Sterilization of Ophthalmic Surgical Instruments and Equipment

BSM Connection™
Distance Learning Course
Sterilization of Ophthalmic
Surgical Instruments
and Equipment
© 2011, BSM Consulting

All Rights Reserved.

Sterilization of Ophthalmic Surgical Instruments and Equipment
Table of Contents
OVERVIEW ................................................................................................................................... 1
THE IMPORTANCE OF STERILIZATION AND STERILE TECHNIQUE .................................... 1
THE SPALDING CLASSIFICATION SYSTEM FOR STERILIZATION........................................ 2
CLEANING ................................................................................................................................... 3
INSTRUMENTS USED IN OPHTHALMIC SURGERY ................................................................. 6
STERILIZATION ........................................................................................................................... 9
METHODS OF STERILIZATION IN OPHTHALMIC SURGERY................................................ 10
PRINCIPLES AND RECOMMENDATIONS ............................................................................... 14
CONCLUSION ............................................................................................................................ 16
SOURCES .................................................................................................................................. 17
EXHIBIT 1: TABLE OF COMMON INSTRUMENTS .................................................................. 19
COURSE EXAMINATION .......................................................................................................... 24
© 2011, BSM Consulting

OVERVIEW
In the medical setting, compliance with standards for creating and maintaining an aseptic environment is
an essential responsibility for staff delivering patient care. Both in the office and in the ambulatory surgery
center, basic principles of decontaminating instruments and equipment are essential. Proper technique
when processing sterile ocular instruments is necessary to ensure a satisfactory patient outcome.
Shortcuts are unacceptable, and adherence to established protocol is necessary. This course provides an
overview and then an in-depth listing of these essential steps to ensure a safe environment for the
patient.
The focus of this course will be on the instrumentation used for surgical procedures. Much of the
information in this course also applies to the ophthalmic ambulatory surgery center (ASC). The
information is applicable to the sterile field and the care, decontamination, and sterilization of instruments
when minor surgery is performed in the office. With regard to the sterile field, when there is any doubt, it is
always best to presume that sterility is or has been compromised and then handle the situation
accordingly to ensure patient safety and to mitigate risk of spreading infectious organisms. This course
does not cover establishing a sterile field but presumes that a sterile field is present, and that staff is
wearing appropriate attire.
This course will review the following:
1. Cleaning and decontamination of instruments.
2. Equipment and instruments for eye surgery.
3. Principles of cleaning and sterilizing intraocular surgical instruments.
4. Methods of sterilization for ophthalmic surgical instruments.
5. Recommendations for cleaning and sterilizing intraocular surgical instruments.
6. Basic techniques for ensuring sterile equipment in the operating room.
THE IMPORTANCE OF STERILIZATION AND STERILE TECHNIQUE

Staff members working in the medical clinic setting have an obligation to ensure patient safety. In the
ASC specifically, the Centers for Medicare and Medicaid Services (CMS) require that all ASCs meet
specific infection control requirements. In addition, many ophthalmic ASCs are subject to a survey or
inspection by their accrediting bodies. Regardless of whether accreditation is desired or required, it is the
obligation of the doctors and staff to protect patients and workers. Health care workers must ensure
compliance with infection prevention and control while following established requirements and guidelines,
as well as government regulations.
Maintaining an aseptic (or sterile) field during a surgical procedure depends upon astute, well- trained
staff to protect the patients from exposure to infectious organisms. Whenever there is a protective barrier
such as the skin, the risk for infection is significantly reduced. During eye surgery, the integrity of the eye
is compromised, thus putting the patient at risk of a postoperative infection or complication. The content
of this course will focus primarily on cataract surgery because it is the most common procedure in
ophthalmic ambulatory surgery centers across the nation.
One of the ophthalmic-specific complications of inadequate or improper processing of instruments is toxic

anterior segment syndrome (TASS), a rare complication of eye surgery that can have devastating
effects.1 It occurs when a non-infectious agent enters the anterior chamber of the eye and causes an
inflammatory reaction. This inflammatory response can lead to severe visual impairment. Cleaning agent
residues, endotoxins, bioburden (residual biological tissue living on a surface), denatured ophthalmic
viscoelastic agents, preservatives, and residues from sterilization processing all can induce toxic anterior
segment syndrome and damage ocular tissue severely.2 For this reason, those responsible for cleaning
and reprocessing surgical instruments must be diligent in decontamination and sterilization.
© 2011, BSM Consulting 1

WHAT ARE PRIONS? 13
Prions are the infectious agents that cause Creutzfeldt-Jakob disease, a progressive neurological
disease with a very low incidence (one in 1 million). However, prions are difficult to kill, and are resistant
to virtually every known disinfection and sterilization method. The World Health Organization has
identified eye tissue as high-risk tissue for contamination with prions from individuals infected with the
disease. Identification of high-risk patients is difficult because of the long incubation period.
Furthermore, flash sterilization is contraindicated for prion-contaminated devices. Where prion
contamination is suspected, quarantine the instruments in question and follow AAMI, CDC and World
Health Organization policies as appropriate.
Another serious consequence of improperly sterilized instruments in ophthalmic surgery is an infection

called endophthalmitis. With any ocular surgery, the risk for the patient to develop endophthalmitis exists,
and improper decontamination or sterilization of instruments increases this postoperative threat to a
patient’s vision. Endophthalmitis can lead to devastating outcomes, including blindness and loss of the
eye. If identified early and treated early, endophthalmitis can be resolved successfully, with minimal to no
visual consequence.
There is no substitute for maintaining an aseptic environment. Should any break in aseptic technique
occur, it must be reported and/or corrected immediately. Even with the best intention, human error occurs.
It is important to understand that admitting to such an error is a requirement for staff handling sterile
instruments.
THE SPALDING CLASSIFICATION SYSTEM FOR STERILIZATION

In 1968, Earle Spaulding of Temple University in Philadelphia developed a system classifying medical
instruments by their use and the risk of infection involved. This system classifies an instrument as critical,
semi-critical, or non-critical. This classification then will determine the guidelines for cleaning that
instrument in order to best prevent infection. Both the U.S. Centers for Disease Control and Prevention
(CDC) and the U.S. Food and Drug Administration (FDA) guidelines are based on the Spaulding
Classification System.
“Critical devices” such as surgical equipment and instruments that enter sterile body cavities are
classified as critical equipment and must be sterilized. The sterilization process kills or inactivates all
microbes, including bacterial endospores, an inactive form that certain bacteria assume under conditions
of extreme temperature, dryness, or lack of food.
“Semi-critical devices” come into contact with non-sterile mucous membranes or non-intact skin, and
must either be sterilized or receive high-level disinfection. High-level disinfection inactivates all vegetative
bacteria, mycobacteria, fungi, and viruses, but not necessarily all bacterial endospores.
“Non-critical devices,” such as blood pressure cuffs, stethoscopes, and stretchers, come into contact
with intact skin. These items require cleaning with a low-level disinfectant or detergent and water,
depending on the degree of contamination.

The following table illustrates the Spaulding classifications:
TABLE 1: CLASSIFICATION OF DEVICES, PROCESSES, AND GERMICIDAL PRODUCTS

Device Spaulding Cleaning EPA Product
Examples
Classification Process Classification Classification
Implants, scalpels,
needles,
phacoemulsification Sterilization—sporicidal
Critical (enters sterile Sterilizing
machine handpiece, I/A, chemical; prolonged
tissue or bloodstream) agent/disinfectant
forceps, scissors, hooks, contact
cannulas; other surgical
instruments
Laryngoscopes, High-level disinfection- Sterilizing
endoscopes, sporicidal chemical; short agent/disinfectant
endotracheal tubes, and contact
Semi-critical (touches other similar instruments
mucous membranes) Disinfectant with label
Intermediate-level claim for tuberculocidal
Hydrotherapy tanks
disinfection activity; HIV/HBV
activity
Noncritical (touches Disinfectant without

intact skin and Stethoscopes, tabletops, label claim for
Low-level disinfection
environmental waiting room chairs tuberculocidal activity;
surfaces) HIV/HBV activity
Rutala W.A. APIC Guidelines for Selection and Use of Disinfectants. American Journal of Infection Control 1996;
24:315.
CLEANING
Cleaning—the physical removal of all visible soil, dust, and other foreign materials—is the first and most
important step before disinfection and sterilization can occur. Presoaking may be necessary to prevent
soils and proteins from drying on surgical instruments. Presoaking softens the organic matter and buildup
of organic matter and ideally should occur immediately after the surgical procedure. Biofilm is a buildup
from water and cleaner and can cause sterilization to be ineffective—presoaking helps to prevent buildup.
All instruments to be disinfected or sterilized first must be cleaned thoroughly to remove all organic matter
and other residue. This must precede the disinfection and sterilization procedures, because organic
matter will shield organisms from destruction and may inactivate some disinfectants. Disinfection time
increases when more organisms are present. Manual cleaning follows presoaking: Instruments may be
washed while submerged underwater in order to prevent potential exposure to microorganisms through
aerosolization and splashing. The cleaning process must be carried out in a controlled environment using
standard precautions. Label directions on cleaning agents must be carefully followed to ensure a proper
concentration of cleaning solution. Balanced salt solution can damage delicate surgical instruments and
should never be used for cleaning (when balanced salt solution comes into contact with a surgical
instrument, it should be removed as soon as possible). Distilled water should always be used for soaking
and cleaning. Items to be sterilized must be inspected for cleanliness and absence of defects. Items to be
sterilized should also be tested for functional integrity when applicable.
Standard precautions require personnel to use appropriate personal protective equipment, such as
gloves, masks, gowns, and protective eye wear whenever splashing is anticipated. Cleaning products
may be harmful, and staff should always follow the manufacturer’s guidelines when using products. The
material safety data sheet on the chemical solution will provide a reference for the necessary personal
protective equipment. Proper ventilation, humidity control and temperature should be maintained in the
cleaning area. In the clinical setting, clean and dirty items must be kept separate at all times. Soiled
instruments can harbor bacteria and viruses, and should never be cleaned nor stored near clean or

sterilized instruments or supplies. To the extent possible, clean supplies should be maintained in a
different room or area away from soiled instruments.
All used supplies and equipment are considered contaminated even when contamination might not be
visible to the eye. Contaminated items, such as phaco handpieces, microscope handles, I/A, cannulas,
etc., should be collected into a container. The container must be covered, and the soiled instruments and
devices transported to the “soiled utility room” or decontamination area in a manner that minimizes
potential contamination of staff, patients, or the environment. Soiled disposable items should be collected
into a trash bag and disposed of per facility policy. Dispose of all used, disposable, sharp items (such as
blades, suture needles, etc.) in an approved sharps container.
There are three steps in the cleaning process: disinfection, rinsing and drying.
Disinfection
The selection of disinfecting agents is based upon the intended use of the instrument in the Spalding
Classification Table. In this step of the process, it is important to understand the degree of disinfection, as
well as the turnaround time, necessary for the surgical instrument in question. The following agents may
be used in the disinfectant process:
 Antiseptic: An antiseptic is a chemical agent for use on skin or tissue. It should not be used as a
disinfectant unless label instructions permit. It is important to understand the actions of different
products and to always use them appropriately to avoid injury and to effectively prepare
instruments or equipment.
 Disinfectant: A disinfectant is a chemical agent that inactivates most recognized pathogenic

microorganisms. The required disinfection may be low-, intermediate-, or high-level.
o Low-level disinfection is used for cleaning non-critical medical equipment and devices as
well as environmental surfaces. Quanternary ammomium compounds, sometimes called
quats, are low-level disinfectants. Most of these compounds are effective against
tuberculosis and hepatitis B, and are typically appropriate for blood spills and the
operating-room environment. There should be a written procedure regarding cleaning of
all environmental surfaces and equipment, indicating the person responsible, what is to
be cleaned, the frequency of cleaning required, and how the equipment or surface is to
be cleaned. CMS requires compliance with manufacturer guidelines.
o Intermediate-level disinfectants kill most viruses and fungi. Phenolic disinfectants or

quaternary ammonium chlorides (commonly known as “quats”) are indicated for cleaning
surfaces, floors, and non-critical medical devices and equipment.
o High-level disinfection is a process usually using liquid chemicals or wet pasteurization

that eliminates many or all pathogenic microorganisms on inanimate objects. High-level
disinfection might not eliminate large numbers of bacterial spores completely.3 When
using high-level disinfectants, follow the label directions carefully for soak time,
temperature, shelf life, and product restrictions. Use high-level disinfectants in a well-
ventilated area, and wear proper personal protective equipment.
Surgical instruments and equipment must go through a cleaning and decontamination process. Once
items are cleaned and decontaminated, a method of sterilization may be chosen.
Rinsing
Rinsing, which removes the loosened debris (or biofilm), is the most important part of the cleaning and
decontamination process. Use distilled or demineralized water for the final rinse to prevent the buildup of
mineral deposits and to reduce the potential for pyrogens (toxic substances).


QuickRinse and accessories.
QuickRinse™ is an automated instrument rinsing system that standardizes post-surgical care of reusable
instruments and tubing before sterilization. This system is especially helpful to facilitate thorough rinsing
of tiny cannulas. The system uses both liquids and air for removing biofilm from inside cannulas.
QuickRinse.
QuickRinse™ Features:
 Rinses phaco and I/A handpieces, cannulas, vitrectomy cutters, reusable tubing, and any
other micro-surgical instrument with a lumen
 Replaces syringe rinsing methods
 Helps reduce damage to instruments from excessive handling
 Provides automated cycles for consistent rinsing and air drying with a manual override
feature4
Drying
Drying reduces the risk of re-contamination during inspection and assembly of instruments, and
minimizes rusting and staining. Residual moisture interferes with the sterilization process and can
damage instruments. With a particle-free cloth or an air-drying machine, dry instruments after any method
of cleaning (pre-cleaning, manual, mechanical, and ultrasound).
The recommended practices of the Association of periOperative Registered Nurses (AORN) for cleaning
and caring for surgical instruments stipulates checking instruments for functionality, and inspecting and
preparing them for storage and sterilization after decontamination. Visually inspect instruments for the
following:
1. Cleanliness

2. Proper functioning and alignment

3. Corrosion, pitting, burrs, nicks, and cracks

4. Dullness of cutting edges

5. Any other defects5
When working on instruments with removable parts, the instruments should be disassembled and then
placed in trays designed for sterilization. Sterilize any ring-handled instruments in an open position.
Protect delicate and sharp instruments according to manufacturers’ written instructions. Instruments to be
stored after cleaning and decontamination should be dried thoroughly.
The surgeon is trained to inspect each instrument visually with the microscope in the operating room
before use. Instruments in disrepair should be replaced, or labeled and taken out of service until repaired.
INSTRUMENTS USED IN OPHTHALMIC SURGERY

A cataract is a clouding of the eye's natural crystalline lens. Cataract surgery involves removal of this
lens. All operating rooms equipped for intraocular surgery will have at least one phaco machine. The
phaco sends ultrasonic vibrations to the handpiece, which is inserted through an incision into the cloudy
lens that constitutes the cataract. Vibrating at about 40,000 cycles per second, the handpiece emulsifies,
or breaks up, the cataract into pieces so small that they can be vacuumed from the lens capsule through
the hollow center of the handpiece. At the same time, it introduces an irrigation solution that maintains
pressure and prevents the eye from collapsing.
The INIFINITI® Vision System by Alcon for phacoemulsification.
Ophthalmic Surgical Instruments
Note: A sample of many of the instruments used in ophthalmic surgery appears in a table at the end of
the course.
Microsurgical instruments are very delicate. It is important that each staff member working with the
instruments during the cleaning process is well-trained on the proper procedures not only for cleaning and
for sterilization, but also on proper care and handling of the instruments. Surgical instruments are very
expensive, and many are designed by or for a particular surgeon. In fact, the last name of the physician
who designed the instrument often precedes the name of the instrument.
Care of Diamond Knives
Many ophthalmologists prefer to use a diamond-blade knife for making incisions during cataract surgery.
A diamond knife blade is much sharper than stainless steel and is much more expensive, requiring great
care in handling. Never wipe a diamond blade. A diamond blade knife should be cleaned immediately
after use to prevent buildup of bioburden, which may damage the knife. Retract the knife when not in use.
To clean a diamond knife, use the following procedure:
 Never apply excessive side-to-side motion, and never force the diamond knife, as it may affect
calibration.

 Extend the blade.
 Clean the blade in hydrogen peroxide for approximately two minutes.
 Immediately rinse for two minutes in distilled water.
 Retract the blade before sterilizing.
AORN (www.aorn.org) recommends keeping instruments free of gross soil during surgical procedures.
Instruments should be wiped with sponges moistened with sterile distilled or demineralized water to
prevent corrosion, rusting, and pitting, which occurs when blood and debris dry in or on surgical
instruments. Instruments with lumens or cannulas should be irrigated with sterile water to prevent
obstruction with organic material. Instruments should be wiped down and cleaned continually during the
course of the procedure.6
When necessary, clean instruments manually using a mild soap solution (such as Manu-Klenz) in distilled
water, then gently scrub the instruments with a small brush. Pay particular attention to the joints, serrated
edges, etc., which are places where corrosion may develop. Never use metal brushes, steel wool or
abrasive cleansers on surgical instruments.
The cleaning and decontaminating of instruments must be performed in a timely manner after use.
Instruments should be taken apart and arranged in an orderly fashion in mesh-bottom trays so that all
surfaces are exposed to the action of an automated cleaner, if used. Complete the following activities
when cleaning and decontaminating instruments:
1. Open instrument box locks.

2. Place heavy instruments on the bottom of the tray or in a separate tray.

3. Place scissors and lighter-weight instruments on top.

4. Separate all reusable, sharp instruments from general instruments.

5. Cover instruments with a damp towel to prevent drying during transport to the decontamination
area.
Ultrasonic Cleaning
In the ambulatory surgery center, typically adjacent to the operating room is the soiled utility room where
instrument cleaning and decontaminating occurs. Ultrasonic cleaning and instrument washers
supplement manual cleaning of delicate tubes or other hollow instruments, such as special syringes or
needles. When using an ultrasonic cleaning process, combine only instruments made of similar metals in
the ultrasonic cleaner to avoid ion transfer, which may result in instrument etching and pitting. The phaco
handpieces should not be placed in the ultrasonic cleaner. Ultrasonic cleaners work by subjecting
instruments to high-frequency, high-energy sound waves, which produce tiny bubbles that implode,
resulting in a scouring action that cleans.7 Ultrasonic cleaning is effective in removing soils from hard-to-
reach areas.
The process for using ultrasonic cleaners follows:
 Remove all gross soil from instruments before placing in the ultrasonic cleaner.
 Follow the manufacturer’s recommendation when choosing a neutral or alkaline, low-foaming

detergent specifically indicated for use in your ultrasonic cleaner. Do not use household cleaners.
 Make certain that the water in the ultrasonic cleaner is approximately 150 degrees Fahrenheit (65
degrees centigrade). Some ultrasonic cleaners have built-in heaters. If the ultrasonic cleaner
does not have a heater, use water heated in a separate container.

 Do not use foam, because it settles on instruments when they are removed from the tank.
 Place instruments in a wire or perforated basket before placing them into the cleaner in order to
protect delicate instrument tips.
 Avoid placing rubber items in the ultrasonic cleaner, because these items absorb the vibrations
created.
 Thoroughly rinse instruments under running water upon removal from the ultrasonic cleaner and
then rinse with distilled water.
 Change the solution frequently, based upon the volume of instruments cleaned. At a minimum,
you should empty, clean, rinse, and dry the unit at least once per day. The operation and
maintenance of ultrasonic cleaners should follow the manufacturer’s instructions.
Ultrasonic Cleaner
Packaging Materials for Sterilization8
After the instruments are clean, it is necessary to package the instruments before sterilization. Items may
be packaged individually (e.g., scissors) or assembled into trays and sets. Frequently, some items are
packaged both individually and as part of a tray or set. In any case, it is important to select the
appropriate packaging materials. Wrappers and peel packs are Class II medical devices, and the
manufacturer must submit a 510(k) to the FDA to obtain clearance. The manufacturer should be able to
provide technical information for the product. It is imperative to adhere to the manufacturer’s written
instructions for each specific wrapper, regardless of whether it is disposable or reusable.
The following packaging materials are available for sterilization:
PACKAGING MATERIALS
1. Cloth: minimum 140 threads per square inch
2. Wovens (muslin/synthetics)
3. Non-wovens (paper)
4. Polyolefin (plastic-based)
5. Peel packs (paper/plastic pouches/roll)
6. Sterilizing trays or cases
When evaluating packaging materials, always obtain and keep on hand the packaging manufacturer’s
technical data verifying that the material has been tested and validated for the appropriate sterilization
methodology. Always follow the packaging manufacturer’s written instructions for use.
Single-ply or double-ply, non-woven, disposable wrapping material is preferable. Woven textiles generate
lint and require ongoing maintenance. Since most eye instrument sets are small and lightweight, heavier-
weight wrappers are not necessary. Some wraps are more difficult to dry.

Paper or plastic peel packs should be used only for single, lightweight items to prevent damage to the
seals during sterilization. They are not intended for trays or heavy items. It is important to use the correct-
size pouch. (There should be approximately one inch of space around the device.) Peel packs should not
be placed inside wrapped sets or rigid containers. The use of tip protectors is recommended to protect
instruments and prevent damage to the packaging materials.
AORN recommends packaging items to be sterilized according to established guidelines. Items should be
prepared and packaged to achieve and maintain sterility to the point of use. Manufacturers of packaging
systems should be consulted for preparation, configuration, and sterilization recommendations. The
packaging must allow for presentation of the package contents to the sterile field in an aseptic manner.
Instruments should be processed in an open and unlocked position. This is necessary so that all surfaces
of the instrument are exposed during sterilization. Additional packaging materials inside a set can
interfere with sterilization efficacy and drying.
When using instrument sterilization container systems, follow the manufacturer’s written instructions for
maximum weight, set preparation, sterilizer loading procedures, exposure times, and drying cycles.
Plastic trays or cases are best-suited for single or small instruments. These plastic trays or cases have
short life spans, and are relatively inexpensive and easy to use. Containing many small silicone nubs,
these trays are designed to protect delicate instrument tips. The nubs may be cut or altered to
accommodate the shape of the instrument. Take care to prevent the tip from coming in contact with the
sides of the case. Gently rubbing a hand over the nubs will ensure that no instrument is protruding before
putting the lid on the case.9
Packaging Label Information
Prior to sterilization, each package is labeled according to established policy and procedure. A label
should list the package contents, lot control number, initials of the person processing the item, and the
date of sterilization. Sterilized items also should have load control identification indicating the sterilizer
used, the cycle or load number, and the date of sterilization. Sterilizer equipment must have regular
maintenance, and loads must be documented. Mechanical, biological, and chemical monitoring of
sterilized loads is necessary in the ASC. The tracking system may vary according to facility protocols. It is
essential that staff carry out all required testing and labeling of packaging.
STERILIZATION10
Sterilization is the process of destroying all microorganisms, including bacterial endospores. Sterilization
should be used for instruments and other items that come in direct contact with sterile tissue or the
bloodstream. For sterilization to be effective, instruments must be thoroughly cleaned and rinsed
beforehand, regardless of the method.
The sterilization procedure also requires time, contact, temperature and—with steam sterilization, high
pressure—to be effective. All surfaces of a surgical instrument must be exposed for sterilization to be
successful. The effectiveness of any sterilization method depends on the number and type of
microorganisms, the amount and type of organic matter that protects them, and the number of cracks and
crevices on an instrument that might harbor microorganisms.
Important note: It is incumbent on the end user to follow manufacturer guidelines at all times. Policies and
procedures for the office and/or the ambulatory surgery center must adhere to these guidelines.
Manufacturers must provide end users with written instructions for proper cleaning and sterilization. This
information is developed based upon their testing and validated cleaning and sterilization methods
(Association for the Advancement of Medical Instrumentation (AAMI ST81). This is especially relevant in
specialty devices, which, because of material composition or design of the device, might require a
particular water quality (i.e., distilled), cleaning chemicals, cleaning implement, preparation, and special
sterilization cycles. It is vital to patient safety that this information is obtained and followed. Staff should
store the manufacturer’s guidelines should be stored in binder or protected area close to the equipment
for easy access and reference. During a CMS survey, the ASC will be required to produce this
information/documentation and validate that the ASC is following manufacturer guidelines.


METHODS OF STERILIZATION IN OPHTHALMIC SURGERY
Sterilization may be thermal or chemical, and there are four methods: high-pressure steam sterilization,
flash sterilization, ethylene oxide sterilization, and dry heat sterilization.
High-Pressure Steam Sterilization
The usual method of sterilization for eye instruments is steam under pressure or steam prevacuum (pre-
vac) sterilization. It is inexpensive, convenient, nontoxic, and easy to use. Steam under pressure, or
autoclaving, sterilizes both porous and nonporous materials relatively quickly.
With this system, a vacuum pump mechanically removes the air in the sterilizer, allowing its immediate
replacement with saturated steam. When the steam has displaced the air, the temperature and steam
pressure build until the device reaches operating temperature (270-275 degrees). The operating
temperature, the temperature at which sterilization occurs, is maintained for the remainder of the cycle
time. This dynamic air-removal system reduces the total cycle time over a gravity displacement system by
allowing the sterilizer to reach the operating temperature and pressure more quickly. Steam sterilizers
vary in design and performance characteristics; therefore, the device manufacturer’s recommended cycle
parameters should match the sterilizer manufacturer’s written instructions for the specific sterilization
cycle and load configuration.
Take care not to put too many packages or trays of instruments in the autoclave: Wrapped trays and peel
packages should be arranged so that the steam can surround and penetrate the packages adequately
and completely. The autoclave manufacturer can provide assistance and training in the proper loading of
the autoclave.
Autoclave
Packages should be thoroughly dried and cooled before handling or removal from the sterilizer. Items
may contain steam vapor after the sterilization cycle and appropriate drying time; therefore, touching
packages at this time could compromise the packaging material by causing moisture to wick through the
wrapper. If any liquid breaches the packaging material, items inside the package are considered unsterile.
Monitoring Steam Sterilization
The AAMI and AORN recommend monitoring all sterilization cycles. Steam under pressure is the usual
method of sterilization for eye instruments.
Sterilization cycles should be monitored in the following ways:
 Mechanically: by reviewing the printout or chart at the end of each cycle.
 Chemically: by placing a chemical indicator inside and outside each package to be sterilized.
 Biologically: by using biological indicators (spore tests) at least weekly.

Flash Sterilization
A flash sterilizer is a special-purpose pressure autoclave for sub-sterile or operating rooms. AORN
guidelines stipulate using flash sterilization under emergency circumstances when the preferred method
of sterilization is not possible.11 Items sterilized in this manner must be used immediately, and special
care is necessary to prevent contamination during transfer to the sterile field. Always refer to the
manufacturer’s written instructions regarding the use of flash sterilization.
Common STATIM Sterilizer
Flash sterilization should not be used as a substitute for sufficient instrument inventory. Flash sterilization
may be associated with increased risk of infection because of pressure on personnel to eliminate one or
more steps in cleaning and sterilization. Following all the steps in the sterilization process in a
conscientious manner is essential.
Before flash sterilization, instruments should be cleaned and dried thoroughly. Proper decontamination is
essential in removing bioburden and preparing an item for sterilization by any method. Packaging and
wrapping should not be used in flash sterilization cycles unless the sterilizer specifically is designed and
labeled for this use. Specialized flash sterilization containers should be used and cleaned according to
manufacturers’ written instructions. Flash sterilization should not be used for implantable devices such as
intraocular lenses (IOLs).
Monitoring Flash Sterilization:
Each flash sterilization cycle should be monitored to verify meeting parameters. Monitoring flash
sterilization necessitates the following procedures:
 The sterilizer operator should record and verify time and temperature for each cycle and verified
before transferring the item to the point of use.
 Monitor sterilizer function with mechanical, chemical, and biological indicators to meet all of the
standards for gravity displacement and prevacuum sterilizers.
 Maintain documentation to allow for traceability of every load to the patient.
 A sterilization log should include information on each load, such as the device(s) processed, the
patient receiving the item(s), and the reason for flash sterilization.
Ethylene Oxide12
Ethylene oxide (EO) sterilization uses a toxic gas to alkalinize microorganisms and kill them. It is used for
moisture-sensitive instruments that cannot be steam sterilized. Ethylene oxide gas is the most common
and effective method of terminal sterilization for medical instruments that cannot be autoclaved. Ethylene
oxide gas is the preferred alternative for equipment that must be stored sterile and ready for use,
although the time necessary to process through an entire sterilization cycle can be up to 14 hours.
EO-sterilized instruments will have a lengthy aeration time after each cycle to allow removal of harmful
residuals before opening the chamber door. The aeration time varies by manufacturer, but can be

between 12 and 24 hours. Instruments that must be sterilized using the ethylene oxide method can be
used only once in a 24-hour period.
Compatibility of materials with EO sterilization should be established before using this method.
Mechanical monitors of EO sterilizers should record the parameters for sterilization, including
temperature, exposure time, relative humidity, and sterilant concentration. Documentation of EO-
processed items should include the assigned lot number, contents of each load, and results of
mechanical, chemical, and biological monitors.
All EO-sterilized items must be aerated completely before safe use is possible. Ethylene oxide is a known
carcinogen and can have harmful effects on patients and personnel. If instruments are not completely dry
before EO sterilization, a potent hemolytic (destructive to red blood cells) agent can form, which also can
have ill effects on the patient.
The U.S. Occupational Safety and Health Administration (OSHA) has very strict guidelines for EO
exposure, and policies and instructions, such as training on alarms and ventilation, are essential for EO
use. Regular exposure testing of areas and personnel is necessary.
Dry Heat Sterilization
Dry heat sterilization is accomplished by thermal (heat) conduction at a temperature of 340F for one hour
(60 minutes). Initially, the exterior surface of an item absorbs heat and then passes it to the next layer.
Eventually, the entire object reaches the temperature necessary for sterilization. Dry heat kills micro-
organisms by slowly destroying protein, and dulls and corrodes instruments less than other methods. This
method of sterilization is not common because it requires high temperatures and a long exposure time. It
is typically used for powders and oils that can tolerate prolonged high temperature.
Documentation
Use a log form to document all items processed in each method of sterilization. Each item processed in
each load/cycle should be identified with a lot control number consisting of the date of sterilization,
sterilizer number, and cycle number. This information can be used to track devices in the event of a
sterilizer malfunction.
Quality Control
Sterilization methods in the ambulatory surgical setting are so important that the quality assurance
committee will monitor all reports, processes, and methods at least quarterly. This is a requirement by not
only CMS, but also of accreditation bodies. The ASC must show and document all reporting mechanisms,
action plans for improvements, tracking procedures, and maintenance of appropriate logs. Quality control
measures include but are not limited to:
1. A comprehensive employee orientation program
2. Continuing education programs at least annually
3. Occurrence tracking
4. Sterilizer maintenance history
5. Sterilization process monitoring with chemical indicators and biological devices
6. Air removal testing
7. Visual inspection of packaging materials
8. Lot control and traceability of load contents

Basic Sterile Techniques
Constant monitoring and maintenance of the sterile field is essential. In the ASC setting, the circulating
nurse is responsible for observing potentially contaminating events, and will initiate and follow through
with the appropriate action to restore the sterile field should a breach occur. Once established, the sterile
field should not be recovered nor moved from one place to another because of the risk of contamination.
Any person moving around a sterile field must do so in a manner that will not compromise the field. Any
person who is not “surgically clean” or scrubbed in for surgery should always face the sterile field.
Operating room doors must be kept closed except during the movement of personnel and equipment.
Never reach over or touch a sterile field when non-scrubbed. Take extreme care at all times to ensure
that unsterile items never touch the sterile field.
It is essential for staff to be able to distinguish between sterile and non-sterile equipment and items in the
operating room. It is important to recognize and to identify the difference between the surgically clean
team member who is scrubbed in for surgery and the team member who is not, such as the circulator or
an observer. For example, items on the sterile field including instruments, as well as the phaco hand
pieces and the microscope handles, are sterile and must be changed between cases. If any team
member accidently touches anything that is not sterile, such as the non-sterile parts of the phaco machine
or the microscope, that team member must don new sterile gloves. Depending on break in sterile
technique, the scrub tech might need to change his or her gown and gloves. If there is any doubt,
consider the field and the person contaminated and take appropriate action. While setting up for a case,
cover the back table and mayo stand with sterile drapes. Sterile instruments and devices are then set up
on the table and mayo stand. The operating room must be kept as clean as possible throughout the
surgical day.
Cleaning activities after each case should include:
1. Disposing of all soiled linen and other waste materials into properly bagged receptacles.
2. Wiping down with a disinfectant solution the procedure table, basins, stands, and mayo stand, as
well as any other equipment used during the procedure.
3. Removing soiled linen and waste bags, and bringing them to the appropriate holding area for
pickup by the carting services(s).
Cleaning should include:
1. Mopping the floor with disinfectant solution at the end of the day.
2. Wiping off all horizontal surfaces with disinfectant solution if any suspected contamination occurs
at the end of the day.
3. Wiping all stretchers with disinfectant solution between each patient and at the end of the day.
4. Wiping all equipment, such as blood pressure machines, IV poles, phaco machines, etc., with
disinfectant solution between each patient and at the end of the day.
5. Wiping doors of cabinets and room, especially around handles and push plates.
6. Damp-wiping all overhead lights with disinfectant solution.
7. Washing wall surfaces with disinfectant solution.
8. Damp-wiping all furniture and equipment, including wheels and casters.
9. Cleaning vents monthly or more frequently, if necessary.
10. Emptying trash and linen between each patient, and at the end of the day.

PRINCIPLES AND RECOMMENDATIONS
The Journal of Cataract and Refractive Surgery (Vol. 33, June 2007), has issued General Principles of
Cleaning and Sterilizing Intraocular Surgical Instruments and Recommendations for Cleaning and
Sterilizing Intraocular Surgical Instruments. They are as follows:
General Principles of Cleaning and Sterilizing Intraocular Surgical Instruments14
1. Keep instruments moist until the cleaning process begins to avoid drying of debris.
2. Use the quality and volume of water per manufacturer’s directions for use for diluting or mixing of
detergents and for cleaning and rinsing instruments. Many intraocular instruments require sterile
distilled or sterile deionized water for proper cleaning. Sterile distilled or sterile deionized water is
necessary for final rinsing.
3. Follow detergent and instrument manufacturer’s recommendations to ensure proper use of the
detergent and to ensure compatibility with the instruments. Add only the amount specified; too
much cleaner may cause biofilm or tackiness, which inhibits thorough cleaning of the instrument.
4. Rinse instruments to remove all cleaning agents as well as all debris loosened during cleaning.
5. Use the method of sterilization approved by the instrument and the sterilizer manufacturers.
6. Maintain sterilizers in accordance with the manufacturers’ recommendations.
7. Make available to all staff the written policies and procedures for cleaning and sterilization.
8. Allow adequate time for completion of all steps of cleaning, decontamination, and sterilization.
9. Implement staff training, competency validation, and periodic performance review.
Recommendations for Cleaning and Sterilizing Intraocular Surgical Instruments15
1. Ensure adequate time for thorough cleaning and sterilization of instruments.
a. Adherence to recommended procedures for cleaning and sterilizing surgical instruments

should never be circumvented to save time and money.
b. Inventory of instruments should be sufficient to meet surgical volumes and to provide

adequate time for completion of cleaning and sterilization.
c. Flash sterilization should be used only when there is insufficient time to process by the
preferred wrapper or container method. Insufficient inventory does not justify use.
2. Follow the manufacturer’s recommendations for cleaning and sterilization for each instrument or
piece of equipment.
3. Do not allow ophthalmic viscosurgical device solution, which harden within minutes, to dry on the
instruments.
a. Wipe instruments with a damp, lint-free cloth, and flush or immerse instruments in sterile
water in the operating room immediately after use. Keep sterile water basins used for
cleaning or soaking soiled instruments in areas separate from the operative field and
removed from sites that maintain instruments necessary to complete the procedure.
b. Flush cannulated instruments in the operating room or the decontamination room, or

both, according to the manufacturer’s instructions.

4. Transport all instruments opened for a procedure from the operating room in a closed container to
the decontamination room. Even instruments not used for the procedure are contaminated once
opened. Clean immediately.
5. Use disposable items whenever possible, and discard after each use.
6. Do not reuse or reprocess single-use items.
7. Clean intraocular instruments separately from non-ophthalmologic instruments to reduce

contamination with bioburden and cleaning chemicals.
8. If a detergent is used in the cleaning process:
a. Ensure that instructions for proper dilution, outdate, and disposal are followed. Mix the
cleaning solution with measured amounts of water and detergent according to the
manufacturer’s directions. Do not estimate volumes of water, detergent or both.
b. Rinse instruments with water to ensure removal of all detergent. Use of tap water for
rinsing and removal of detergent must be compatible with the manufacturer’s
recommendations for the detergent and the instrument/equipment. Use sterile water for
the final rinse.
9. If using an ultrasonic cleaner:
a. Ensure that gross soil has been removed from the instrument/equipment before
placement in the ultrasonic cleaner.
b. Check the manufacturer’s instructions to identify instruments that should not be subject to
ultrasonic cleaning.
c. Follow the manufacturer’s instructions for validating function, de-gassing, and preventive
maintenance.
d. Empty, clean, disinfect, rinse, and dry the ultrasound machine at least daily, and
preferably after each use.
e. Refill immediately before use.
10. Manual cleaning processes:
a. Use a brush for cleaning medical instruments. Small toothbrushes also work well for this
purpose. Cleaning or scrubbing with the instrument submerged underwater is preferable
in order to avoid splashing and aerolization of organisms.
b. If using brushes, they should be designed for reuse, and they should be cleaned, high-
level disinfected, or sterilized after each use, or at least daily.
c. Discard cleaning solution after each use.
d. Discharge effluent (liquid waste) used to flush instruments into a sink or separate basin
so that the fluid is not reused.
e. If using diamond blades, use of a pressurized steam cleaner is effective in removing the
bioburden that can remain on the blade.
11. Rinsing:
a. Select appropriate type of rinse water for each piece of equipment.

b. Use sterile water for the final rinse.
c. Rinsing should provide flow of water through and/or over instruments, with effluent
discarded as it is used, so only debris-free water is used for rinsing. QuickRinse™,
described earlier in this course, is very effective for rinsing tiny cannulas.
d. Do not use agitation in a basin of water as the final rinse.
12. Dry instruments with lumens with forced or compressed air:
a. Use compressed air that is filtered, and free of oil and water.
b. Dry instruments with lumens fully.
13. Care of specific instruments: phacoemulsifier handpiece, irrigator/aspirator, irrigator/aspirator tips,

and inserters:
a. Flush phacoemulsifier handpiece with balanced salt solution before removing from the
operative field.
b. Wipe each instrument with a lint-free cloth (such as a wet gauze sponge) and place in
sterile water.
c. Clean and flush (using QuickRinse™ if available) each item in accordance with the
manufacturer’s directions.
14. Verify cleanliness and integrity of instruments:
a. Visually inspect instruments for debris, corrosion and damage following cleaning prior to
sterilization.
b. Repeat cleaning and rinsing if necessary.
15. Sterilization:
a. Steam under pressure is the most common form of sterilization for intraocular surgical
instruments.
b. Glutaradehyde is not recommended for sterilizing intraocular instruments because of the

toxicity of residues resulting from inadequate rinsing or contamination during post-
sterilization handling.
c. Complete verification of sterilizer function before use, and document in the center’s log.
d. Perform maintenance, cleaning, and inspection of sterilizers on a scheduled basis. All

preventive maintenance must be documented.
e. Verify maintenance of boilers, or the water filtration systems, and of the quality of water
supplying the steam-sterilizing system at least annually.
CONCLUSION
There are many steps in the cleaning and sterilization process to follow to achieve successful sterilization.
Every procedure should be developed with patient safety in mind. Because all patients deserve quality
medical care with correctly processed equipment, it is essential to take great care to ensure the
appropriate method of sterilization for each instrument and device.

SOURCES
1. Chobin, Nancy. Providing Safe Surgical Instruments: Factors to Consider. Infection Control Today.
April 2008.
2. Chobin, Infection Control Today. April 2008.
3. APIC, Infection Prevention for Ambulatory Surgery Centers: Meeting CMS Conditions for
Coverage; September 2010.
4. The QuickRinse™ is manufactured by American Optisurgical, 25501 Artic Ocean, Lake Forest,
California.
5. AORN Standards, Recommended Practices, and Guidelines: Recommended Practices for Cleaning
and Caring for Surgical Instruments and Powered Equipment, 2005.
6. AORN Standards, Recommended Practices, and Guidelines: Recommended Practices for Cleaning
and Caring for Surgical Instruments and Powered Equipment, 2005.
9. Katena Instrument Care Booklet, Katena products, Inc., Denville, New Jersey.
10. Tietjen, Cronin and McIntosh. Sterilization. Infection Prevention Guidelines. 1992.
11. AORN Standards, Recommended Practices and Guidelines: Recommended Practices for Cleaning
and Caring for Surgical Instruments and Powered Equipment. 2005.
12. Young, Martha. AORN Recommended Practices for Sterilization in Perioperative Practice Setting.
Managing Infection Control. May 2006.
13. Chobin. Infection Control Today. April 2008.
14. Special Report: Cleaning and Sterilizing Intraocular Surgical Instruments. Journal of Cataract and
Refractive Surgery. Volume 33. June 2007.
15. Special Report. Journal of Cataract and Refractive Surgery. Volume 33. June 2007.

EXHIBIT 1

EXHIBIT 1: COMMON TYPES OF INSTRUMENTS USED IN OPHTHALMIC SURGERY

Note: Many ophthalmic instruments are preceded by the last name of the physician who designed the instrument
Type of Surgical Sample Photo:
Instruments Different brands may have a different appearance.
Irrigation
and Aspiration Hand
Piece
Air
Injection
Cannula
Anterior Chamber
Irrigator
Bipolar cord
(usually autoclavable)
Bipolar Forceps
(blunt tip)
Caliper

Capsulorrhexis
Forceps
Capsulotomy Scissors

Chalazion Forceps
Chalazion Curette
Conjunctiva Forceps
Cystotome (angled)
Diamond
Knife
Diamond
Knife
Diamond Knife for

micro incision cataract
surgery (MICS)
Disposable
Blade

Eyelid Speculum
Eyelid Speculum
Fixation
Ring
Hydro-dissection
Cannula
I/A or Irrigation and

Aspiration Hand piece

IOL
Cutter
IOL
Folder
IOL Inserting Forceps
Iris
Hooks

Irrigating-Aspirating
Cannula
Lens hooks:
Straight and/or
curved; (may be
referred to as a
Sinskey or a
Sinskey hook)

Limbal Relaxing
Incision (LRI) Marker
Mosquito Clamp
Needle
Holder
Nucleus Cracker
Pupil
Dilator

Soft
IOL
Cutter
Tenotomy Scissors
Towel
Clamp
Tying forceps:
straight and curved
Chalzion
Set
Photos courtesy of Katena Products, Inc.; www.katena.com; 800-225-1195.

COURSE EXAMINATION
1. The purpose of good care and handling of surgical instruments in a health care setting includes
all of the following except:
a. To decrease the risk of infection.

b. To promote safety.
c. To prolong the life of surgical instruments.
d. To create faster turnover time.
2. One complication of inadequate or improper processing of instruments is:
a. Pterygium.
b. Astigmatism.
c. Toxic anterior segment syndrome.
d. Blepharospasm.
3. Surgical equipment and instruments that enter sterile body cavities are classified as:
a. Semi-critical.
b. Sterile.
c. Noncritical.
d. Critical.
4. What type of cleaning is necessary for critical devices?
a. Low-level disinfection.
b. Sterilization.
c. High-level disinfection.
d. Antiseptic cleansing.
5. The sterilization process includes all of the following steps except:
a. Packaging.
b. Cleaning.
c. Disinfection.
d. Sterilization.
6. What is the most common method of sterilization for ocular surgical instruments?
a. Ethylene oxide.
b. Low temperature gas plasma.
c. Dry heat.
d. High-pressure steam sterilization.
7. The infectious agents that causes Creutzfeldt-Jakob disease are:
a. Bacterial spores.
b. Prions.
c. Fungi.
d. Blood.
8. The general principles of cleaning and sterilizing intraocular surgical instruments include all of the
following except:
a. Keep instruments dry until the cleaning process begins.

b. Flush cannulated instruments according to manufacturer’s instructions.
c. Remove all gross soil from instruments.
d. Thoroughly rinse and dry instruments after cleaning.

9. When using an ultrasonic cleaner, follow all of the following procedures except:
a. Ensure the removal of gross soil from the instrument.

b. Use a low-foaming detergent.
c. Follow manufacturer’s directions for use.
d. Place instruments of different metals in the ultrasonic cleaner.
10. Which of the following is not necessary for items that undergo flash sterilization?
a. Thorough cleaning, rinsing, and drying.

b. Packaging and wrapping.
c. Specialized containers.
d. Monitoring to verify that parameters have been met.
11. A stethoscope requires low-level disinfection.
a. True
b. False
12. Personal protective equipment is not needed for cleaning and decontamination of surgical
instruments and devices.
a. True
b. False
13. Drying reduces the risk of recontamination during inspection and assembly of instruments, and
minimizes rusting and staining.
a. True
b. False
14. Flash sterilization may be used routinely in facilities that do not have adequate inventory of
surgical supplies.
a. True
b. False
15. All surfaces of a surgical instrument must be exposed for the successful completion of
sterilization.
a. True
b. False

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BSM Connection™

Distance Learning Course

© 2011, BSM Consulting

THE IMPORTANCE OF STERILIZATION AND STERILE TECHNIQUE .................................... 1

THE SPALDING CLASSIFICATION SYSTEM FOR STERILIZATION........................................ 2

INSTRUMENTS USED IN OPHTHALMIC SURGERY ................................................................. 6

METHODS OF STERILIZATION IN OPHTHALMIC SURGERY................................................ 10

PRINCIPLES AND RECOMMENDATIONS ............................................................................... 14

EXHIBIT 1: TABLE OF COMMON INSTRUMENTS .................................................................. 19

COURSE EXAMINATION .......................................................................................................... 24

© 2011, BSM Consulting

This course will review the following:

1. Cleaning and decontamination of instruments.

2. Equipment and instruments for eye surgery.

3. Principles of cleaning and sterilizing intraocular surgical instruments.

4. Methods of sterilization for ophthalmic surgical instruments.

5. Recommendations for cleaning and sterilizing intraocular surgical instruments.

6. Basic techniques for ensuring sterile equipment in the operating room.

THE IMPORTANCE OF STERILIZATION AND STERILE TECHNIQUE

One of the ophthalmic-specific complications of inadequate or improper processing of instruments is toxic

© 2011, BSM Consulting 1

Another serious consequence of improperly sterilized instruments in ophthalmic surgery is an infection

THE SPALDING CLASSIFICATION SYSTEM FOR STERILIZATION

© 2011, BSM Consulting 2

TABLE 1: CLASSIFICATION OF DEVICES, PROCESSES, AND GERMICIDAL PRODUCTS

Noncritical (touches Disinfectant without

© 2011, BSM Consulting 3

 Disinfectant: A disinfectant is a chemical agent that inactivates most recognized pathogenic

o Intermediate-level disinfectants kill most viruses and fungi. Phenolic disinfectants or

o High-level disinfection is a process usually using liquid chemicals or wet pasteurization

© 2011, BSM Consulting 4

QuickRinse and accessories.

 Replaces syringe rinsing methods

 Helps reduce damage to instruments from excessive handling

INSTRUMENTS USED IN OPHTHALMIC SURGERY

The INIFINITI® Vision System by Alcon for phacoemulsification.

Ophthalmic Surgical Instruments

Care of Diamond Knives

To clean a diamond knife, use the following procedure:

© 2011, BSM Consulting 6

 Clean the blade in hydrogen peroxide for approximately two minutes.

 Immediately rinse for two minutes in distilled water.

 Retract the blade before sterilizing.

1. Open instrument box locks.

The process for using ultrasonic cleaners follows:

 Follow the manufacturer’s recommendation when choosing a neutral or alkaline, low-foaming

Packaging Materials for Sterilization8

The following packaging materials are available for sterilization:

© 2011, BSM Consulting 8

Packaging Label Information

High-Pressure Steam Sterilization

Monitoring Steam Sterilization

Sterilization cycles should be monitored in the following ways:

 Mechanically: by reviewing the printout or chart at the end of each cycle.

 Biologically: by using biological indicators (spore tests) at least weekly.

© 2011, BSM Consulting 10

Common STATIM Sterilizer

Monitoring Flash Sterilization:

 Maintain documentation to allow for traceability of every load to the patient.

Dry Heat Sterilization

1. A comprehensive employee orientation program

2. Continuing education programs at least annually

4. Sterilizer maintenance history

5. Sterilization process monitoring with chemical indicators and biological devices