a wide

range of fires.
However, a fire involving energized electrical equipment,
although rare in the OR, should not be extinguished with
water, but with an extinguisher rated for Class C fires.
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Fire Extinguisher Types Sprinkler Systems
Found in newer surgical suites.
May only activate with larger fires heat sensitive.
Water is not sterile, and is most likely stale, mineral concentrated

water, which would not be good for patients in sterile conditions.
Water can not be controlled or turned off easily, so the patient will have
to be relocated to another surgical suite.
Water will be spraying everywhere, so there is a greater risk of electrical

shock as electrically powered equipment will be coated with water.
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Fire Extinguisher Types Fire Hoses
Located in hallways or stairwells
Water is not sterile, and is most likely stale, mineral concentrated

water, which would not be good for patients in sterile conditions.
Water will be spraying everywhere, so there is a greater risk of electrical

shock as electrically powered equipment will be coated with water.
Water force can cause mechanical damage to the and be hard to

control.
Not a recommended method for fighting surgical fires.
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Regulatory
Organizations
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79
Regulations Organizations
Medical equipment manufacturers and health care organizations must be in
compliance with certain regulatory organizations as required by law.
Regulatory organizations would include all organizations at the federal, state
and local levels for healthcare organizations, medical manufacturers and
medical equipment service providers.
Failure to meet these requirements could have limited or loss of conducting
medical services, fines, jail sentences imposed on the organization. Some
state and local regulatory organizations may adopt select published
standards and use these as the basis of their regulations.
If this is the case, then these standards become requirements that healthcare
organizations must be in compliance with. That state or local regulatory
organization then becomes the authority having jurisdiction and can
enforce their requirements and standards.
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81
OSHA - Occupational Safety and Health Administration

The mission of the Occupational Safety and Health Administration
(OSHA) is to save lives, prevent injuries and protect the health of
the Americas workers. Some of the OSHA regulations that could
apply to medical equipment management are:
Electrical Safety - 1910.301

Confined Spaces - 1910.146
Lockout-Tagout - 1910.147
Portable Wood Ladders - 1910.25 .26 .119
Ethylene Oxide Monitoring 1910.1047
Formaldehyde Monitoring 1910.1048
Hazard Communication - 1910.1200
Acoustic Calibration of Audiometers - 1910.95 App E
Oxygen - 1910.104
Nitrous Oxide - 1910.105
Personal Protective Equipment - 1910.132
http://www.osha.gov
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Hospital eTool
http://www.osha.gov/SLTC/etools/hospital/mainpage.html
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Hazard Communication
A. Hazard Determination
Chemical manufacturer and importers
Employers not required to evaluate chemicals
B. Labels and Other Forms of Warning
Identity of the hazardous chemical
Appropriate hazard warnings
Name and address of chemical manufacturer, importer, or other
responsible party
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C. Material Safety Data Sheets (MSDS)
Each hazardous chemical used in work place
English
Employee accessible
Ingredients
Composition
Physical Data
Fire and Explosion Hazard Data
Environmental Information
Health Hazard Data
Precautionary Information
Shipping regulations
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85

D. Employee Information and Training
Initial Assignment
New hazard is introduced in work area
1. Information
a. Any operation in their work area where hazardous chemicals are present
b. Location and availability of written hazard communication program
2. Training
a. Methods and observations that may be used to detect the presence of release
of a hazardous chemical in their work area
b. Physical and Health Hazards of chemicals in work area
c. Measures employees can take to protect themselves from hazards
d. Details of hazard communication program including discussion of the labeling
system, MSDS, and how employees can obtain and use the appropriate hazard
information
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How does OSHA 1910.1200 Impact Clinical Engineering
Departments
A. Ordering Chemical
Demand MSDS
Verify upon delivery
B. Updated MSDS Inventory

Lubricants
Adhesive products
C. Training
Use
Disposal
Personal Protective Equipment
Cleaning agents
Mercury
Clean-up
Annual training
Spill clean-up materials
D. Hospital wide
Adhere to each department policy Know location of MSDS

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FDA Food and Drug Administration

Division - Center for Devices and Radiological Health
http://www.fda.gov/cdrh/index.html
FDA's Center for Devices and Radiological Health is responsible for

ensuring the safety and effectiveness of medical devices and
eliminating unnecessary human exposure to man-made radiation
from medical, occupational and consumer products. There are
thousands of types of medical devices, from heart pacemakers to
contact lenses. Radiation-emitting products regulated by FDA
include microwave ovens, video display terminals, and medical
ultrasound and x-ray machines.
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88

Pre-Market Notification - 510(k) Overview
Section 510(k) of the Food, Drug and Cosmetic Act requires those device
manufacturers who must register to notify FDA, at least 90 days in advance, of
their intent to market a medical device. This is known as Premarket
Notification - also called PMN or 510(k).
It allows FDA to determine whether the device is equivalent to a device already
placed into one of the three classification categories. Thus, "new" devices (not
in commercial distribution prior to May 28, 1976) that have not been classified
can be properly identified.
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Pre-Market Notification - 510(k) Overview
Specifically, medical device manufacturers are required to submit a premarket
notification if they intend to introduce a device into commercial distribution
for the first time or reintroduce a device that will be significantly changed or
modified to the extent that its safety or effectiveness could be affected. Such
change or modification could relate to the design, material, chemical
composition, energy source, manufacturing process, or intended use.
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90

Mammography Quality Standards Act (MQSA)
Congress enacted MQSA to ensure that all women have access

to quality mammography for the detection of breast cancer in
its earliest, most treatable stages.
The Mammography Quality Standards Act (MQSA) was enacted

in 1992.
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Mammography Quality Standards Act (MQSA)
Congress enacted MQSA to ensure that all women have access to quality
mammography for the detection of breast cancer in its earliest, most treatable
stages.
Interim regulations, issued in December 1993, became effective in February

1994.
In 1995, FDA began enforcing MQSA
On October 28, 1997, FDA issued more comprehensive final regulations, which
became effective on April 28, 1999. Three amendments to the regulations
have been published since they were first issued. These amendments have
been incorporated in the amended final regulations.
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Safe Medical Devices Act (SMDA)
I. INTRODUCTION
Under the Safe Medical Devices Act (the "Act"), health care facilities must report
serious or potentially serious device-related injuries or illness of patients
and/or employees to the manufacturer of the device, and if death is involved,
to the Federal Food and Drug Administration ("FDA").
In essence, the Act is intended to serve as an "early warning" system through
which the FDA can obtain important information on device problems.
Its provisions apply to all inpatient units, ambulatory surgical care units,
perioperative units, diagnostic units and outpatient treatment centers within
the Health System which are not designated physician offices. Failure to
comply with the Act will result in civil penalties.
The Act also requires that hospitals and health care workers report and track
required information regarding certain medical devices specified by the FDA
upon receipt, implanting and removal of the device.
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93

II. THE DUTY TO REPORT AND THE HEALTH SYSTEMS POLICY
All employees who are involved with patient care, review patient
care, repair devices or provide device preventative maintenance
have a duty under the Act to report device-related incidents (e.g.,
device failure, device malfunction, inadequate design or labeling
and user error).
This duty extends to physicians, nurses, allied health professionals,
students, volunteers and all other persons affiliated with the
facility.
Basically, anything that is not a drug is considered a device under
the Act. Examples include, but are not limited to, a(n): anesthesia
machine, pacemaker, heart valve, suture, surgical sponge,
wheelchair, hospital bed or gurney, catheter, infusion pump,
dialysis machine and artificial joint.
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When a device-related incident occurs, employees should:
Save the device, packaging and all related parts, and note the devices clinical
engineering number or serial number.
Place a "Defective . . . Do Not Use" tag on the device and remove it from use.
Notify the patients physician or refer the visitor to the Emergency Department or
refer the employee to Occupational Health.
Notify the department most appropriate to handle the device (e.g., Materials
Management Department, Physical Plant Department, Clinical Engineering
Department, Biomedical Engineering Department).
Telephone Risk Management immediately.
Complete an incident report and deliver it to Risk Management within twenty-four
hours following the occurrence.
The Risk Management office will file the report(s) with the manufacturer of the
device and/or the FDA. Since these reports must be filed within ten working
days of the date of the incident, prompt reporting to Risk Management is
essential.
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MedWatch form is what is

submitted to the FDA for any
reportable event.
Only The Patients Sex and Age

are submitted that are specific
to the incident, no other
traceable personal information
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96

Medical Device
A "device" is defined as an instrument, apparatus, contrivance, implant, in vitro reagent,
or other similar or related article, including any component, part, or accessory, which is -
(1) recognized in the official National Formulary, or in the United States Pharmacopeia, or
any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or animals, and which
does not achieve its primary intended purpose through chemical action within or on the
body of man or other animals and which is not dependent upon being metabolized for
the achievement of any of its intended principal purposes (21 U.S.C. 32{h}).
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Serious Illness and Serious Injury.

(1) Life-threatening;
(2) results in permanent impairment of a body function or permanent
damage to a body structure; or
(3) necessitates medical or surgical intervention to preclude permanent
impairment of a body function or permanent damage to a body structure.
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Caused or contributed
Means that a death or serious injury was or may have
been attributed to a medical device, or that a medical
device was or may have been a factor in a death or
serious injury, including events occurring as a result of:
(1) Failure;
(2) Malfunction;
(3) Improper or inadequate design;
(4) Manufacture;
(5) Labeling; or
(6) User error.
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Time Requirements
10 working days & Semiannual Reports
User Error
The improper administration or incorrect
technique on the part of the clinician.
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100

III. MEDICAL DEVICE IMPLANT TRACKING
The Act requires that hospitals report and track certain information regarding
medical devices specified by the FDA. These devices are primarily medical
devices that are permanently implanted in a patient or certain life-sustaining
or life-supporting devices used outside of the hospital.
The designated devices include, for example, vascular grafts, ventricular bypass
devices, pacemakers, implantable infusion pumps, apnea monitors and certain
silicone gel-filled prosthesis. (For a more detailed list of devices, please refer
to the hospitals policy on Safe Medical Devices Act Medical Devices Implant
Tracking).
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III. MEDICAL DEVICE IMPLANT TRACKING
The Act requires that receipt of tracked devices be reported to the

manufacturer and that patient demographic and medical
information be reported to the manufacturer upon implanting or
use of the device within five working days. This enables the
manufacturer to trace specified medical devices to patients and
to facilitate patient notification and/or device recall.
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DOH Department of Health

Examples of key functions of State DOH include:
Health Care Facility Licensing

Medicaid health care coverage for people with limited incomes
Mental health services for people who have a mental illness or a
developmental disability, and services for people who need care for
substance abuse
Health needs assessment, health promotion, disease prevention, and
accessibility to appropriate health care for all citizens
Drug law enforcement, treatment, education and prevention programs
Monitor the health status of the population
Identify and eliminate preventable illness and accidents
Reduce the severity of illness and disability
Promote healthy behaviors
Improve health care quality, access, continuity and accountability
Lead the development of sound health policy and planning.
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104
FCC Federal Communications Commission

The Federal Communications Commission (FCC) is an independent
United States government agency, directly responsible to
Congress.
The FCC was established by the Communications Act of 1934 and is
charged with regulating interstate and international
communications by radio, television, wire, satellite and cable.
The FCC's jurisdiction covers the 50 states, the District of
Columbia, and U.S. possessions.
Regulates Wireless Medical Telemetry Service (WMTS)
ASHE is the agency responsible for registration of telemetry
frequencies
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EPA Environmental Protection Agency

The mission of the Environmental Protection Agency is to protect human health
and the environment. Examples of compliance issues regarding medical
equipment management could include:
Battery Disposal
NiCad
Lead Acid
Jell Cell
Mercury Disposal
Hazardous Chemicals
Cleaning Agents
High Voltage Dielectric Oil (X-ray)
Lubricants & Oils
ETO & Formaldehyde
Lead & Other Metals for Disposal
X-Ray Tubes
Fluorescent Lights
Freon
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NRC - U.S. Nuclear Regulatory Commission

What We Do
NRC's primary mission is to protect the public health and safety, and the
environment from the effects of radiation from nuclear reactors,
materials, and waste facilities. We also regulate these nuclear materials
and facilities to promote the common defense and security. NRC carries
out its mission by conducting the following activities:
Commission Direction-Setting and Policymaking - policy formulation,
rulemaking, and adjudication oversight activities performed by NRC's fivemember Commission.
Radiation Protection - information about radiation and NRC's role in
ensuring protection of the public and radiation workers.
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Health Insurance Portability and Accountability Act of 1996 (HIPAA)

HIPAA became public law 104-191 and consists of 5 sections:
1. Title 1 Health Care Access, Portability and Renewability
2. Title II Preventing Health Care Fraud and Abuse; Administrative
Simplification; Medical Liability Reform
3. Title III Tax-Related Health Provisions
4. Title IV Application and Enforcement of Group Health Plan
Requirements
5. Title V Revenue Offsets
Of the five sections, Title II, has the greatest impact on day-to-day medical
operations and service, as it deals with:
Patient consent and patient access to medical records
Electronic transactions
Privacy
Security of data
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Standards
Organizations
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109
Standard Organizations
Medical equipment manufacturers may work with other manufacturers and professional
organizations to develop equipment standards, so there are consistent safety,
labeling, operation, patient connections and outputs of medical devices regardless of
the manufacturer.
Hospitals may develop their own specific equipment management methods based from
their own needs, talents and skills of individuals, financial restraints and risk-based
decisions.
There are however, many different standards that give guidance to implementing,
managing and monitoring a medical management program.
Standard organizations are typically national, state or local professional organizations
comprised of volunteers (who are recognized as leaders in their field) that write
specific statements on how medical equipment should be designed, labeled,
assembled, tested, and maintained.
Healthcare organizations can create their own policies and procedures by the use of
standard organization publications for making decisions, with oversight by the safety
committee, risk management department or administration for approving their
decisions.
In some cases, the local authority having jurisdiction may adopt one or more standards
as the basis of their regulatory requirements, which at that point the standard
becomes regulatory for that organization. This could be at the state, county, city or
borough level for that particular healthcare organization.
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JC Joint Commission
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110
JC Joint Commission
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111
JC Joint Commission
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112
JC Joint Commission
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114
JC Joint Commission
The hospital has a written plan for managing the following: Medical
equipment. (See also EC.04.01.01, EP 15)
The hospital responds to product notices and recalls. (See also MM.05.01.17,
EPs 1-4)
The hospital solicits input from individuals who operate and service equipment
when it selects and acquires medical equipment.
The hospital maintains either a written inventory of all medical equipment or a

written inventory of selected equipment categorized by physical risk
associated with use (including all life support equipment) and equipment
incident history. The hospital evaluates new types of equipment before initial
use to determine whether they should be included in the inventory. (See also
EC.02.04.03, EPs 1 and 3)
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JC Joint Commission
The hospital identifies the activities in writing for maintaining,

inspecting and testing for all medical equipment on the
inventory. (See also EC.02.04.03, EPs 2 and 3)
The hospital identifies in writing frequencies for inspecting,

testing, and maintaining medical equipment on the inventory
based on criteria such as manufacturers recommendations, risk
levels, or current hospital experience. (See also EC.02.04.03, EPs 2
and 3)
The hospital monitors and reports all incidents in which medical

equipment is suspected in or attributed to the death, serious
injury, or serious illness of any individual, as required by the Safe
Medical Devices Act of 1990.
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JC Joint Commission
The hospital has written procedures to follow when medical equipment fails, including
using emergency clinical interventions and backup equipment.
Before initial use of medical equipment on the medical equipment inventory, the
hospital performs safety, operational, and functional checks. (See also EC.02.04.01, EP
2)
The hospital inspects, tests, and maintains all life support equipment. These activities
are documented. (See also EC.02.04.01, EPs 3 and 4 and PC.02.01.11, EP 2)
The hospital inspects, tests, and maintains non-life support equipment identified on
the medical equipment inventory. These activities are documented. (See also
EC.02.04.01, EPs 2-4 and PC.02.01.11, EP 2)
The hospital conducts performance testing of and maintains all sterilizers. These
activities are documented. (See also IC.02.02.01, EP 2)
The hospital performs equipment maintenance and chemical and biological testing of
water used in hemodialysis. These activities are documented.
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JC Joint Commission
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JC Joint Commission
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119
American Association of Blood Banks (AABB)

The AABB is a United States-based professional body and standards
organization that was founded in 1947 as the American
Association of Blood Banks.
The organization is now international with members in 80
countries and has taken on a broader scope to include all of
transfusion medicine as well as cellular therapies, specifically
ones based on hematopoietic stem cells.
AABB works closely with the US Food and Drug Administration and
provides technical input into the development of blood
regulations for the US.
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American Association of Blood Banks (AABB)

Membership is not a regulatory requirement, virtually all major
blood banks in the United States are accredited by the AABB.
More than 80 percent of hospital transfusion services and similar
facilities in the US are members.
Accreditation by AABB meets the requirements of the Clinical
Laboratory Improvement Amendments (CLIA) for blood bank,
transfusion service, and immunohematology reference
laboratory operations.
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NFPA National Fire & Protection Agency

NFPA 99 Health Care Facilities Handbook 2012
http://www.nfpa.org
http://www.nfpa.org/aboutthecodes/aboutthecod
es.asp?docnum=99
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Are Operating Rooms Wet Locations? An ongoing NFPA 99 debate focuses
on the issue of whether operating rooms need additional protectionat
additional expenseagainst electrical shock
NFPA Journal, January/February 2010
By Richard P. Bielen, P.E.
One of the key areas of debate in last years discussion of NFPA 99, Health Care
Facilities, centered around the topic of "wet locations." The current 2005 edition of
NFPA 99 requires operating rooms and other potential wet locations in hospitals to
have special protectionusually either isolated power-supply systems or ground-fault
circuit interrupters (GFCIs)against electrical shock.
There are two opposing schools of thought on this, and the discussion is far from over.
The proposed 2010 edition of NFPA 99 was returned to the Technical Committee at
last years Technical Session at the NFPA Conference & Expo, and, as a result, the
Technical Correlating Committee has entered the document in the Annual 2011 cycle.
This means the next edition of NFPA 99 will be the 2012 edition. It also gives
committee members that much more time to engage in the wet locations debate.
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Historically, the standard has not specified which areas are
considered wet locations, instead specifying areas that are not
required to be considered wet-procedure locations, such as
patient beds, toilets, bidets, and wash basins. The proposed
2010 edition changed all that, however. The term "wet
location" was changed to "wet procedure location" to
differentiate it from the definition found in NFPA 70, National
Electrical Code, and in the Report on Proposals (ROP) the
technical committee proposed the following change to the
definition of wet locations to include operating rooms:
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124
"3.3.185* Wet Locations. The area in a patient care area where a

procedure is performed that is normally subject to wet
conditions, including all operating rooms, while patients are
present, including standing fluids on the floor or drenching of
the work area, either of which condition is intimate to the
patient or staff.
A.3.3.185 Wet Locations. Routine housekeeping procedures do

not define a wet location. Spillage of liquids in an operating
room location where surgery is performed is considered a wet
location.
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This now meant that in new construction and
renovations, operating rooms would be required to
have special protection against electrical shock. Existing
construction would not have to meet this requirement
if written inspection procedures, acceptable to the
authority having jurisdiction, were continuously
enforced and if the electrical system were installed and
maintained in accordance with NFPA 70. This proposal
was debated by the committee and passed the written
ballot.
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Medical Gas & Vacuum
Oxygen (Green)
Medical Air (Yellow)
Nitrous Oxide (Blue)
Carbon Dioxide (Grey)
Nitrogen (Black)
Helium (Brown)
Vacuum (White)
Waste Anesthetic
Disposal (Violet)
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Gas

Electrical Safety
Current limits Below are the NFPA 99 (2012) recommended
leakage current limits.
Portable Equipment, Touch Current
Chassis, 100 ua with the ground wire intact
Chassis, 500 ua with the ground wire disconnected
Portable Equipment, Lead Leakage Current, All leads connected

together, power normal and on
100 ua with ground wire
500 ua with open ground wire
Fixed Equipment, Leakage Current

10 ma on ground conductor
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128

Electrical Safety
Leakage current
Current limits - are measued in the following
configurations:
Device ground
Device power
Device polarity (hot/nueutral)
OPEN
ON
NORMAL
CLOSED
OFF
Record the highest measured leakage current and the configuration

(ON/Off, Ground OPEN/CLOSED and Polarity NOR/REV)
V14

Electrical Safety
Grounding
Why it is necessary Provides the least amount of resistance for
leakage current to flow back to the power source.
Current will always take the least path of resistance.
Leakage current exists in all electrically powered devices, therefore a
ground is required to remove the current.
Ground conductor is also required for faults or failures with the device
so currents have a safe path to follow.
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130

Electrical Safety
Grounding
Where it is measured from the device chassis to the ground pin of the
power plug.
If possible, the plug should be removed from the receptacle with the
power off.
If the device is hard wired, the ground can still be measured from the
metal chassis to a ground on the electrical distribution system
(power off).
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131

Electrical Safety
Grounding
Measurement limits the maximum grounding resistance should not be
greater that 0.5 ohms.
While measuring, the power cord should be twisted and moved at the
strain relief to the device and at the power plug to check for loose
connections.
Redundant grounds should be removed if the device can not be
unplugged.
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Oxygen (Green)
Medical Air (Yellow)
Nitrous Oxide (Blue)
Carbon Dioxide (Grey)
Nitrogen (Black)
Helium (Brown)
Vacuum (White)
Waste Anesthetic
Disposal (Violet)
V14
Gas

Common Brands of Quick Connectors
Ohio Male Diamond Type Quick Connect
Male Chemetron Quick Connect (NCG)
Puritan DISS Diameter Index Safety System

Schrader
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133
Pin Index
Safety
System
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135
Oxygen
V14
Nitrous Oxide

Gas Supply
House Gas Supply (recommended)
Oxygen (Green) - 50 PSI
Medical Air (Yellow) 50 PSI
Nitrous Oxide (Blue) - 50 PSI
Cylinder Gas Supply

Oxygen (Green) 2200 full 500 replace
Nitrous Oxide (Blue) 745 full 0 replace
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136

Medical Air System
Dual Compressors
Lead-Lag Setting
Oil Free Compressors
Dry Air (refrigeration)
Filter Air (Particulates)
Dew Point Monitor
Carbon Dioxide Monitor
High/Low Pressure Alarms
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137

Vacuum System
Compressor & Back-Up
Lead-Lag Setting
Low Vacuum Alarms
Exhaust away from
air intakes
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139

Bulk Oxygen System
Liquid Oxygen in Bulk Storage Tank (Horz or Vert) (~ -200 F)
Reserve Liquid Bulk Storage (if primary were exhausted)
Vaporizers add environmental heat to expand molecules and convert
liquid to gas
Exit pressure of vaporizers ~ 120 PSI (temperature dependent)
Primary pressure regulator steps pressure down to ~ 90 PSI
Secondary pressure regulator steps pressure down to 50 PSI
Liquid Level Alarms (High, Low, Order Points)
Gas Pressure Alarms (High/Low)
Located outside facility on concrete
V14

Bulk Oxygen System
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141

Nitrous Oxide System
2 Banks of N2O cylinders with switch/control unit
Gas supply is drawn from one bank at a time, as volume of gas can
not be calculated by pressure as N2O is always 745 PSI when liquid
is available
When cylinders deplete all liquid, gas pressure will drop quickly and
the switch/control unit will connect the other cylinder bank to the
building
A Reserve in Use Alarm will activate till all exhausted cylinders are
replaced
Gas Pressure Alarms (High/Low)
System is located outside facility, normally in enclosed building
V14

Nitrous Oxide System
V14
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143

Piping Labeling Requirements
NFPA 99 Section 5.1 requires that all pipes carrying
medical gas must be permanently labeled with their
contents, direction of flow, and pressure (if between
200 and 300 psi). The text of the label should run
parallel to the pipe and must be at least 3/8" tall. The
table above shows the standard colors and designations
established by the code.
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144

Piping Labeling Requirements
Labels must appear in the following locations:
At intervals of 20' or less

At changes of direction
Before and after barriers
At inlets and outlets
Vertically, at every floor
On access doors to enclosures containing piping, valves, or other
medical gas components.
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145

System Testing
Alarm testing Bulk system, pressure, reserve systems,
CO2, dew point, master & remote alarms
Gas Pressure, flow, concentration/accuracy,
particulate, labeling, fitting connections
Shut Off Values Labeling, performance
V14
146

System Testing
Excellent document that summarizes the testing of
medical gas systems
http://212.1.214.36/pluginfile.php/1566/mod_resource
/content/1/NFPA%20Summary%20%20Environmental%20Monitoring%20Technology.htm
V14
147
ASHE American Society for Healthcare

Engineering
ASHE's Mission is Dedicated to optimizing the healthcare physical
environment. ASHE works directly with the NFPA and The Joint
Commission in creating, reviewing, interpreting and education of
users in these standard areas. Even though ASHE has a primary
focus on the healthcare physical plant, many of the standards
must be understood and cross over into the medical equipment
management area.
http://www.ashe.org
V14
AAMI Association for the Advancement of

Medical Instrumentation
Leakage current standards

Department operation
Manufacturer standards
Sterilization standards
Hemodialysis standards
http://www.aami.org
V14
148
149
ECRI Institute
ECRI Institute is a nonprofit health services research agency and a Collaborating
Center of the World Health Organization (WHO). It is designated as an
Evidence-based Practice Center (EPC) by the U.S. Agency for Healthcare
Research and Quality. ECRI's mission is to improve the safety, quality, and
cost-effectiveness of healthcare. It is widely recognized as one of the world's
leading independent organizations committed to advancing the quality of
healthcare.
ECRI Institute focus is healthcare technology, healthcare risk and quality
management, patient safety improvement and healthcare environmental
management. It provides information services and technical assistance to
more than 5,000 hospitals, healthcare organizations, ministries of health,
government and planning agencies, voluntary sector organizations,
associations, and accrediting agencies worldwide. Its more than 30 databases,
publications, information services, and technical assistance services set the
standard for the healthcare community.
http://www.ecri.org/
V14
150
CAP College of American Pathologists

The CAP Laboratory Accreditation Program is an internationally
recognized program and the only one of its kind that utilizes
teams of practicing laboratory professionals as inspectors.
Designed to go well beyond regulatory compliance, the program
helps laboratories achieve the highest standards of excellence to
positively impact patient care.
http://www.cap.org/apps/cap.portal
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151
UL - Underwriters Laboratories
UL has developed more than 800 Standards for Safety. Their
Standards for Safety are essential to helping ensure public safety
and confidence, reduce costs, improve quality and market
products and services. Millions of products and their
components are tested to ULs rigorous safety standards with
the result that consumers live in a safer environment than they
would have otherwise.
http://www.ul.com/
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152
CSA International
CSA International-a leading provider of product testing and
certification services.
We test products for compliance to national and international
standards, and issue certification marks for qualified
products. Certification marks tell potential customers and
users that a product has been evaluated by a formal processinvolving examination, testing and follow-up inspection-and
that it complies with applicable standards for safety and
performance.
http://www.csa-international.org
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153
Institute of Electrical and Electronics Engineers

(IEEE)
An association dedicated to advancing innovation and
technological excellence for the benefit of humanity, is
the worlds largest technical professional society.
It is designed to serve professionals involved in all aspects
of the electrical, electronic, and computing fields and
related areas of science and technology that underlie
modern civilization.
V14
ANSI American National Standards Institute

Creates a wide set of standards for many industries, but those
specific to clinical engineering departments would include:
Medical gases (in general)
Cylinders for medical gases
Fittings & connectors for medical gases
Labeling & color coding for medical gases
Piping, tubing and hoses for medical gases
Medical gas distribution components regulators, valves,
fittings, pressure gauges, flow meters,...
Fixed and portable gas delivery systems
Safety and handling for medical gases
V14
154
155
AIA American Institute of Architects

The AIA is a membership society that provides published standards in many
different industries, including healthcare. For clinical engineering
departments, these documents can give coordinated direction for new
construction or renovation within the hospital so that industry standards are
met or exceeded. Some examples would be:
Area requirements (ft2)
Plumbing
Lighting levels
Shielding
Noise
Patient privacy issues
Floor Loading
Room/area requirements
Electrical
Communications
Mechanical
Contractor bid requirements
Medical Gases
Life safety
V14
156
ISO - International Organization for

Standardization
ISO (International Organization for Standardization) is the world's largest developer of standards. ISO
standards make a positive difference, not just to engineers and manufacturers for whom they
solve basic problems in production and distribution, but to society as a whole.
ISO standards contribute to making the development, manufacturing and supply of products and
services more efficient, safer and cleaner. They provide governments with a technical base for
health, safety and environmental legislation. They aid in transferring technology to developing
countries. ISO standards also serve to safeguard consumers, and users in general, of products
and services - as well as to make their lives simpler.
http://www.iso.org
V14
157
DICOM Digital Imaging and Communications in

Medicine
The DICOM Standards Committee exists to create and maintain international
standards for communication of biomedical diagnostic and therapeutic
information in disciplines that use digital images and associated data.
DICOM is a cooperative standard. Connectivity works because vendors
cooperate in testing via either scheduled public demonstrations, over the
Internet, or during private test sessions. Every major diagnostic medical
imaging vendor in the world has incorporated the standard into its product
design, and most are actively participating in the enhancement of the
Standard. Most of the professional societies throughout the world have
supported and are participating in the enhancement of the standard as well.
V14

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Safety in the

Health Care Facility

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

F. Codes and Standards

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

Classes of Medical Devices

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

Body can sense shock.

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

NFPA 99 National Fire

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

Portable Equipment, Touch Current

Portable Equipment, Lead Leakage Current, All leads

Fixed Equipment, Leakage Current

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

Record the highest measured leakage current and the configuration

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

Power Plugs & Outlets

Hospital Grade - Green Dot

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

Power Plugs & Outlets

Normal Power Outlets - Ivory/Brown

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

Power Plugs & Outlets

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

120 Volt Receptacle Testing

Ground to Ground resistance

Ground to Neutral resistance

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

Emergency Generator Testing

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

Classifications of EM radiation is by wavelength

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

Classifications of EM radiation is by wavelength

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

Classifications of EM radiation is by wavelength

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

Classifications of EM radiation is by wavelength

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

Classifications of EM radiation is by wavelength

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

Classifications of EM radiation is by wavelength

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

Absorption Coefficient A factor in determining the ability of light to be absorbed.

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

Eximer a method of using a gas mixture as the basis of emitting ultraviolet

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

Laser Safety Officer is an authorized individual who has the responsibility

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM

Optical Cavity is required to provide the amplification desired in the laser

CBET REVIEW SAFETY IN THE HEALTHCARE FACILITY BIOMED-ED.COM