Zentr Steril 2009; 17 (4): 245–256
Keywords
• instrument reprocessing
• alkaline cleaning
• ophthalmology
• material effects
• functionality
Investigation of Alkaline Detergents for
Automated Reprocessing of Ophthalmic Surgery
Instruments in Terms of Material Compatibility
and Alkaline Residues
The ”vCJD-Ophtha Commission“ (vCJK-Ophtha) of the German Society of Ophthalmology (DOG)
and Working Group Instrument Preparation (AKI) in cooperation with the firm Geuder AG
O phthalmologic instruments, in particu-
lar those used for surgery of the poste-
rior segment of the eye should, as advocated
by the Recommendation of the Robert Koch
Institute (RKI) to prevent iatrogenic spread of
transmissible spongiform encephalopathies,
be reprocessed while also using an alkaline
cleaning step. The present study investigated
the effects of automated processes with and
without steam sterilisation on the material
compatibility and functionality of the instru-
ments and also tested for absence of residual
process chemicals. Inspection of the instru-
ments after 100 decontamination cycles in
each case did not show any sign of adverse
effects on material compatibility or function-
ality. There was evidence of a risk of alka-
line residues in narrow-lumened cannulas,
especially if these became blocked during
the decontamination process. Therefore a mi-
crofilter must be installed when purging these
and routine spot checks must be carried out
to check for any residual alkalinity.
Introduction
The RKI Memorandum ”Variant Creutz-
feldt-Jakob Disease“ (1) recommends that
medical devices belonging to Semi-Criti-
cal A and Critical A and B classes be de-
contaminated using an automated process
that includes an alkaline cleaning step,
e.g. using surfactant detergents.
Roth et. al (2) have investigated and
confirmed that automated processes are
possible in principle for ophthalmologic
instruments and to what extent these in-
struments can be cleaned.
In the meantime there have been sev-
eral reports from the field that validated de-
contamination of the instruments used
for intraocular surgery of the anterior seg-
ment of the eye (e. g. for cataract) is pos-
sible using alkaline detergents (Knoche
[3], Roider [4]).
The desire to minimise prion trans-
mission risks as expressed in the recom-
mendation that alkaline detergents be
used is important, in particular for surgery
of the posterior segment of the eye, where
prions can be detected in the retina, op-
tic nerve, vitreous body of the eye and in
the subretinal fluid seen in cases of reti-
nal detachment (5).
Accordingly, instruments coming into
contact with these high-risk tissues are
deemed to act as a potential source of
contamination or of other infections
caused by prions.
An optimal solution would be to re-
sort to the use of ”single-use instruments“
that would be disposed of after use. That
would not be a practical option here in
view of, first, the quality of the materials
used and, second, because of the costs
incurred. Therefore a validated deconta-
mination process that complies with the
provisions of the RKI Recommendation
is needed. But finding such a process is
all the more difficult since the majority of
the instruments used in ophthalmic sur-
gery are assigned to the Critical B and
Critical C subgroups by virtue of their fine
mechanical design, frequent presence of
lumens and, in some cases, of the fact that
they are heat sensitive (6). As such, re-
moval of the contaminants accruing dur-
ing surgery but, equally, reliable elimina-
tion of residues of the chemicals used for
the decontamination process by subse-
quent rinsing is a problem.
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This is particularly true as regards the al-
kaline detergents advocated. If one views
this in the light of the demonstrated re-
duction in the potential prion load, the
ophthalmology surgeon will, nonetheless,
be concerned about deterioration of the
quality of the results achieved for surgery
because of the damage inflicted by the
decontamination process on microinstru-
ments and because of alkaline residues.
The aim of this study, jointly conduct-
ed by researchers comprising the Working
Group Instrument Preparation (AKI), the
firm Geuder AG, a manufacturer of oph-
thalmologic instruments, and the ”vCJD-
Ophtha Committee“ (vCJK-Ophtha) of the
German Society of Ophthalmology (DOG),
was to investigate the instruments typi-
cally used in retinal and vitreous body sur-
gery using various automated decontam-
ination processes with and without sub-
sequent steam sterilisation:
On behalf of the “vCJK-Ophtha” Commission of
German Society of Ophthalmology (DOG):
S. Grisanti, Lübeck; M. Knoche, Stadthagen; K.-D. Lem-
men, Düsseldorf
Working Group Instrument Preparation (AKI):
R. Glasmacher, Düsseldorf; W. Michels, Gütersloh;
J. Staffeldt, Hamburg
Addresses for correspondence:
PD Dr. Klaus D. Lemmen, St. Martinuskrankenhaus,
Völklinger Straße 10, 40129 Düsseldorf, Germany
E-mail: k.lemmen@martinus-duesseldorf.de
Dr. Jürgen Staffeldt, Chemische Fabrik DR. WEIGERT
GmbH & Co. KG, Mühlenhagen 85, 20539 Hamburg,
Germany. E-mail: juergen.staffeldt@drweigert.de
Geuder AG, Frau Pfister, Hertzstraße 4, 69126 Heidel-
berg, Germany. E-mail: MPfister@geuder.de
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Fig. 1: Operating pin, can be sterilised for Fig. 2: Bipolar forceps, straight, 100 mm
MEGATRON equipment system
– Material compatibility and functionality
in respect of alkaline cleaning
– Absence of residues of alkaline deter-
gents
A total of seven different decontamina-
tion processes were used, using both
brand-new as well as, in some cases, al-
ready-used ophthalmologic instruments.
Materials and Methods
Continuous automated tests were con-
ducted at the laboratories of Ecolab GmbH
& Co. OHG, Düsseldorf as well as of
Chemische Fabrik Dr. Weigert GmbH &
Co. KG, Hamburg.
Fig. 4: Lacrimal duct cannula, spherical, stain-
less steel, short-angled
Instruments tested
Both brand-new instruments used in reti-
nal and vitreous surgery from the firm
Geuder AG Heidelberg as well as oph-
thalmic surgery instruments that had al-
ready been used for a long time in various
eye departments were tested. Up to that
date, the used instruments had been re-
processed using standardised manual
methods that did not include the use of al-
kaline detergents.
List of new instruments
The new instruments are shown in fig-
ures 1 to 13. The depicted instruments, as
well as their counterparts that had been
already used for a long time, were inves-
tigated (Figures 14 and 15).
Fig. 5: Injection cannula, bidirectional for liquid
The new and used instruments in-
perfluorocarbons, 24 gauge 0.55 mm vestigated represent the following mate-
side tube: 25 gauge/0.5 mm rials:
CENTRAL SERVICE Volume 17 2009 252
Fig. 3: Diathermy connection cable for the
MEGATRON equipment system
– Plastics: Polyoximethylene (POM), poly-
tetrafluorethylene (PTFE), silicon
– Metals: Nickel-plated brass, titanium,
stainless steel with material numbers
1.4301, 1.4404, 1.4024, 1.4310, 1.4034
und 1.4401, colour-anodised aluminium
Washer-disinfectors and steam sterilisers
The washer-disinfectors (WDs) used at
both Ecolab and Dr. Weigert were a Miele
G 7736 machine with the E 440 load carri-
er for connection to the WD. The cleaning
pressure prevailing at the nozzles on the up-
per level of the load carrier was 125 hPa.
For steam sterilisation the steriliser
MMM Uni Steri 3-3-6 ED was used at
Ecolab and the steriliser MMM Uni Steri
AV F 134 at Dr. Weigert.
Please refer to Figures 16 and 17 to
see the load carrier connections used dur-
ing automated reprocessing. The instru-
ment trays and load carriers used had fa-
cilities for securing delicate instruments as
well as for connecting cannulas and oth-
er lumened instruments such that their
direct irrigation was assured.
Processes investigated
A total of seven different decontamina-
tion processes were investigated in ac-
cordance with Table 1.
For processes 1, 2, 4 and 5, two dif-
ferent alkaline detergents were tested, in
each case with (processes 2 and 5) and
without (processes 1 and 4) alternating
steam sterilisation.
Process 3 entailed only steam sterili-
sation. Processes 6 und 7 were automat-
ed decontamination processes conducted
without detergents both with and with-
Alkaline Detergents for Automated Reprocessing of Ophthalmic Surgery Instruments
Fig. 6: Ophthalmo-microsurgical scissors,
Tübingen model bent, 8 cm
Fig. 8: Vitreous cutting device MEGA-VIT mag-
netic high-speed driver red marking
Fig. 9c: Transport sheath for MEGA-VIT cutting
head
out alternating steam sterilisation. Process-
es 3, 6 and 7 without use of an alkaline de-
tergent were conducted so as to investi-
gate any effects other than those exerted
by alkaline detergents.
Table 2 shows the program sequences
used for automated reprocessing.
For steam sterilisation the prolonged
18-min hold times were used at 134 °C to
simulate worst-case conditions for all loads
as recommended by the RKI for repro-
cessing medical devices without the use
of alkaline detergents. Pursuant to the RKI
Fig. 7a: Vitrectomy forceps 45° angled
20 gauge/0.9 mm with cleaning adapter
and protective cap
Fig. 9a: MEGA-VIT standard cutting head cutting
tube 20 gauge/0.9 mm green marking
Fig. 10: Membrane ”Peeler“ blunt, functional part
20 gauge/0.9 mm
provisions, a 5-min sterilisation time at
134 °C was used otherwise following al-
kaline automated cleaning.
In each case 100 reprocessing cycles
were run using brand-new ophthalmologic
instruments and the seven different
processes outlined above.
The already-used instruments were
reprocessed in each case 50 times in the
two series with alkaline cleaning and sub-
sequent steam sterilisation and with al-
kaline cleaning without subsequent steam
sterilisation (processes 4 and 5).
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Fig. 7b: Vitrectomy forceps, straight, gripping sur-
faces at tips, titanium handle 20 gauge/
0.9 mm (beside it cleaning adapter)
Fig. 9b: Cleaning adapter for MEGA-VIT cutting
head
Fig. 11: Piezoceramic ultrasonic handpiece P2
(phaco handpiece) Diameter 14.5 mm,
length 125 mm
Evaluation
The instruments were evaluated in terms
of material damage or impaired function-
ality by the firm Geuder. To that effect, the
surfaces of the instruments were in-
spected under a microscope using 15- to
20-fold magnification. In addition, func-
tionality, such as patency, cutting and
gripping properties, was assessed. Elec-
trically powered devices such as ultra-
sonic handpieces or electromagnetic vit-
rectomy instruments were inspected for
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Test Automated Alkaline pH value of use concentration Neutralisation Steam sterilisation

cleaning detergent in the machine 134 °C/18min

1 yes Sekumatic FR 11 – 11.5 Sekumatic FNZ no

2 yes Sekumatic FR 11 – 11.5 Sekumatic FNZ yes

3 no yes

4 yes neodisher SeptoClean 11.5 – 11.9 neodisher Z no

5 yes neodisher SeptoClean 11.5 – 11.9 neodisher Z yes

6 yes No detergent none no
Only water
7 yes No detergent none yes
Only water

Table 1: List of decontamination processes used

Program cycle Design

Precleaning Softened cold water; 1 min
Cleaning Cold water inflow (softened), at 40 °C. Dosage of detergent, 5 ml/l, further
heating to 55 °C with subsequent 10-min hold time
Neutralisation Cold water inflow (softened) and dosage of citric acid neutralising
agent, 1 ml/l, 1-min hold time
Intermediate rinse Cold water (softened), 1 min
Final rinse with Demineralised water (water quality as recommended by the Working Group
thermal disinfection Instrument Preparation (AKI) in the brochure ”Proper Instrument Mainte-
nance“ 6, page 17), heating to 93 °C with subsequent 5-min hold time
Drying 20 min

Table 2: Program sequences used for automated reprocessing

Fig. 12: Ultrasonic tip, titanium, 30° connected to
cleaning adapter
Fig. 13: Infusion nozzle with cleaning adapter
functionality, electrical safety and other
typical characteristics, e. g. oscillation be-
haviour.
The instruments were inspected for al-
kaline residues at Ecolab and Dr. Weigert
immediately after the automated decon-
tamination process.
Special attention was paid here to de-
contamination of the ”critical“ longer
lumened devices with an inner diameter
< 0.5 mm such as cannulas. To that effect,
using a compressed air pistol any liquid
residues were purged directly from the
still wet cannulas onto pH paper immedi-
ately after the automated cleaning process.
Results
There was no evidence of material dam-
age or surface alterations on instruments
made of the materials POM, PTFE, sili-
con, nickel-plated brass, titanium, stain-
less steel with material numbers 1.4301,
1.4404, 1.4024, 1.4310, 1.4034 and 1.4401
in any of the seven series of tests.
Only on the colour-anodised aluminium
instruments were discolorations noted,
but these were also seen in the test se-
ries where no detergent was used.
In isolated cases spots were detected
on the reprocessed instruments; these
were imputed to constituents of the ster-
ilisation steam condensate present dur-
ing certain phases and were also seen on
instruments that had been subjected to
steam sterilisation alone.
In none of the seven series of tests
was instrument functionality impaired.
No differences were found between
the results obtained on inspecting brand-
new and already-used instruments.
A check for entrainment of any alka-
line residues with the cannulas showed
in isolated cases alkaline residues of
around pH 10. However, when taking in-

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Alkaline Detergents for Automated Reprocessing of Ophthalmic Surgery Instruments
Fig. 14
to account all test series conducted with
alkaline detergents, these isolated cases
amounted to fewer than 3% of the entire
number of cannulas reprocessed, but the
site at which the instruments were po-
sitioned within the load carrier also played
a role.
However, at the time these tests were
carried out no microfilter had yet been fit-
ted, which today is recommended as stan-
dard practice by the WD manufacturers to
prevent blockage. If cannulas became
blocked during the alkaline cleaning step,
it would not have been possible other-
wise to adequately rinse out the residues
of the alkaline detergents.
Fig. 16
Fig. 15
Discussion of Results
The test results show that the use of al-
kaline detergents to assure reliable re-
processing as advocated by the RKI Mem-
orandum can also be used in principle for
the surgical instruments used for the pos-
terior segment of the eye.
However, the following preconditions
should be met as standard practice:
– suitable load carrier for
앫 secure connection of lumened in-
struments so that they can be reli-
ably irrigated throughout the entire
reprocessing cycle
앫 secure positioning of instruments
so that they do not become dis-
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placed in the washer-disinfector
chamber due to the pressure gen-
erated by the spray jets
– check for residual alkalinity, in particu-
lar for instruments with narrow lumens,
especially cannulas. This is done using
medicinal compressed air to blow out
any liquid residues onto pH paper with
0.5 unit graduations
– demineralised water for the final rinse
step(s) to prevent drying marks and
residues of water constituents as per
the brochure compiled by the Working
Group Instrument Preparation 7.
– water quality for sterilisation as per EN
285.
Below are outlined additionally potential
measures for optimisation of automated
reprocessing; these had not yet been im-
plemented at the time of testing but their
potential benefits were revealed by the
test results and by other experiences from
the field.
To prevent blockage that can occur
during alkaline cleaning and, hence, could
possibly give rise to entrainment of alka-
line residues the following measures are
recommended for very narrow-lumened in-
struments:
– use microfilters
– interpose an additional second rinse
step between neutralisation and the fi-
Fig. 17
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nal rinse to further minimise the risk of
entrainment of alkaline detergent
residues
As regards the discolorations seen on an-
odised aluminium instruments, it must be
borne in mind that these did not adversely
affect instrument functionality. The exis-
tence of such ”cosmetic“ discolorations
has been known for a long time, see the
brochure compiled by the Working Group
Instrument Preparation 6. Hence today
preference is given to instruments made
of resistant metals.
In principle when purchasing/choos-
ing new instruments it is recommended
that
– instruments that are easy to dismantle
be chosen, as they are more amenable
to reprocessing, including to cleaning
– attention be paid to, apart from heat
resistance, the compatibility of materials
and of surfaces with alkaline deter-
gents
”vCJK-Ophtha“ Commission of the DOG, AKI
It is proposed that the instrument manu-
facturers take the following measures to
make their products more amenable to
automated decontamination:
– Ensure that instruments can be easily
dismantled into individual components
– Design wall structures with perfora-
tions, if possible
– Manufacture/deliver cleaning adapters
to facilitate connection to the load car-
riers used in conventional washer-dis-
infectors. ❉ bereitung ophthalmochirurgischer Instrumente. OPH-
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