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765

REVIEW/UPDATE

Guidelines for the cleaning and


sterilization of intraocular surgical
instruments
David F. Chang, MD, Co-chair, Nick Mamalis, MD, Co-chair,
Ophthalmic Instrument Cleaning and Sterilization Task Force

These Guidelines for the Cleaning and Sterilization of Intraocular practices for sequential same-day anterior segment surgery. Other
Surgical Instruments were written by the Ophthalmic Instrument studies substantiate the risk of toxic anterior segment syndrome
Cleaning and Sterilization (OICS) Task Force, comprised of repre- from routine use of enzymatic detergent, whose microscopic resi-
sentatives of the American Society of Cataract and Refractive Sur- dues are difficult to eliminate from intraocular instrumentation.
gery, the American Academy of Ophthalmology, and the Outpatient Finally, based on published international outcomes and endoph-
Ophthalmic Surgery Society. These consensus subspecialty guide- thalmitis rates, future studies should critically evaluate a variety of
lines include evidence-based recommendations regarding issues operating room protocols that may increase cost, waste, and car-
that may be unique to the cleaning and sterilization of intraocular bon footprint, without any actual safety benefit.
instrumentation. A newly published OICS Task Force study sup-
ports the safety of common short-cycle instrument processing J Cataract Refract Surg 2018; 44:765–773 Q 2018 ASCRS and ESCRS

P
ostoperative infectious endophthalmitis and toxic Most of the recommended practices are derived from ex-
anterior segment syndrome (TASS) are rare, but isting evidence-based recommendations for cleaning and
potentially sight-threatening, complications of cata- sterilizing all surgical instruments in general,2–4 from pub-
ract and other intraocular surgery. The small volume of lished analyses of TASS outbreaks,5–12 and from manufac-
the eye and its sensitivity to minute amounts of chemical turers’ instructions for use (IFU) for surgical instruments
or microbial contaminants means that improper instru- and equipment. In addition, task force members have
ment cleaning or sterilization practices might pose a sig- collaborated in performing new research that supports
nificant risk to patients. The Ophthalmic Instrument certain recommendations, which is referenced in this
Cleaning and Sterilization (OICS) Task Force is made document.
up of representatives of the American Society of Cataract This specialty-specific document seeks to outline min-
and Refractive Surgery (ASCRS), the American Academy imum standards for intraocular instrument cleaning and
of Ophthalmology (AAO), and the Outpatient sterilization based on a consensus of experts represent-
Ophthalmic Surgery Society (OOSS). These professional ing the 3 sponsoring societies. Although developed spe-
societies represent ophthalmologists and the clinical staff cifically for cataract surgery, the recommendations in
of ophthalmic outpatient surgery centers, including sur- this document are also relevant for instruments used in
geons, nurses, and technicians. The OICS Task Force in- other intraocular surgical procedures. It is not intended
cludes experts on TASS and endophthalmitis and has to be a comprehensive list of every requirement for ster-
written this document to provide specialty-specific, evi- ilization and quality assurance of the sterilization pro-
dence-based guidelines for the cleaning and sterilization cess. Individual centers might elect to incorporate
of intraocular surgical instruments. This document is an additional measures beyond what is outlined in this
update of original recommended practices for cleaning document.
and sterilizing intraocular surgical instruments published Appropriate consideration should also be given
in 2007.1 to guidelines from other relevant organizations.2–4,13

From the Altos Eye Physicians (Chang), Los Altos, California, and the John A. Moran Eye Center (Mamalis), University of Utah, Salt Lake City, Utah, USA.
A full list of the Ophthalmic Instrument Cleaning and Sterilization Task Force members appears at the end of this article.
Corresponding author: David F. Chang, MD, 762 Altos Oaks Drive, Los Altos, California 94024, USA. Email: dceye@earthlink.net.

Q 2018 ASCRS and ESCRS 0886-3350/$ - see frontmatter


Published by Elsevier Inc. https://doi.org/10.1016/j.jcrs.2018.05.001
766 REVIEW/UPDATE: GUIDELINES FOR THE CLEANING AND STERILIZATION OF INTRAOCULAR SURGICAL INSTRUMENTS

However, many recommendations from these published models included 100% physician owned, corporate affili-
guidelines are made with respect to all surgical procedures ated, hospital affiliated, and hospital outpatient depart-
and are not specific to ophthalmic instrumentation and ments (HOPD). For the purposes of analyzing cleaning
surgery. Therefore, those recommendations often do not and sterilization practices for ophthalmic surgery specif-
take into account the unique conditions of intraocular sur- ically, multispecialty ASCs, hospital-affiliated ASCs and
gery and special requirements for cleaning and sterilizing HOPDs were excluded. In total, 182 complete responses
ophthalmic instrumentation. As a result, all-inclusive, were analyzed for this OICS guideline document. During
broad guidelines attempting to cover surgery from head the preceding 12 months, the responding single-specialty
to toe could sometimes include inappropriate, or even ris- ASCs reported performing a total of 608 117 eye surgical
ky, practices for ophthalmic cases. For example, cataract procedures. The overall infection rate was 0.02%, with
surgeries are shorter than many general surgical proce- 116 facilities reporting zero cases and 66 facilities reporting
dures and are often performed with higher daily volumes. 104 cases of endophthalmitis. The overall rate of TASS was
Intraocular surgical instruments are among the smallest in 0.01%, with 161 facilities reporting zero cases and 21 facil-
size and generally do not become heavily soiled from tissue ities reporting a total of 50 cases. Most facilities (97.3%) had
or bacterial contamination. On the other hand, minute been inspected by a regulatory agency during the previous
amounts of detergent or chemical contaminants that 3-year period. As a result of the inspection, 16.9% of the fa-
would be well tolerated in other body cavities can cause se- cilities reported being asked to change cleaning or steriliza-
vere intraocular inflammation (TASS) when introduced tion protocols.
into the eye.14,15 These characteristics might differentiate
optimum cleaning and sterilization procedures for cataract GENERAL ADMINISTRATIVE PRINCIPLES
surgery from those required for many other types of All facilities should establish written protocols for instru-
surgery. ment cleaning and sterilization. These “policies and proce-
dures” should be based on industry standards and guidelines
TOXIC ANTERIOR SEGMENT SYNDROME with input from the nursing and medical staff. They should
Toxic anterior segment syndrome is an acute severe inflam- be approved by the governing body of the facility and be
matory reaction to a toxic contaminant introduced into the available to operating room (OR) and instrument process-
anterior chamber during intraocular surgery. In addition to ing staff. In addition, these policies and procedures should
severe anterior chamber cell and flare, it might be associated be reviewed annually and on acquisition of new instrumen-
with fibrin, hypopyon, diffuse limbus-to-limbus corneal tation or sterilizing equipment.2,3 We acknowledge the wide
edema, atonic pupil, secondary glaucoma, and in some diversity among ophthalmic surgical settings and in the sur-
cases, vitreous cells.16 Because of these signs, TASS might gical products and instrumentation used. Physician and
be misdiagnosed and mistreated as infectious endophthal- nursing medical staff directors should be allowed some
mitis. Even if TASS resolves with treatment and without discretion in developing and reviewing their facility’s writ-
permanent sequelae, the patient often suffers the emotional ten policies and procedures for instrument cleaning and
trauma of believing he or she might have a potentially sterilization based on the best available clinical evidence.
blinding infection. These should then be approved by the facility governing
A large outbreak of TASS in 2006 led to the formation of body.
the ASCRS TASS Task Force, whose surveys and site visits Personnel involved should be properly trained in
have consistently shown that improper instrument cleaning handling, cleaning, and sterilizing intraocular surgical in-
and sterilization is the most commonly identified cause of struments and subject to periodic oversight.2,3,13 In addi-
TASS.17,18 The TASS Task Force separately analyzed and tion to the general principles of asepsis, this training
compared causes of TASS during 2 periods: 2007–2009 should also include the cleaning, inspection, preparation,
and 2009–2012.17,18 Data from 130 questionnaires and 71 packaging, sterilization, storage, and distribution of intra-
site visits to affected ambulatory surgery centers (ASCs) ocular surgical instruments. Appropriate staff should also
were incorporated into the final analysis of 1454 cases of be trained in related tasks, such as equipment operation
TASS from approximately 69 000 concomitant cataract sur- and preventive maintenance. They should undergo compe-
geries. The most common risk factors for TASS included tency validations by direct observation of performance.2,3
inadequate flushing and rinsing of handpieces, use of Staff education, training, and the validation of competency
enzyme detergents, and use of ultrasonic baths.18 should be updated and documented at least annually and
coincident with introduction of new surgical equipment,
2014 OPHTHALMIC AMBULATORY SURGERY medical devices, or packaging systems.2,3
CENTERS SURVEY OF STERILIZATION PRACTICE Both infectious endophthalmitis and TASS are rare
In 2014, a survey developed by the OICS Task Force was events, and their incidence should be monitored as a means
sent to OOSS member–ASCs regarding cleaning and steril- of confirming the safety and efficacy of the facility’s written
ization of intraocular instruments. The survey was protocols. The OR staff should be educated about the causes
completed by 232 respondent centers representing a variety of both endophthalmitis and TASS. A surveillance system
of ambulatory surgical settings including single-specialty for reporting and documenting infectious endophthalmitis
ophthalmology and multispecialty centers. Ownership and TASS should be implemented. Any increase in the

Volume 44 Issue 6 June 2018


REVIEW/UPDATE: GUIDELINES FOR THE CLEANING AND STERILIZATION OF INTRAOCULAR SURGICAL INSTRUMENTS 767

frequency of infectious endophthalmitis or TASS should and over instruments, with effluent discarded so that only
prompt a thorough analysis and documented review of debris-free water is used for subsequent rinsing.
the facility’s procedures and protocols for instrument clean-
ing and sterilization.17 Records of instrument use, of medi- ENZYMATIC DETERGENT
cation use, and of sterilization procedures should be One practice that is controversial is the use of enzymatic de-
maintained in accordance with facility policy.2–4,16 Such re- tergents for decontaminating intraocular surgical instru-
cords might aid in the investigation of any outbreaks of ments. The manufacturer’s IFU that accompany
TASS or infectious endophthalmitis.2–4,16 ophthalmic instruments and ultrasound cleaning baths
often call for the use of enzymatic cleaners, the omission
of which would therefore be considered off-label. However,
CLEANING INTRAOCULAR SURGICAL the necessity of enzymatic detergents for cleaning contam-
INSTRUMENTS inated intraocular instruments has not been established.
Cleaning and decontamination, which include thorough Contrary to some manufacturers’ IFU for their intraocular
rinsing and flushing, should precede disinfection or sterili- instrument, it is our position that enzymatic detergents
zation. It is recommended that ophthalmic instrumentation should not be routinely required for intraocular instru-
should be cleaned separately from nonophthalmic surgical ments for several reasons. These detergents typically
instruments. Contaminated and soiled instruments should contain subtilisin or alpha amylase exotoxins, neither of
also be cleaned in an area separate from where packaging which is denatured by autoclave sterilization. Corneal
and sterilization take place. endothelial toxicity from enzymatic detergents has been
During decontamination and cleaning, all debris inclu- documented in both animal and human studies.15,26,27
sive of ophthalmic viscosurgical device (OVD) should be Inappropriate use or incomplete rinsing of enzymatic deter-
removed from the instruments.7,16,19 It might be helpful gents has been associated with outbreaks of TASS.17,18
to keep instruments moist until the cleaning process begins The purpose of enzymatic detergent is to assist in the
to avoid drying of debris and OVD.2,3,16,20 A dampened removal of bulk biomaterial from surgical instruments.
lint-free cloth or soft brush should be used to clean instru- However, intraocular instruments acquire minimal bio-
ments in accordance with the manufacturer’s IFU.3,4 Addi- burden during eye surgery and the material they do collect
tional or repeated cleaning and rinsing steps might be is usually completely removed with prompt manual rinsing
required on an instrument-by-instrument basis to ensure and cleaning. Studies have shown that while following the
removal of all debris and OVD.21 manufacturer’s IFU, even minute enzyme residue left on
The volume and type of water for cleaning and rinsing in- intraocular instruments can cause TASS.14 The small-
struments should follow the manufacturer’s IFU.2,3,22 The diameter lumens and fragile nature of intraocular instru-
IFU for many intraocular instruments recommend or ments often make complete removal of all traces of enzyme
require critical water (sterile distilled, reverse osmosis, or detergent difficult. A recent study from the Moran Eye Cen-
deionized) for most cleaning steps and for final rinsing.16,23 ter found that detergent residues can be detected by scan-
Flushing instruments with lumens should be initiated in the ning electron microscopy (SEM) and energy dispersive
OR and completed in the decontamination area.3,4 When x-ray spectroscopy (EDS) on the surface of phaco tips even
sterile water baths are used for cleaning or soaking soiled after meticulous rinsing with sterile water prior to steriliza-
instruments in the OR, they should be separated from the tion following the instrument manufacturer’s IFU.28 Much
sterile field and instruments still in use. When flushing is larger enzyme residues are found if thorough rinsing is not
used as part of a cleaning technique, the effluent should performed.28
be discharged into a sink or separate basin while mini- Rabbit studies performed at the Moran Eye Center
mizing splash and aerosolization so that contaminated fluid analyzed whether enzymatic detergents used to clean
is not spread. ophthalmic instruments can cause TASS-like responses.14
Facilities might consider discarding cleaning syringes or Different dilutions of enzymatic detergent were injected
brushes after each use. If brushes are reused, they should into the anterior chambers of rabbit eyes, and the animals
be cleaned and disinfected or sterilized at least once were evaluated postoperatively for signs of anterior segment
daily.4,24 Instruments should be visually inspected for inflammation. Severe anterior segment inflammation,
debris and damage after cleaning and before packaging including fibrin formation, developed within 72 hours after
for sterilization to ensure removal of debris.4,13,16,25 the injections. There was a dose-related correlation between
Immediately after use, phacoemulsification and irriga- the enzyme concentration and the severity of the inflamma-
tion/aspiration (I/A) handpieces can be placed in a sterile tory response. Post-mortem vital staining showed dose-
water bath that is separated from the active operative field related toxicity from the enzymatic detergent to the corneal
to avoid drying of the OVD until cleaning.2,3 Instruments endothelium.
with lumens, such as phaco or I/A handpieces, should be Many ASCs specifically avoid using enzymatic detergent
cleaned and flushed in accordance with the manufacturer’s for intraocular instruments that, depending on the instru-
IFU. All debris including OVD should be removed ment, might be an off-label practice. In the 2014 survey
promptly.2,3 Many IFU specify thorough flushing with crit- of OOSS member ASCs, the majority of facilities (55.5%)
ical water. Rinsing should provide flow of water through did not use an enzymatic cleaner for intraocular instrument

Volume 44 Issue 6 June 2018


768 REVIEW/UPDATE: GUIDELINES FOR THE CLEANING AND STERILIZATION OF INTRAOCULAR SURGICAL INSTRUMENTS

decontamination compared with 44.5% who did. The registered, facility-approved disinfectant and followed by
average self-reported rate of endophthalmitis was 0.021% critical water rinsing sufficient to fully remove the cleaning
for non-enzyme-using facilities compared with 0.027% for agent. If not contraindicated by the ultrasonic cleaner’s
enzyme-using facilities. We are not aware of any study IFU, a final rinse with 70% to 90% ethyl or isopropyl alcohol
showing that enzyme detergent for intraocular instruments should be considered for the ultrasound cleaning compart-
reduces the rate of endophthalmitis. Lacking proven effi- ment. The machine should be dried completely with a lint-
cacy for endophthalmitis prevention, enzymatic detergents free cloth and then cleaned following the manufacturer’s di-
might unnecessarily elevate the risk for TASS without rections before the next use.24,30
providing significant benefit to the patient. It is our position
that if intraocular surgical instruments are thoroughly REUSE OF PHACO TIPS
rinsed with critical water promptly after each use, the When feasible and safe, reuse of some surgical instruments
routine use of enzyme detergents is unnecessary and should might improve the cost-effectiveness of cataract surgery. In
not be required for routine decontamination of ophthalmic addition to proper cleaning and sterilization to prevent mi-
intraocular instruments. crobial contamination, appropriate reuse requires preser-
Some instrument IFU, however, specify use of enzymatic ving the structural integrity of the instrument so that it
detergent, and this has led to surgical centers that are not maintains its surgical function. In many international set-
using enzymatic detergent to be cited by surveyors for the tings, phaco tips are routinely reused to reduce waste and
Centers for Medicare and Medicaid Services (CMS) or the cost of replacement. At the surgeon’s discretion, a
other regulatory agencies. After meeting with CMS, the used tip can be discarded if any reduced cutting efficiency
U.S. Food and Drug Administration (FDA), and the Asso- is noted. We are unaware of convincing evidence to suggest
ciation for the Advancement of Medical Instrumentation that this potentially off-label practice is dangerous or less
(AAMI) about the potential risk for TASS from this prac- effective than using a new phaco tip for every case.
tice, our OICS Task Force issued an appeal to intraocular Although most phaco tips are made of a comparable tita-
surgical instrument manufacturers in 2016 to validate alter- nium alloy,31 there is wide disparity in the labeling for reuse
nate cleaning and decontamination methods that do not between manufacturers. One manufacturer (Alcon, Fort
require the routine use of enzymatic detergent. Worth, TX) specifies single use only for all its phaco tips.
Enzymatic detergent cleaning may be warranted in Another manufacturer (MicroSurgical Technology, Red-
certain situations. If enzyme detergents are used for any mond, WA) allows 50 reuses of its phaco tips. A third
reason, instructions for proper dilution and disposal of manufacturer (Abbott Medical Optics/Johnson & Johnson
cleaning solutions should be followed. The cleaning solu- Vision, Santa Ana, CA) allows 20 reuses of 1 tip yet only
tion should be mixed with measured amounts of water a single use for its other model of phaco tip.
and detergent (ie, not mixed with estimated volumes) ac- One study performed at the Moran Eye Center assessed 8
cording to the detergent’s IFU.3,4,22 The instruments should phaco tips (both single use and reusable) after 10 autoclave
be thoroughly rinsed to ensure removal of all cleaning sterilization cycles.28 None of the tested tips showed any
agents as well as all debris loosened during the cleaning pro- significant morphologic changes on SEM or EDS analysis.
cess.15,16,20 Use of tap water for rinsing and for removal of A second Moran Eye Center study in conjunction with
detergent should be used only if in compliance with the the Utah Nanofab Laboratory tested 8 phaco tip models
manufacturer’s IFU for the detergent and for the equip- from 3 manufacturers using a well-described ex vivo
ment. Because tap water can contain heat-stable endotoxin porcine cataract model. SEM and white-light interferom-
from gram-negative bacteria found in the municipal water etry (WLI) testing of each tip was performed after 5 simu-
supply, critical water is recommended for the final instru- lated reuses involving prolonged continuous ultrasound
ment rinse.16,23 cycles in nuclei of varying density.32 Regardless of whether
they were labeled for single or multiple use, the reused pha-
ULTRASONIC CLEANING co tips in this experimental model did not show significant
Ultrasonic cleaning poses another risk factor for TASS ac- ultrastructural damage or wear, such as microfracture,
cording to the TASS Task Force surveys. If an ultrasonic deformation, fissures, or breakage. This model was very
cleaner is used, the technician should remove all visible robust, using the maximum 100% continuous longitudinal
soil before placing instruments in the ultrasonic cleaner. phaco power setting that would be equivalent to 10 minutes
The ultrasonic unit should be designated for cleaning med- of continuous phaco at 20% power. Not surprisingly, some
ical instruments and preferably should only be used for superficial surface changes on used tips were found on SEM
ophthalmic instruments. If a unit is used for other types in this study and a second study evaluating clinically used
of surgical instruments, it should be emptied, cleaned, tips.33 The theoretical significance or relevance of these
and rinsed before use with ophthalmic instruments to avoid microscopic surface changes is debatable, but they should
cross contamination.4 not pose a safety risk. The results in these studies suggest
Ultrasonic machines should be emptied, cleaned, disin- that labeling some titanium phaco tips for single use might
fected, rinsed, and dried at least daily.9,10,29 Unless other- be arbitrary, in particular when virtually identical titanium
wise specified by the manufacturer, cleaning should be tips are labeled for 20 or 50 uses by different manufacturers.
performed with an Environmental Protection Agency- Lacking clinical evidence to the contrary, we suggest that

Volume 44 Issue 6 June 2018


REVIEW/UPDATE: GUIDELINES FOR THE CLEANING AND STERILIZATION OF INTRAOCULAR SURGICAL INSTRUMENTS 769

manufacturers perform validation studies for reusable pha- sterilization that is acceptable for routine use for a wrap-
co tips. With respect to the tips tested in this study, we ped/contained load where pre-cleaning of instruments is
concur with the investigators’ suggestion that cataract sur- performed according to the manufacturers’ instructions,
geons be allowed discretion in terms of reusing phaco tips and the load meets the device manufacturer’s instructions
off-label based on their clinical observations and for use (IFU), includes use of a complete dry time and is
judgment.32,34 packaged in a wrap or rigid sterilization container validated
for later use. Use of short-cycle sterilization is particularly
STERILIZATION OF INTRAOCULAR SURGICAL common in facilities that perform eye surgery and is accept-
INSTRUMENTS able when all IFU (ie, sterilizer, device, and container man-
Sterilization process monitoring and management are crit- ufacturer’s) are followed. However, there appears to be
ical to the ASC infection control program. Adequate time to confusion in the field about the differences between IUSS
follow recommended procedures for cleaning and steriliza- and short cycle sterilization, and misuse of the term IUSS
tion of instrumentation should be established.13,35 The to refer to what is in fact short cycle sterilization. Facilities
method of instrument sterilization should be based on performing surgery should understand the differences be-
guidelines from the medical device, packaging system, tween IUSS and short cycle sterilization in order to ensure
and sterilizer manufacturer. Routine monitoring and verifi- that they comply with Medicare infection prevention and
cation of sterilizer function with biological indicators control requirements”.38
should be performed at least weekly, and preferably daily,
in accordance with the sterilizer manufacturer’s IFU and SHORT-CYCLE, SEQUENTIAL, SAME-DAY USE
documented in the facility log.2–4 Measures should be taken The importance of complete drying of ophthalmic surgical
to ensure that preventive maintenance, cleaning, and in- instruments after steam sterilization depends on how the
spection of sterilizers are performed and documented on load is handled and stored on completion of the steriliza-
a scheduled basis, according to the sterilizer manufacturer’s tion cycle. Moisture present after sterilization could provide
IFU.2–4 a vector for microorganisms from the environment or non-
Strict adherence to every IFU might not always be sterile hands to enter a closed packaging system and
possible. There might be discrepancies between the individ- contaminate the contents of the load. Therefore, unless
ual IFU for the sterilizer, packaging system, and/or medical otherwise specified by a packaging system’s IFU, wrapped
device. Many surgical trays have instruments from more instruments being terminally sterilized before overnight
than one manufacturer, which could have conflicting IFU. storage should always be completely dry. This is also neces-
Separating instruments by manufacturer and performing sary to ensure integrity of the microbial barrier of any in-
different sterilizing procedures for each instrument group strument packaging system or wrapping that will be
is not practical. In these situations, it is appropriate for phy- handled by nonsterile hands.
sicians and nurses to exercise their best clinical judgment in Short-cycle sterilization for a contained wrapped or un-
establishing instrument cleaning and sterilization policies wrapped load is appropriate for sequential same-day instru-
that maintain safety while resolving conflicting IFU. ment reuse. Unwrapped sterile instruments should be
Complete terminal, wrapped sterilization cycles should protected from microbial contamination during transfer
be used to sterilize ophthalmic surgical instruments that from the point of sterilization to the point of use. This
will be stored overnight for future use. Short-cycle steam might be accomplished with an approved covered contain-
sterilization is commonly used for what we refer to as ment device. Some sterilizer IFU permit interruption of the
sequential same-day ophthalmic procedures; that is, subse- drying phase under certain circumstances.39 The risk for
quent consecutive surgeries occurring on the same day the infection resulting from sterile moisture in the container
instruments are sterilized.36 However, the terminology used or on the instruments when the undried (wet) and unwrap-
by agencies that license and regulate ASCs to describe and ped instruments are sterilized for sequential same-day use
differentiate short cycles of steam sterilization has created and are brought from the sterilizer directly to the operating
some confusion among the ophthalmic ASC industry. room in a covered containment device has not been
The CMS Survey and Certification S&C:14-44-Hospital/ established.
CAH/ASC “Change in Terminology and Update of Survey In the 2014 survey of OOSS member ASCs, short-cycle
and Certification (S&C) Memorandum 09-55 Regarding sterilization was commonly used between sequential
Immediate Use Steam Sterilization (IUSS) in Surgical Set- same-day cases (52.3% of respondents). The most
tings” was released in August 2014.37 This defined IUSS commonly used sterilizers for sequential same-day cases
as replacement terminology for the outdated term flash ster- were the AMSCO (STERIS, Mentor, OH) (42.1%) and the
ilization and stated that IUSS was not acceptable as a STATIM (SciCan, Canonsburg, PA) (28.4%). Overall,
routine method of sterilization. IUSS might be used on an 49.7% of responding facilities had a STERIS AMSCO brand
emergent basis to provide instruments to the OR for a sur- sterilizer and 44.3% had a SciCan STATIM brand sterilizer.
gical case that is already underway. After meetings and dis- The following processing methods for instrument steriliza-
cussions with the OICS Task Force, CMS subsequently tion between sequential same-day cases were commonly
clarified in 2015 that “IUSS is not the same thing as used: STATIM cassette (28.2%), closed sterilization con-
“short-cycle” sterilization, which is a form of terminal tainers (26.0%), and wrapped (18.2%).

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770 REVIEW/UPDATE: GUIDELINES FOR THE CLEANING AND STERILIZATION OF INTRAOCULAR SURGICAL INSTRUMENTS

An OICS Task Force-initiated study funded by OOSS, and remain wet as they sit on the sterile instrument table.
ASCRS, and AAO evaluated current practices for Therefore, the theoretical risk from residual moisture
ophthalmic instrument sterilization using the short cycles would primarily be in recontamination of a sterile load
of 2 FDA-cleared steam sterilizers that are in common that was being handled, stored, or transported outside the
use according to the OOSS ASC survey.36 The first was a operating room. Although proximity of the sterilizer to
STATIM 2000 sterilizer (SciCan) using the metal cassette the operating room is preferred for unwrapped sterilization,
provided with the STATIM and the second was an AMSCO the OICS Task Force study showed that moisture in the
Century V116 pre-vacuum sterilizer (STERIS) using a Case covered containment device did not result in recontamina-
Medical SteriTite rigid container (Case Medical, South tion for at least 3 minutes. It is our position that complete
Hackensack, NJ). The evaluations were performed by an in- drying is not necessary to maintain the sterility of wrapped
dependent medical device validation testing laboratory or unwrapped ophthalmic instruments that are kept in the
(Highpower Validation Testing and Lab Services, Roches- covered containment device until retrieved by sterile gloved
ter, NY) and compared wrapped, contained, and unwrap- and gowned staff within the OR for the subsequent case af-
ped instruments with and without interruption of the ter some short delay.
drying phase. Separate studies were performed to verify Low-temperature methods of sterilization should not be
the sterilization efficacy of the 2 sterilizers with short cycles used unless the ophthalmic instrument manufacturer and
as well as the sterility of any moisture present within the 2 the sterilizer manufacturer have validated the method for
instrument-containment devices. Phaco tips and hand- the specific instruments with respect to efficacy of steriliza-
pieces were chosen for evaluation because they represent the tion, potential ocular toxicity (eg, from oxidation of metals),
most difficult items on a cataract tray to clean and sterilize. and instrument functionality.11 Glutaraldehyde is not rec-
Phaco handpieces from each of the 3 major phaco machine ommended for sterilizing laser contact lenses or intraocular
manufacturers in the United Statesdthe Infiniti (Alcon), instruments because of the toxicity of glutaraldehyde resi-
the Signature (Abbott Medical Optics/Johnson & Johnson dues resulting from inadequate rinsing or contamination
Vision), and the Stellaris (Bausch & Lomb)dwere tested. during post-sterilization handling.
Terminal sterilization was performed on each model of
phaco handpiece for overnight storage, and sterilization ef- CARBON FOOTPRINT OF CATARACT SURGERY
ficacy was successfully verified for the STATIM and AMS- Climate change, or global warming, is a serious public
CO sterilizers. These were wrapped (STATIM) or health concern, and the health care industry is a major
contained (AMSCO) loads that were completely dried source of emissions, responsible for 10% of the total carbon
and stored for 7 days before sterility testing. Short-cycle footprint in the United States.34,40–44 Phacoemulsification
sterilization of each handpiece model using unwrapped in the United Kingdom emits approximately 180 kg of car-
(STATIM) or contained (AMSCO) loads was also verified bon dioxide equivalents (CO2-e) per surgery, similar to the
when the drying phase was interrupted after 1 minute. emissions from driving an average U.S. car for approxi-
This simulated prompt use of sterilized instruments that mately 430 miles. Over one half of this carbon footprint
were still wet for a sequential case on the same day. Finally, originates from the procurement of largely single-use sup-
a separate series of studies tested the phaco handpieces and plies. Emissions from phacoemulsification in a high-
containers for moisture sterility after a 3-minute storage/ volume Indian facility are less than 1/10 that in the U.K.
transit period following short-cycle unwrapped or con- with comparable safety outcomes. This is in large part
tained sterilization with interruption of the drying phase af- because of their extensive reuse of surgical materials and in-
ter 1 minute. A storage/transit time of 3 minutes was used struments and their strict surgical and sterilization
to approximate the upper limit of time needed to transfer a processes.43,44
containment device to a nonadjacent operating room. Ster- Most eye surgery centers can reduce their environmental
ility was verified for each handpiece model and contain- emissions by minimizing material use, reusing or reprocess-
ment device. ing surgical materials when applicable, engaging their sup-
Based on these study results and data from the sterilizer ply chain in environmentally preferred purchasing,
manufacturers themselves, it is our position that unwrap- working with facilities management to reduce energy con-
ped settings and short-cycle sterilization used in accordance sumption, safely increasing efficiency of OR turnover, and
with the IFU of FDA-approved sterilizers are appropriate optimizing surgical and central sterile processes. Physician
for routine use in between sequential same-day ophthalmic preference cards for surgical trays and disposable custom
cases.36 Moist or unwrapped instruments sterilized for packs should be reevaluated regularly. For reusable instru-
sequential same-day use should be promptly transported mentation, the environmental footprint can be reduced by
from the sterilizer to the operating room within a covered removing repeated or unnecessary steps in the cleaning and
containment device to prevent microbial recontamination. sterilization process, sourcing energy-efficient appliances,
The covered instrument-containment device should only properly cleaning and maintaining machines, and
be opened in the operating room. If wet, sterile wrapped removing unnecessary instrumentation from surgical trays.
or unwrapped instruments should only be handled by ster- Consideration should be given to using rigid sterilization
ile gloved and gowned staff in a sterile field. Phaco hand- containers or working with waste management to find a re-
pieces are immediately primed with a balanced salt solution cycling option for blue instrument pack wrapping. For

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REVIEW/UPDATE: GUIDELINES FOR THE CLEANING AND STERILIZATION OF INTRAOCULAR SURGICAL INSTRUMENTS 771

more information on reducing environmental emissions, performed to evaluate some practices, such as the reuse of
visit the websites of Practice GreenHealthA or Healthcare disposable instruments. In addition, given the current and
Without Harm.B historically low rates of post-cataract endophthalmitis, costly
new regulations should not be imposed without evidence of
COST-EFFECTIVENESS OF CATARACT SURGERY benefit.45
Cataract surgery is the single most common surgical pro-
DISCLAIMER
cedure in medicine today. The volume and need for cataract
These guidelines are intended to assist ASCs in their efforts
surgery are projected to significantly increase over the next
to adopt appropriate practices for the cleaning and steriliza-
20 years. We quote and agree with this summary from the
tion of intraocular surgical instruments. They are provided
Cataract in the Adult Eye Preferred Practice Pattern pub-
for scientific, educational, and informational purposes only.
lished in 2016 by AAO45:
They are not intended to establish the only acceptable or
“With large projected increases in the elderly population
appropriate standards, methods, or practices for cleaning
worldwide, the significant cost burden of cataract surgery
and sterilizing such instruments. Adherence to these guide-
will continue to increase for every global healthcare system.
lines does not guarantee compliance with any legal or reg-
Because of the societal imperative that cataract surgery be
ulatory standards, including without limitation the criteria
both safe and cost-effective, it is important to evaluate un-
for ASC licensure or certification, or Medicare or other
proven and potentially unnecessary practices based on
third-party payer reimbursement. In addition, any discus-
carefully monitored studies of surgical outcomes.
sion or recommendation in these guidelines regarding the
In many countries, sterilization and aseptic protocols for
use of drugs or devices that deviate from the FDA–
ophthalmic surgery have been arbitrarily defined by na-
approved use of such products (ie, an “off-label use”) is
tional regulatory agencies. Many of these measures origi-
made for scientific and educational purposes only and in-
nated from studies in non-ophthalmic specialties and
tended to fall within the FDA’s “practice of medicine”
may not be specifically validated for ophthalmic surgery,
exception for off-label uses. Individual physicians must
where the source of most infections is the patient’s own
make independent judgments as to whether the off-label
eyelid and external ocular flora. For example, using infec-
use of a particular drug or device is appropriate and in
tion control protocols based on continuous monitoring of
the patient’s best interest based on the facts and circum-
outcomes data, one eye hospital in India reported an en-
stances of the particular case.
dophthalmitis rate of only 0.09% (0.02% of phaco cases)
in more than 42,000 consecutive cataract surgeries using
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REVIEW/UPDATE: GUIDELINES FOR THE CLEANING AND STERILIZATION OF INTRAOCULAR SURGICAL INSTRUMENTS 773

Disclosures: None of the authors has a financial or proprietary in- Relations, Joyce J. D’Andrea, COMT, Director of Allied Health
terest in any material or method mentioned. Education

American Academy of Ophthalmology: Michael X. Repka, MD,


OICS Task Force Members MBA, Flora Lum, MD, Vice President, Quality and Science Division
American Society of Cataract and Refractive Surgery: Robert J.
Cionni, MD, Richard S. Hoffman, MD, Francis S. Mah, MD, Neal H. Ophthalmic Outpatient Surgery Society: Jeffrey Whitman, MD, Michael
Shorstein, MD, Nancey K. McCann, Director of Government A. Romansky, JD, Washington Counsel, Nikki Hurley, RN, MBA, COE

Volume 44 Issue 6 June 2018

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