Recommended Practices for Sterilization in the ... · 2008 Perioperative Standards and Recommended Practices 577 Saturated steam under pressure is the preferred sterilization method

he following recommended practices for sterili-zation were developed by the AORN Recom-mended Practices Committee and have beenapproved by the AORN Board of Directors. They

were presented as proposed recommended prac-tices for comments by members and others. Theyare effective January 1, 2008.

These recommended practices are intended asachievable recommendations representing what isbelieved to be an optimal level of practice. Policiesand procedures will reflect variations in practicesettings and/or clinical situations that determinethe degree to which the recommended practicescan be implemented.

AORN recognizes the various settings in whichperioperative nurses practice. These recommendedpractices are intended as guidelines adaptable tovarious practice settings. These practice settingsinclude traditional operating rooms, ambulatorysurgery centers, physician’s offices, cardiaccatheterization laboratories, endoscopy suites,radiology departments, and all other areas wheresurgery may be performed.

References to nursing interventions (I) used inthe Perioperative Nursing Data Set, second edition,(PNDS) are noted in parentheses when a recom-mended practice corresponds to a PNDS interven-tion.1 The reader is referred to the PNDS for furtherexplanation of nursing diagnoses, interventions,and outcomes.

PurposeThese recommended practices provide guidancefor sterilizing items to be used in the surgical envi-ronment. The creation and maintenance of anaseptic environment has a direct influence onpatient outcomes. A major responsibility of theperioperative registered nurse is to minimizepatient risk for surgical site infection. One of themeasures for preventing surgical site infections isto provide surgical items that are free of contami-nation at the time of use. This can be accomplishedby subjecting them to cleaning and decontamina-tion, followed by a sterilization process.2 Steam,ethylene oxide (EO), low-temperature hydrogenperoxide gas plasma, peracetic acid, ozone, anddry heat are sterilization methods that are used inthe health care environment. Sterilization providesthe highest level of assurance that surgical itemsare free of viable microbes.

Recommendation I

Items to be sterilized should be cleaned, decon-taminated, sterilized, and stored in a controlledenvironment and in accordance with AORN’s“Recommended practices for cleaning and caringof instruments and powered equipment”2 and thedevice manufacturer’s written instructions.

Effective sterilization cannot take place withouteffective cleaning. The process of sterilization isnegatively affected by the amount of bioburdenand the number, type, and inherent resistance ofmicroorganisms, including biofilms, on the itemsto be sterilized. Soils, oils, and other materials mayshield microorganisms on items from contact withthe sterilant or combine with, and inactivate, thesterilant.3,4

I.a. Functional workflow patterns should beestablished to create and maintain physicalseparation between the decontaminationand sterilization areas. (PNDS: I81, I98)

Physical separation aids in environmentaland microbial control. During manualcleaning of instruments, particulates,aerosolized matter, dust, and microbialcounts are elevated. Physical separation andvented airflow to the outside minimizescontamination of processed items.

I.a.1. Attire, use of personal protective equip-ment (PPE), and limitations in personnelaccess and movement should be basedon expected contamination levels(Table 1).

I.a.2. Functional workflow patterns should beestablished in the following order frompotentially high contamination areas to• clean areas:• decontamination,• preparation and packaging,• sterilization processing,• sterile storage, and • clean distribution.

I.a.3. Traffic patterns should be establishedthat define access restrictions, move-ment of personnel, and appropriateattire according to AORN’s “Recom-mended practices for traffic patterns in

Recommended Practices for Sterilizationin the Perioperative Practice Setting

2008 Perioperative Standards and Recommended Practices© AORN, Inc. All rights reserved.

575

T

the perioperative practice setting” toprotect personnel, equipment, supplies,and instrumentation from sources ofpotential contamination.5

I.b. Room temperature, humidity, and ventila-tion should be controlled in accordancewith local, state, and federal policy and reg-ulation. Table 2 provides parameters for thecontrolled environment.3 (PNDS: I81, I98)

Bacteria and fungi thrive at warm temper-atures; cooler temperatures may impedebacterial and fungal growth in the deconta-mination area. Regulated environmentalcontrols in work areas are essential for thecomfort of personnel wearing appropriateattire and PPE.3

I.c. Room temperature, humidity, and ventila-tion for each work area should be moni-tored and recorded daily.3 (PNDS: I98)

I.c.1. Organizations should monitor and recordenvironmental controls in each area toensure that, at minimum, recommendedparameters are met and maintained.

I.d. Health care personnel should refer to the“Recommended practices for cleaning andcare of surgical instruments and poweredequipment” and must use standard precau-tions when performing decontaminationactivities.2 (PNDS: I70, I98)

Standard precautions are designed toprotect patients and health care workersfrom contact with recognized and unrecog-nized sources of infectious diseases.

Recommendation II

Items to be sterilized should be packaged inaccordance with AORN’s “Recommended prac-tices for selection and use of packaging systemsfor sterilization.”6

Appropriate packaging ensures that sterility canbe achieved and maintained to the point of use.

II.a. Manufacturers of packaging systems shouldbe consulted for package preparation, config-uration, and sterilization.6,7 (PNDS: I70: I98)

II.b. The total weight of an instrument set shouldnot exceed 25 lbs. (PNDS: I122)

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2008 Perioperative Standards and Recommended Practices576

Work area Scrubs Head cover Gloves* Gown orapron#

Eye Protection+

Masks orface shields±

Decontamination X X X X X X

Preparation andpackaging

X X

Sterilization pro-cessing

X X

Sterile storage X X

*Gloves should be waterproof, general-purpose utility, or heavy duty.#Gowns must be liquid-resistant with sleeves. Aprons may be liquid-resistant but do not need to have sleeves.+Eye protection includes goggles/eye glasses with side shields or chin-length face shields. ± Masks should be fluid-resistant.

REFERENCE1. US Department of Labor, Occupational Safety and Health Administration. 29 CFR Bloodborne pathogens—

1910.1030, Occupational safety and standards, Appendix A. Federal Register. 1991;56:64004.

Table 1

ATTIRE AND PERSONAL PROTECTIVE EQUIPMENT REQUIREMENTS1

Instrument sets weighing more than 25 lbsare known to be difficult to dry withoutlengthy drying times and present an increasedrisk of ergonomic injury.3,8

II.c. Combination paper/plastic peel pouches should not be placed in a container orwrapped set.3,6 (PNDS: I70, I122)

It may not be possible to position pouchesto ensure adequate air removal, steam con-tact, or drying. The practice of using wraps orpouches inside container systems has notbeen validated by pouch or container manu-facturers. Medical-grade, all-paper pouchesmay be used for this purpose.3

Recommendation III

Saturated steam under pressure should be used tosterilize heat- and moisture-stable items unlessotherwise indicated by the device manufacturer.

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2008 Perioperative Standards and Recommended Practices 577

Saturated steam under pressure is the preferredsterilization method. It is an effective, inexpensive,and relatively rapid sterilization method for mostporous and nonporous materials.9

III.a. Manufacturers’ written instructions for oper-ating steam sterilizers should be followed.(PNDS: I98, I122).

Steam sterilizers vary in design and perform-ance characteristics. A variety of steam sterili-zation cycles are used in health care organiza-tions. Some examples are gravity-displacementcycles, dynamic air-removal (ie, prevacuum),steam flush pressure pulse cycles, flash cycles,and express cycles (ie, abbreviated steam steril-ization cycles used for flash sterilization).2 Inaddition, some sterilizers may be designed topermit only one type of cycle. For example,some sterilizers are identified as gravity-dis-placement sterilizers because that is the onlytype of cycle this type of sterilizer permits.

Table 2

PARAMETERS FOR CONTROLLED ENVIRONMENTS DURING STERILIZATION1 Functional area Airflow Minimum number

of air exchangesper hour

All air exhausteddirectly to the

outdoors

Temperature Relative humidity

Soiled/decontaminated

Negative (in) 10 Yes 60° F to 65° F(16° C to 18° C)

30% to 60%

Sterilizer equip-ment access

Negative (in) 10 Yes 75° F to 85° F(24° C to 29° C )

30% to 60%

Sterilizer loading/unloading

Positive (out) 10 Yes 68° F to 73° F(20° C to 23° C)

30% to 60%

Restrooms/housekeeping

Negative (in) 10 Yes ≤ 75° F(≤ 24° C)

30% to 60%

Preparation andpackaging

Positive (out) 10 (downdrafttype)

No 68° F to 73° F(20° C to 23° C)

30% to 60%

Textile packag-ing room

Positive (out) 10 (downdrafttype)

No 68° C to 73° F(20° C to 23° C)

30% to 60%

Clean/sterilestorage

Positive (out) 4 (downdraft type)

No ≤ 75° F (≤ 24° C)

≤ 70%

REFERENCE1. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79: 2006 Comprehensive Guide to

Steam Sterilization and Sterility Assurance in Health Care Facilities. Arlington, VA: Association for the Advancement ofMedical Instrumentation; 2006. Adapted with permission.

1. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79:2006 Comprehensive Guide toSteam Sterilization and Sterility Assuring in Health Care Facilities. Arlington, VA: Association for the Advancement ofMedical Instrumentation; 2006. Reprinted with permission.

Table 3 and Table 4 provide typical mini-mum sterilization times for gravity-displace-ment and dynamic air-removal steam sterili-zation cycles.3

III.b. Cycle parameters recommended by thedevice manufacturer should be reconciledwith the sterilizer manufacturer’s writteninstructions for the specific sterilization cycleand load configuration.3,10 Certain types ofequipment and implants (eg, some pneumati-cally powered instruments; specialty ortho-pedic, neurosurgery, trauma instruments)may require prolonged exposure times ordrying times.3,10 (PNDS: I98, I122)

III.c. Following steam sterilization, the contentsof the sterilizer should be removed from thechamber and left untouched for a period of30 minutes to two hours depending on theload contents.3 (PNDS: I70, I98, I122)

The potential for the formation of con-densation is decreased by allowing the con-tents of the sterilizer to remain untoucheduntil the equalization of the temperature dif-ferential between the chamber and outsideenvironment has occurred.3

III.c.1. Steam sterilizer doors should not be leftajar to cool loads following a cycle.11

Removing the sterilizer load from thesterilizer as soon as possible after steamsterilization allows the cooling processto begin earlier.

Cracking the sterilizer door may hin-der the drying process.

Wet packs may be a result of exces-sively wet steam, poor loading tech-niques, or a true sterilizer malfunction.

III.d. Warm or hot items should not be placed oncool or cold surfaces. (PNDS: I70, I98, I122)

When hot and cold surfaces are broughttogether, moisture condenses from both insideand outside the package. At the end of thesteam sterilization cycle and after an appropri-ate drying time, items still may contain somesteam vapor. Touching packages at this vulner-able stage could compromise the barrier prop-erties of the packaging material by causingmoisture and/or contaminants to wick throughthe package. Droplets inside or outside of thecontainer can form because rigid containermaterials are nonabsorbent. Condensate candrip onto surrounding containers, compromis-ing the sterility of other packages.3

III.e. Sterilized packages or containers that haveformed condensate should be consideredunsterile and none of the contents used.3

(PNDS: I70, I98, I122)Moisture can compromise the integrity of

barrier material and the sterility of the con-tents. Moisture may indicate problems withthe packaging and sterilization process.3

Recommendation IV

Use of flash sterilization should be kept to a mini-mum. Flash sterilization should be used only inselected clinical situations and in a controlledmanner.

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Table 3

TYPICAL MINIMUM CYCLE TIMES FOR GRAVITY-DISPLACEMENT STEAM STERILIZATION1

Item Exposure time at250° F (121° C)

Minimum drying time

Exposure time at270° F (132° C)

Minimum drying time

Exposure time at275° F (135° C)

Minimum drying time

Wrapped instruments

30 min 15 to 30 min 15 min 15 to 30 min 10 min 30 min

Textile packs 30 min 15 min 25 min 15 min 10 min 30 min

Wrapped utensils

30 min 15 to 30 min 15 min 15 to 30 min 10 min 30 min

Flash sterilization may be associated withincreased risk of infection to patients because ofpressure on personnel to eliminate one or moresteps in the cleaning and sterilization process.

IV.a Flash sterilization should be used onlywhen there is insufficient time to process bythe preferred wrapped or container method.Flash sterilization should not be used as asubstitute for sufficient instrument inven -tory.12 (PNDS: I70, I98)

Proper decontamination is essential inremoving bioburden and preparing an itemfor sterilization by any method. Failures ininstrument cleaning have resulted in trans-mission of infectious agents.3

IV.a.1. Items to be flash sterilized should besubjected to the same decontaminationprocesses as described in AORN’s “Rec-ommended practices for cleaning andcare of surgical instruments and pow-ered equipment.”2

IV.a.2. Flash sterilization should be performedonly if all of the following conditionsare met: • The device manufacturer’s written

instructions on cycle type, exposuretimes, temperature settings, and dry-ing times (if recommended) are avail-able and followed.

• Items are disassembled and thor-oughly cleaned with detergent andwater to remove soil, blood, body fats,and other substances.

• Lumens are brushed and flushedunder water with a cleaning solutionand rinsed thoroughly.

• Items are placed in a closed steriliza-tion container or tray, validated forflash sterilization, in a manner thatallows steam to contact all instrumentsurfaces.

• Measures are taken to prevent con-tamination during transfer to the ster-ile field.Flash-sterilized items are to be used

immediately and not stored for later use.3

Table 5 provides examples of typicalflash sterilization parameters.

IV.b. Packaging and wrapping (eg, textiles,paper/plastic pouches, nonwoven wrappers)should not be used in flash sterilization cyclesunless the sterilizer is specifically designedand labeled for this use. (PNDS: I70, I98)

Cycle parameters vary according to ster-ilizer design.

IV.b.1. Sterilizer manufacturers’ written direc-tions should be followed and recon-ciled with the packaging manufacturer’sinstructions for sterilization.3

IV.c. Process challenge devices (PCDs) should beused with routine process monitoring devices(ie, chemical indicators, biological indicators,physical monitoring devices).3 (PNDS: I70, I98)

Process challenge and process monitoringdevices provide information to demonstratethat conditions for sterilization have been met.

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Table 4

TYPICAL MINIMUM CYCLE TIMES FOR DYNAMIC AIR-REMOVAL STEAM STERILIZATION1

1. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79:2006 Comprehensive Guide toSteam Sterilization and Sterility Assurance in Health Care Facilities. Arlington, VA: Association for the Advancement ofMedical Instrumentation; 2006. Reprinted with permission.

Item Exposure time at 270° F (132° C)

Minimum drying time

Exposure time at 275° F (135° C)

Minimum drying time

Wrapped instruments 4 min 20 to 30 min 3 min 16 min

Textile packs 4 min 5 to 20 min 3 min 3 min

Wrapped utensils 4 min 20 min 3 min 16 min

IV.c.1. Each sterilization cycle should be moni-tored to verify that parameters requiredfor sterilization have been met.3

IV.c.2. The sterilizer operator should use physi-cal monitoring devices to verify cycleparameters for each load.3

Physical monitoring devices (eg,printouts, graphs, gauges) can indicateimmediate sterilizer failure. Physicalmonitors record cycle parameters (ie,time, temperature) for each cycle.

IV.c.3. Biological (BI) and chemical indicatorsshould be used to monitor sterilizer effi-cacy and assess compliance of monitor-ing standards established for gravity-dis-placement and dynamic air-removalsterilizers. Class 5 chemical integrating

indicators should be used within eachsterilizer container or tray.3

IV.d. Users should adhere to aseptic technique forflash-sterilized items during transport to thepoint of use. It is important that sterilizationprocessing be carried out in a clean environ-ment and that flash-sterilized devices aretransferred to the point of use in a mannerthat prevents contamination.

IV.e. Rigid sterilization containers designed andintended for flash-sterilization cycles shouldbe used. (PNDS: I70, I98)

Rigid flash-sterilization containers • reduce the risk of contamination dur-

ing transport to the point of use,• facilitate ease of presentation to the

sterile field, and• protect sterilized items during transport.3

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Table 5

EXAMPLES OF TYPICAL FLASH STEAM STERILIZATION PARAMETERS1

Type of sterilizer Load configuration Time Exposure Temperature Drying Times

Gravitydisplacement

Metal or nonporous itemsonly (ie, no lumens)

3 minutes 270° F–275° F (132° C–135° C)

0 to 1 minutes

Metal items with lumensand porous items (eg, rub-ber, plastic) sterilizedtogether. Complex devices(eg, powered instrumentsrequiring extended expo-sure times). Manufacturerinstructions should beconsulted.

10 minutes 270° F–275° F (132° C–135° C)

0 to 1 minute

Dynamic air-removal(prevacuum)

Metal or nonporous itemsonly (ie, no lumens)

3 minutes 270° F–275° F (132° C–135° C)

N/A

Metal items with lumensand porous items sterilizedtogether

4 minutes 3 minutes

270° F (132° C) 275° F (135° C)

N/AN/A

• The sterilizer manufacturer’s instructions for use of express cycles should be followed. One sterilizer manufacturerprovides an express flash cycle that permits flash sterilization with a single-ply wrapper to help contain the device tothe point of use. This cycle is not recommended for devices with lumens. Express cycles should only be used if thesterilizer is designed with this feature.

• Steam-flush pressure-pulse: See manufacturers’ written instructions for time and temperature.• This table does not include specific instructions for rigid flash sterilization containers. The container manufacturer’s

instructions should be followed.REFERENCE

1. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79:2006 Comprehensive Guide toSteam Sterilization and Sterility Assurance in Health Care Facilities. Arlington, VA: Association for the Advancement ofMedical Instrumentation; 2006:60-72. Adapted with permission.

IV.f. Flash-sterilization containers should beused, cleaned, and maintained according tothe manufacturer’s written instructions.3

IV.f.1. Flash-sterilization containers should beopened, used immediately, and notstored for later use.

IV.f.2. Flash-sterilization containers should be dif-ferentiated from other types of containers.

IV.g. Flash sterilization should not be used forimplantable devices except in cases ofemergency when no other option is avail-able.12 (PNDS: I85, I138)

Implants are foreign bodies and theyincrease the risk of surgical site infection.12

Careful planning, appropriate packaging,and inventory management in cooperationwith suppliers can minimize the need toflash sterilize implantable medical devices.

IV.h. In an emergency, when flash sterilization ofan implant is unavoidable, a rapid-action BIwith a Class 5 chemical integrating indica-tor (or enzyme only indicator) should be runwith the load.3,12 (PNDS: I70, I98)

IV.h.1. The implant should be quarantined onthe back table and should not bereleased until the rapid-action BI pro-vides a negative result.

IV.h.2. If the implant is used before the BIresults are known and the BI is laterdetermined to have a positive result, thesurgeon and infection prevention andcontrol personnel should be notified assoon as the results are known.

IV.h.3. If the implant is not used, it cannot besaved as sterile for future use. Resteril-ization of the device is required if theimplant is to be used later.3,12

IV.i. Documentation of cycle information andmonitoring results should be maintained ina log (electronic or manual) to providetracking of the flashed item(s) to the individ-ual patient.3,12 (PNDS: I112)

Documentation allows every load of ster-ilized items used on patients to be traced.

IV.i.1. Sterilization records should includeinformation on each load, including

• the item(s) processed; • the patient receiving the item(s); • the cycle parameters used (eg, tem-

perature, duration of cycle);• the date and time the cycle is run;• the operator information; and • the reason for flash sterilization.3

Recommendation V

Ethylene oxide (EO) sterilization is a low-tempera-ture process that is appropriate for heat- andmoisture-sensitive surgical items when indicatedby the device manufacturer.

Ethylene oxide at sterilizing temperatures killsmicrobes in hard-to-reach areas, and it does sowith no damage to devices. Ethylene oxide is analkylating agent that results in microbial deathunder controlled parameters. Ethylene oxide substi-tutes for hydrogen atoms on molecules needed tosustain life and, by attaching to these molecules,EO stops these molecules’ normal life-supportingfunctions. Some of the key molecules that EO dis-rupts are proteins and DNA. Under low-tempera-ture sterilizing conditions, so much EO is used thatthis disruption proves lethal to microbial life.13

V.a. Ethylene oxide should be used if alternatemethods of sterilization are not availablecompatible with the medical devices beingprocessed.14

Health care organizations use 100% con-centrations of EO or EO in mixtures with inertdiluent gases (eg, carbon dioxide, hydrochloro-fluorocarbons [HCFC]) for EO sterilization pro-cedures. Until the 1990s, chlorofluorocarbons(CFCs) were used as diluents for EO. Chloroflu-orocarbons cause depletion of the ozone layerand are no longer produced in the UnitedStates. Hydrochlorofluorocarbons deplete theozone layer, but to a lesser degree than CFCs.14

V.a.1. Users of HCFCs should be aware of andcomply with federal, state, and localregulations regarding HCFC use in EOsterilizers.15-17

V.b. The manufacturer’s written instructionsshould be reviewed to determine if a heat-or moisture-sensitive item is compatiblewith EO sterilization before attempting ster-ilization by this method. (PNDS: I122)

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V.c. Items, including all lumens, should be cleanand dry before being packaged for EO steril-ization. (PNDS: I75, I98, I122)

Soil inhibits sterilization, and moisturemay produce toxic by-products. The combi-nation of water and EO results in the forma-tion of ethylene glycol (ie, antifreeze).

V.d. Sterilizer manufacturers’ written instructionsshould be followed for EO sterilizationparameters and placement of items withinthe sterilizer. (PNDS: I70, I75, I122)

Ethylene oxide sterilizers differ in designand operating characteristics.

V.d.1. Items should be placed in EO sterilizersin baskets or on loading carts in a man-ner that allows free circulation and pen-etration of the EO.15

V.e. Physical monitors of EO sterilizers shouldrecord the essential parameters for steriliza-tion including temperature, exposure time,pressure.15 (PNDS: I75, I98, I122, I138)

Physical monitors provide real-timeassessment and documentation of steriliza-tion cycle parameters. Timely review ofgraphs, charts, and printouts enhance detec-tion of sterilizer malfunctions and allows forimplementation of corrective actions.3

V.f. Items sterilized in EO sterilizers should beproperly aerated in a mechanical aerator toremove EO. (PNDS: I75, I122)

Ethylene oxide residual absorbed into ster-ilized items represents a hazard to patientsand personnel, if not removed. Ethylene oxideis a known human carcinogen and a chemi-cal that has the potential to cause adversereproductive effects in humans. The Occupa-tional Safety and Health Administration(OSHA) has established exposure limits forEO in the workplace.16,18

Items not sufficiently aerated may causepatient or personnel injury (eg, chemicalburns). Aeration is the only safe and effec-tive way to remove EO.15,16,19

Adequate aeration times reduce EO vaporsand residue to a level safe for exposure ofboth patients and health care personnel.

Rinsing an inadequately aerated itemdoes not remove EO and can create haz-ardous by-products.

V.f.1. Sterilized items should be handled aslittle as possible before aeration to pre-vent health care personnel from breath-ing EO gas or coming in contact withEO residues.• Health care personnel should wear

butyl rubber, nitrile, or neoprenegloves that provide protection to theskin when handling unaerated EO-sterilized items.15

• Pulling, rather than pushing, sterilizercarts during transfer to aerators directsthe flow of EO vapors and residuesaway from health care personnel.

• When using a separate mechanicalaerator, health care personnel shouldbe protected from EO vapors andresidue during transfer of sterilizeditems from the sterilizer to the aerator.

• The transfer of products from a steril-izer to an aerator should be per-formed in as short a time as possible.

V.f.2. Required aeration times depend onmany variables that include, but are notlimited to,• item composition and size,• item preparation and packaging,• density of the load,• type of EO sterilizer used,• type of aerator used, and• temperature penetration pattern of

the aerator’s chamber.15

V.f.3. All EO-sterilized items must be completelyaerated before they can be used safely. • Aeration cycles should never be

interrupted to remove items for use.• Items should remain in aerators until

the aeration time has been completed.• Aeration requirements for the most dif-

ficult-to-aerate products may requireincreased time frames. Ethylene oxidevapors and residues diffuse from steril-ized items over time. This aeration orde gassing process can be expedited byraising the temperature and by increas-ing the flow of air around the item.

• Whenever possible, EO-sterilizeditems should be processed in sterilizersthat have an integrated aeration cycle.

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V.f.4. The device manufacturers’ writteninstructions should be followed for spe-cific aeration requirements.

V.f.5. All aeration cycle parameters should bedocumented and verified as to theaccuracy of the correct aeration timeand temperature.

V.f.6. A program for monitoring occupationalexposure to EO must be establishedaccording to OSHA regulations to accu-rately determine the permissible air-borne concentrations of EO within thehealth care setting.

Compliance with regulations pro-motes a safe work environment that is within federal and state mandatedlimits.18,20

V.g. Personnel who have the potential for exposure should wear EO-monitoringbadges that meet the National Institute forOccupational Safety and Health standardsfor accuracy.15,21,22

V.g.1. The EO-monitoring program in eachorganization must comply with OSHAregulations.16

General environmental monitoring isnot required, although it may providean indicator of problems with the venti-lation or EO system.15

Monitoring of short term exposuresover a 15-minute period also is requiredwhile sterilizer and aeration activitiesare being performed.

V.h. Health and safety procedures should bedeveloped for health care personnel.

Established procedures help to identify,eliminate, or minimize risk from exposure tohazards as well as facilitate timely responseto accidental exposure and emergencies.

V.h.1. Personnel should be informed about thehealth effects and potential hazardsassociated with exposure to EO.

V.h.2. Information on the EO health effectsand potential hazards should be pro-vided at the time of assignment to anarea where EO is used and at leastannually thereafter.

V.h.3. Periodic employee and environmentalphysical assessment and testing shouldbe carried out and documented accord-ing to current OSHA regulations.15,21,23

V.h.4. Personnel should be familiar with theorganization’s emergency spill plan.18

V.h.5. Personnel should be aware of safetyprocedures that should be implementedfollowing exposure to EO.

People who have inhaled concen-trated EO gas • should seek fresh air immediately; • may require the administration of

oxygen; and • may require cardiopulmonary resus-

citation, if respiratory or cardiac col-lapse occurs.15,19

The material safety data sheet (MSDS)for the type of ethylene oxide usedshould be consulted for specific first-aidmeasures after exposure.

V.i. Documentation of employee breathing zoneEO monitoring must be maintained inemployees’ health records for the durationof employment plus 30 years after termina-tion of employment.15,23

Documentation establishes a continuoushistory of the work environment.

Recommendation VI

Low-temperature hydrogen peroxide gas plasmasterilization methods should be used for moisture-sensitive and heat-sensitive items and when indi-cated by the device manufacturer.

Low-temperature hydrogen peroxide gas plasmasterilization uses a combination of hydrogen perox-ide vapor and low-temperature hydrogen peroxidegas plasma.24 In this process, microbial life is dis-rupted when free radicals created from hydrogenperoxide gas plasma interact with microbial cellmembranes, enzymes, or nucleic acids.16

Items processed using a low-temperature hydro-gen peroxide gas plasma sterilization require noaeration because the residuals and by-products areoxygen and water in the form of humidity.16,25,26

Items are dry at the end of the cycle. Hydrogen peroxide is a severe irritant, but it is

considered nonmutagenic and noncarcinogenic.16,24,27

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VI.a. The sterilizer manufacturer’s written instruc-tions for use, monitoring, and maintenanceshould be followed when using a low-tem-perature hydrogen peroxide gas plasma ster-ilization system. (PNDS: I75, I98, I122)

VI.a.1. Written documentation of the accept-ability of low-temperature hydrogenperoxide gas plasma sterilization forspecific devices should be obtainedfrom the instrument manufacturer.

VI.a.2. Devices with lumens should complywith the sterilizer manufacturer’s lumenspecifications relating to diameter andlength of the device.26,27,28

VI.b. Items to be gas-plasma sterilized shouldclean and dry and packaged in nonwovenpolypropylene wraps, high-density polyeth-ylene, or biaxially oriented polyethyleneterephthalate polyester film (ie, Mylar)pouches.

Cellulose-based (eg, paper-based) pack-aging materials or products and liquids arenot suitable for low-temperature hydrogenperoxide gas plasma sterilization.

VI.c. Trays designed and validated for use withlow-temperature hydrogen peroxide gasplasma sterilization should be used.

VI.d. When loading a low-temperature hydrogenperoxide gas plasma sterilizer, the load con-figuration and placement of items inside thesterilizers should comply with the sterilizermanufacturer’s recommendations. (PNDS:I122)

Proper load configuration allows sterilantcontact.3

Recommendation VII

Sterilization systems using peracetic acid as a low-temperature liquid sterilant is appropriate forheat-sensitive surgical items that can be immersedand when indicated by the device manufacturer.

Peracetic acid sterilization is a system that usesa chemical formulation of 35% peracetic acid andwater. Peracetic acid is an oxidizing agent that isan effective biocide at low temperatures and iseffective in the presence of organic matter. It has a

chemical formula of acetic acid plus an extra oxy-gen atom. This extra oxygen atom is highly reac-tive, reacts with most cellular components, andcauses cellular death. The ability of peracetic acidto inactivate many different critical cell systems isresponsible for its broad spectrum antimicrobialactivity. As peracetic acid returns to acetic acid (ie,vinegar) and the oxygen decomposes, it is ren-dered nontoxic and environmentally safe.

VII.a. Items sterilized by liquid peracetic acid ster-ilization should be used immediately. Thissterilization technique should not be usedfor items to be stored for later use withoutadditional processing. (PNDS: I70, I75, I98:I122)

VII.b. Sterilization systems using liquid peraceticacid should be used, monitored, and main-tained according to the manufacturer’s writ-ten instructions. (PNDS: I70, I98, I122)

Peracetic acid is an effective sterilizingagent that does not leave toxic residues onsterilized items when items are rinsed prop-erly. Serious injuries (eg, burns) may result ifthe chemical is not handled, neutralized,and rinsed properly. Peracetic acid is corro-sive to the skin at concentrations of 3.4% orhigher and corrosive to eyes at concentra-tions of 0.35% or higher.26-29

VII.c. Health care personnel should clean andprocess endoscopes and their accessoriesaccording to AORN’s “Recommended prac-tices for cleaning and processing endo-scopes and endoscope accessories,”30 andthe manufacturer’s specific instructionswhen using peracetic acid, as with othersterilization/disinfection processes. (PNDS:I75, I98, I122)

Peracetic acid is an efficient, effectivemethod for cleaning and disinfecting endo-scopes and accessories with lumens inorder to provide high-quality patient care,ensure equipment integrity, and facilitaterapid turn around on endoscopes and otheritems that need to be used quickly.26,29

VII.d. When using peracetic acid to sterilize itemswith lumens, health care personnel shouldverify proper selection of adapters and con-nect the device to the appropriate adapters

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as recommended by the manufacturer ofboth the device and sterilizer. (PNDS: I70,I75, I98, I122)

Failure to do so may result in failure tosterilize the lumen of the item.

VII.e. Items sterilized in an automated systemusing peracetic acid should be transportedto the point of use and used immediately.(PNDS: I70, I98, I122)

Items sterilized with peracetic acid arewet and the cassette or container in whichthey are sterilized is not sealed to preventcontamination, thereby increasing the riskof contamination if not used immediately.

VII.f. The ability to successfully process devicesintended for use with a peracetic acid systemshould be validated by the device manufac-turer and comply with the sterilizer manufac-turer’s written instructions. (PNDS: I122)

Exposure and cycle times are importantfactors in assessing the efficiencies of adecontamination or sterilization process.

VII.f.1. Appropriate use of sterilizers should beidentified to ensure proper sterilizationand prolong the life of instrumentation.

VII.f.2. Documentation of items that can andcannot be processed in peracetic acidshould be obtained from the device andsterilizer manufacturers.

Peracetic acid can be corrosive tosome items not meant for this type ofprocessing.

Recommendation VIII

Sterilization systems using ozone should be usedfor moisture and heat-sensitive items when indi-cated by the device manufacturer.

Ozone is a strong oxidizer, which makes ozonesterilization an effective low-temperature steriliza-tion process. Ozone is generated within the steril-izer using only oxygen and water. On completionof the sterilization cycle, ozone is exhaustedthrough a catalytic converter, where it is convertedback into the raw materials of oxygen and water.No aeration of sterilized items is necessarybecause these by-products are nontoxic.16,28;29,31

VIII.a. Manufacturers’ written instruction for oper-ating, monitoring, and maintaining ozonesterilizers should be followed. (PNDS: I122)

Ozone has been cleared by the US Foodand Drug Administration (FDA) for use inthe sterilization of metal and plastic surgicalinstruments, including some instrumentswith lumens.

VIII.a.1. All devices should comply with the ster-ilizer manufacturer’s specifications forlumen length and diameter.

VIII.b. Items to be processed in ozone should bepackaged in nonwoven pouches or reusablerigid sterilization containers validated by thecontainer manufacturer for use in ozone ster-ilizers.28,31 (PNDS: I70, I98, I122)

Cellulose-based packaging materials andproducts are not suitable for ozone steriliza-tion processes.

Recommendation IX

Dry-heat sterilization should be used to sterilizeanhydrous (ie, waterless) items that can withstandhigh temperatures and when indicated by thedevice manufacturer.

Sharp instruments that would be damaged by themoisture of steam may be sterilized by dry-heat.9

Dental instruments, burrs, reusable needles, glass-ware, and heat-stable powders and oils are exam-ples of items that can withstand the high tempera-tures generated by dry-heat sterilization. Dry heat isan oxidation or slow burning process that coagulatesprotein in microbial cells. There is no moisture pres-ent in a dry-heat process, so microorganisms aredestroyed by a very slow process of heat absorption.

IX.a. Dry-heat sterilizers should be used, moni-tored, and maintained according to the man-ufacturer’s written instructions. (PNDS: I122)

Dry heat sterilizers may vary in designand performance characteristics.

IX.b. Only packaging and container materialsdesigned to withstand the high temperatureof the dry-heat sterilization should be usedfor this type of processing. (PNDS: I122)

If packaging is not formulated for dry-heatsterilization, pouches may char, compromising

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the aseptic presentation and storage of ster-ilized items.

IX.b.1. Closed containers or cassettes mayextend the time needed to achieve ster-ilization; therefore, the use of such con-tainers should be based on manufactur-ers’ instructions and biological indicatormonitoring results.

IX.b.2. Manufacturers should be consulted toconfirm the compatibility of the packag-ing material with sterilizer temperaturesbefore packaging materials are selectedfor dry-heat sterilization.32

IX.b.3. When possible, small containers shouldbe used for items to be dry-heat steril-ized, and package density should be aslow as possible.32

Most types of tape are not designedto withstand the high dry-heat steriliza-tion temperatures. Tape adhesive meltswhen subjected to dry-heat sterilizationand may leave a sticky residue on steril-ized packages that degrades, leavingbaked-on tape residue on the items, orcan result in loss of tape adhesion.32

IX.c. The operator should be aware of the hazardsassociated with dry-heat sterilization and usethe appropriate protective equipment (eg, insu-lated gloves, transfer handles).32 (PNDS: I122)

Burns are the most common safety haz-ard associated with dry-heat sterilization.

IX.c.1. On completion of the sterilizationcycle, both the sterilizer chamber andthe items in the chamber are very hotand should not be touched.

IX.c.2. Packages should be cooled before beinghandled or removed from the dry-heatsterilizer.

IX.d. Presterilized oils and powders are commer-cially available and should be consideredbefore purchasing a dry-heat sterilizer.

Dry-heat sterilizers are not commonlyavailable in operating rooms or sterile pro-cessing departments.

When used, the main purpose of a dry-heat sterilizer is to sterilize talcum powderfor surgical procedures.

Recommendation X

A formalized program between health care organ-izations and health care industry representativesshould be established for the receipt and use ofloaner instrumentation.

Implementation of tracking and quality controlsand procedures are necessary to manage instru-mentation and implants brought in from outsideorganizations and companies.33

X.a. Interdisciplinary collaboration between thehealth care organizations’ sterile processing,operative services and commercial healthcare industry representatives should beestablished.

The systematic management of loanerinstrumentation reduces loss and ensuresproper decontamination and sterilizationthrough increased communication andaccountability.

X.a.1. The loaner instrumentation processshould include, but not be limited to,• requesting loaner instrumentation or

implant; (PNDS: I85)• receiving loaner items, including a

detailed inventory list; (PNDS: I85)• obtaining manufacturers’ written

instruction for instrument care,cleaning, assembly, and sterilization;(PNDS: I122)

• cleaning, decontaminating, and ster-ilizing borrowed instrumentation bythe receiving facility, performed inaccordance with AORN’s “Recom-mended practices for cleaning andcare of surgical instruments andpowered equipment;”2 (PNDS: I70,I98, I138)

• transporting processed loaner instru-mentation to the point of use;(PNDS: I98)

• returning items to the sterile process-ing department following the proce-dure for decontamination, process-ing, inventory, and return to thehealth care industry representative;(PNDS: I98) and

• maintaining historical records oftransactions.

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X.b. Personnel should coordinate requests forloaner instrumentation in sufficient time forloaner items to be processed by conven-tional sterilization methods. (PNDS: I138)

Advance delivery of loaner items to thereceiving health care organization ensuressufficient time to permit in-house disassem-bly, cleaning, packaging, quality assurancetesting, and sterilization of the instrumentsbefore scheduled procedures.

X.b.1. Personnel requesting loaner itemsshould specify quantities, estimatedtime of use and return, and restockingrequirements to circumvent the need forflash sterilization.

X.b.2. Flash sterilization should not be used asa substitute for sufficient instrumentinventory resulting from late delivery ofloaner instrumentation.

X.c. Loaner instrumentation sterility assuranceshould begin on receipt at the point wherethe health care organization personnelassume responsibility for the items.3

Failures in instrument cleaning haveresulted in transmission of infectious agents

X.c.1. All loaner instruments should be consid-ered contaminated and delivered directlyto the decontamination area for process-ing. Instruments should be thoroughlycleaned and dried in a manner consis-tent with AORN’s “Recommended prac-tices for cleaning and care of surgicalinstruments and powered equipment”2

and the standards of the Association forthe Advancement of Medical Instrumen-tation before sterilization.3,15 (PNDS: I70,I98, I122, I138)

X.c.2. Newly manufactured loaner itemsshould be properly decontaminatedbefore sterilization to remove biobur-den and substances (eg, oils, greases)remaining on the item during the manu-facturing process.3

X.c.3. Clean or sterile items transported tosterile processing should be removedfrom external shipping containers.3

External shipping containers mayhave potentially high microbial contam-ination due to environmental exposuresduring transport.

X.c.4. Rigid sterilization containers should bethoroughly inspected on receipt andcleaned and decontaminated accordingto manufacturers’ instructions.

Containers should be inspected forintegrity and function.

X.c.5. Loaner items, type, and quantity shouldbe inventoried and documented.

X.c.6. Implants and instruments should bevisually inspected for damage.

X.c.7. Manufacturers’ instructions on process-ing and sterilizing loaner items shouldbe followed.

X.c.8. Loaner items should be decontaminatedand handled in accordance with organi-zational policy following the procedure.

X.c.9. Implantable devices should be sterilizedwith a BI and a Class 5 integrating indi-cator and documented in accordancewith FDA regulations and AORN rec-ommended practices.

Recommendation XI

Sterilized materials should be packaged, labeled,and stored in a manner to ensure sterility, and eachitem should be marked with the sterilization date.3,34

Limiting exposure to moisture, dust, excessivelight or handling, and temperature and humidityextremes decreases potential contamination of ster-ilized items.3

XI.a. The shelf life of a packaged sterile itemshould be considered event-related. (PNDS:I70, I98, I122)

An event must occur to compromisepackage content sterility. Events that maycompromise the sterility of a packageinclude, but are not limited to,– multiple handling that leads to seal

breakage or loss of package integrity,– moisture penetration, and– exposure to airborne contaminants.3,15,32

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NOTE: Ambulatory surgery centers should referto the Centers for Medicare and Medicaid Serv-ices State Operations Manual for AmbulatoryServices that states, “Sterilized materials shouldbe packaged, labeled, and stored in a mannerto ensure sterility and that each item is markedwith the expiration date.”35

XI.b. Sterile packages should be stored underenvironmentally controlled conditions.2

(PNDS: I70, I98, I122)Controlled conditions reduce the risk of

contamination.

XI.b.1 The temperature in the sterile storageareas should not exceed 24° C (75° F).

XI.b.2. The storage area should have at leastfour air exchanges per hour.

XI.b.3. Relative humidity should be controlled,not to exceed 70%.

XI.b.4. Traffic should be controlled to limitaccess to those trained in handling ster-ile supplies. (PNDS: I81)

XI.b.5. Supplies should be stored in a mannerthat allows adequate air circulation,ease of cleaning, and compliance withlocal fire codes. (PNDS: I98)

XI.b.6. Sterile items should be stored at leasteight to 10 inches above the floor, at least18 inches below sprinkler heads, and atleast two inches from outside walls.

XI.b.7. Outside shipping containers should notbe allowed in the sterile storage areabecause they serve as generators of, andreservoirs for, dust. (PNDS: I98)

XI.c. Storage conditions should be evaluatedbefore policies and procedures on event-related sterility are written for perioperativepractice settings. (PNDS: I70, I98, I122, I138)

The shelf life of packaged sterile items isevent-related and dependent on packagingmaterial, storage conditions, transport andhandling. Adequacy and quality of storagespace are factors to be considered whenwriting policies and procedures.3

XI.c.1. All storage items should be rotated accord-ing to the principle of “first in, first out.”

Recommendation XII

Transportation of sterile items should be controlled.

Sterility is event-related and depends on theamount of handling, conditions during transporta-tion and storage, and the quality of the packagingmaterial.

XII.a. Sterile items should be transported in cov-ered or enclosed carts with solid-bottomshelves. (PNDS: I70, I81, I98, I122)

Covered or enclosed carts will protectsterile items from exposure to environmen-tal contaminants during transportation.

XII.a.1. Carts and reusable covers should becleaned after each use because contam-inants are picked up from the environ-ment during transport.3

XII.b. Written policies and procedures shouldaddress prevention of physical damage andmaintenance of package sterility duringtransport.

Procedures for transporting sterile itemscan help preserve the quality of sterile pack-ages and maintain the integrity of processeditems until the time of use.3,15

XII.b.1. Transportation conditions should be eval-uated before policies and procedures forthe transportation of sterile items are writ-ten for perioperative practice settings.3,15,32

(PNDS: I70, I81, I98, I122, I138)

Recommendation XIII

CompetencyAn introduction and review of policies and proce-dures should be included in personnel orientation tosterile processing of surgical instruments in the peri-operative setting. Continuing education should beprovided for employees when new equipment, instru-ments, and processes are introduced. (PNDS: I1)

Operator and processing errors are minimizedwith regularly scheduled education, training, andcompetency demonstration.3,15

XIII.a. Sterilization-specific education and compe-tency assessment of personnel shouldencompass all sterilization methodologiesin use in the organization, to include

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– operation and maintenance of steriliza-tion equipment;

– selection and monitoring of sterilizationcycles;

– use of chemical, biological, and physicalmonitoring measures; and

– documentation requirements.

XIII.b. Education should address, but not be lim-ited to,– orientation programs to equipment and

work area;– infection control policy and procedure,

including exposure plans;– potential hazards in the environment and

methods of hazard protection; – safe ergonomic practices; and– use and location of MSDS.

Recommendation XIV

DocumentationSterilization records should be maintained for atime specified by the health care organization’spolicies and in compliance with local, state, andfederal regulations.3,15,32

Accurate and complete records are required forprocess verification and used in sterilizer malfunc-tion analyses. Documentation establishes account-ability.

XIV.a. Every sterilization cycle and modality,including steam (eg, wrapped, unwrapped),EO, hydrogen peroxide gas plasma, liquidperacetic acid, ozone, and dry heat shouldbe documented. Documentation shouldinclude– the assigned lot number;– contents of each load; and– results of physical, chemical, and biologi-

cal monitors.

Recommendation XV

Policies and ProceduresPolicies and procedures for sterilization processesshould be developed, reviewed periodically, andreadily available in the practice setting. (PNDS: I1)

Policies and procedures establish authority,responsibility, and accountability and serve asoperational guidelines. Policies and procedures

also assist in the development of continuous qual-ity improvement activities.

XV.a. Policies and procedures for routine cleaningof sterilizer chambers, carts, and exteriorsurfaces should be developed and imple-mented. (PNDS: I122)

XV.b. These recommended practices for steriliza-tion should be used to guide the develop-ment of policies and procedures withinindividual perioperative practice settings.

XV.c. The sterilizer manufacturer’s written instruc-tions for cleaning should be reviewed andfollowed.

XV.d. An introduction and review of policies andprocedures should be included in the orien-tation and ongoing education of health carepersonnel to assist in the development ofknowledge, skills, and attitudes that affectpatient outcomes.

XV.e. User manuals for all sterilization equipmentshould be readily available to the sterilizeroperators. (PNDS: I122)

As new technologies are introduced foruse in perioperative practice settings, it isimperative that health care personnel strictlyfollow manufacturers’ written instructionsfor the operation and maintenance of sterili-zation equipment and are aware of theoccupational hazards that different sterilantsmay pose to patients, health care personnel,and the environment. Compliance with theSafe Medical Device Act of 1990, whichwas amended in 2000, is required and willcontribute to patient safety.36

XV.e.1. Equipment manuals should be retainedfor the life of the sterilizer.

XV.f. When selecting a new sterilization technol-ogy, perioperative nurses and nurse man-agers should follow AORN’s “Recom-mended practices for product selection inperioperative practice settings.”37

Capital equipment and medical deviceprocurement are collaborative processesrequiring clinical, business, financial, andlegal acumen. Goals of product standardiza-tion and value analysis processes are to selectfunctional and reliable products that are safe,

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cost-effective, and environmentally consciousand that promote quality care and avoidduplication or rapid obsolescence.

Recommendation XVI

QualityA quality control program should be establishedand maintained. (PNDS: I1)

Quality control programs that enhance person-nel performance and monitor sterilization efficacyare established to promote patient and employeesafety.

XVI.a. The health care organization should estab-lish quality control and improvement pro-grams to monitor the work place environ-ment and practices associated withcleaning, disinfection, and sterilization ofsurgical instruments.

Monitoring the sterilization processallows results to be compared to a predeter-mined level of quality. Reviewing the find-ings provide a method of identifying prob-lems and trends to change and improvepractice.

XVI.b. All sterilizer failures and corrective actionsshould be documented and reported to theinfection control professional and/or qualityassurance committee, and to administration.

XVI.c. All BI test results, including results fromcontrols, should be interpreted by qualifiedpersonnel in the time frame specified by theBI manufacturer and should be included inthe sterilization records. (PNDS: I70, I98,I122, I138)

Accurate interpretation and reporting ofpositive results promotes safe patient care.3

XVI.c.1. Positive BI test results should be reportedimmediately so that appropriate actioncan be taken. • The sterilizer printout should first be

checked to determine if the cycleparameters were met.

• If retrievable, items processed in thesuspect sterilizer (ie, back to the lastknown negative BI test) should berecalled and reprocessed before use.

3

• The positive BI vial should be sent tothe laboratory for subculturing forbacilli (the recall should not bedelayed during this testing).

• All actions taken in response to a posi-tive BI test should be documented.

• A positive control should be placedin each incubator each day a test vialis run and incubated.

XVI.c.2. All control vials should be from thesame lot number as the BI test vial forthe test to be considered valid.3

XVI.d. Processed items should be labeled with lotcontrol numbers to identify the sterilizerused, the cycle or load number, and thedate of sterilization. (PNDS: I122)

Lot control numbers allow items to beidentified or retrieved in the event of a ster-ilizer failure or malfunction.3,15,32

XVI.d.1. Information should be recorded fromeach sterilization cycle and shouldinclude, but not be limited to, • identification of sterilizer (eg, “steril-

izer #1”); • type of sterilizer and cycle used; • lot control number; load contents

(eg, major set, Kelly clamps);3

• critical parameters for the specificsterilization methodology (eg, expo-sure time, temperature for steam ster-ilization);

• operator’s name; and • results of sterilization process monitor-

ing (ie, biological, chemical, physical).

XVI.e. Physical monitors should be used to verifytime, temperature, and pressure recordingsfor steam sterilization cycles. (PNDS: I70,I98, I122)

Physical monitoring provides real-timeassessment of cycle conditions while provid-ing historical records by means of graphs,printouts, or charts. Reviewing data from phys-ical monitoring can readily identify sterilizermalfunctions to expedite corrective actions.3

XVI.e.1. Recordings of physical data should beused, when available, for all steriliza-tion methodologies to ascertain that

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sterilization systems function withinmanufacturers’ specifications.3,15

XVI.e.2. The printout should be reviewed at theend of each cycle and signed by thesterilizer operator verifying that all ster-ilization parameters were met.

XVI.f. A sterilization chemical indicator should beused inside and outside each package andload sterilized. (PNDS: I122)

The purpose of the external chemicalindicator is to differentiate betweenprocessed and unprocessed items.

Internal chemical indicators do not estab-lish whether the item is sterile, but they dodemonstrate that the contents were exposedto the sterilant.

XVI.f.1. Although external chemical indicatorsdo not verify sterility, they help detectprocedural errors and equipment mal-functions; therefore, the color changeshould be verified before opening.

XVI.f.2. An external chemical indicator shouldbe used on the outside of each packageunless the internal chemical indicator isvisible.

XVI.f.3. Chemical indicators should be reviewedfor a proper endpoint response (eg.color, migration or other change).

XVI.f.4. If the interpretation of the external orinternal process monitors suggests inade-quate processing, the item should not beused.3,15,38 (PNDS: I70, I98, I122, I138)

XVI.f.5. The internal chemical indicator shouldbe reviewed for a proper end pointresponse (eg, color, migration, otherchange) before placing the items or trayon the sterile field.

XVI.g. Quality assurance testing of rigid containersshould be performed before initial use, andperiodically, according to manufacturerswritten instructions.3 (PNDS: I122, I138)

Rigid sterilization container systems varywidely in design, mechanics, and construc-tion. These variables can affect the perform-ance of characteristics and suitability ofcontainers with sterilization methods.

XVI.g.1. The following measures should be evalu-ated when conducting periodic productquality assurance testing of sterilizationcontainers for each sterilizer type used:• sterilization efficacy, and• drying effectiveness.

Health care organizations are respon-sible for obtaining and maintaining man-ufacturers’ documentation of methodol-ogy and performance testing of thecontainer system.

Health care personnel are responsi-ble for ensuring that container systemsare suitable for proposed sterilizationuses and are compatible with existingsterilizers.

XVI.g.2. Personnel should perform product test-ing to verify and collaborate with thesterilizer manufacturer for resolution oftechnological concerns.

XVI.h. Sterilization conditions such as exposuretime should be evaluated with physical, bio-logical, and chemical monitoring by strate-gically placing monitors alongside eachother at locations that present the greatestchallenge to air evacuation and sterilantpenetration. (PNDS: I70, I122, I138)

Table 6 indicates types and applicationsof sterilization monitoring devices.

XVI.h.1. Monitors should be used for routineload release, routine sterilizer efficacymonitoring, sterilizer qualification test-ing (eg. after installation, relocation,malfunctions, major repairs, steriliza-tion process failures) and periodic prod-uct quality assurance testing for all ster-ilization processes. Table 7 providesrecommendations for sterilizer testingprocess monitoring.3,15,32,33,39

XVI.h.2. Steam sterilizers: Geobacillus stearo -thermophilus biological indicatorsshould be used for routine load release,routine sterilizer efficacy monitoring,sterilizer qualification testing, and peri-odic product quality assurance testing.

Routine sterilizer efficacy monitoringshould be done weekly, preferably daily,as follows:

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• each load containing an implantabledevice should be monitored with aBI and quarantined until the resultsof the BI testing are available, and

• one BI PCD should be run in threeconsecutive empty cycles for steril-izer qualification testing.If a steam sterilizer is intended to be

used for multiple types of cycles (eg,gravity-displacement, dynamic air-removal, flash), each sterilization modeshould be tested.3

XVI.h.3. Ethylene oxide sterilizers: Bacillus atro-pheus (formerly Bacillus subtilis) sporetesting should be performed with everyload.

XVI.h.4. Low temperature hydrogen peroxide gasplasma sterilizers: Geobacillus stearo -thermophilus biological indicators areused for routine load release, routinesterilizer efficacy monitoring, sterilizerqualification testing and periodic prod-uct quality assurance testing.28

Routine sterilizer efficacy monitoringshould be done weekly, preferablydaily, as follows:• each load containing an implantable

device should be monitored with aBI and quarantined until the resultsof the BI testing are available,

• one BI PCD should be run in threeconsecutive empty cycles for steril-izer qualification testing, and

• the sterilizer manufacturer should beconsulted for the specific monitoringproduct(s) to use and the appropriateplacement of the product within thesterilizer.

XVI.h.5. Ozone sterilizers: Geobacillus stearo -thermo philus biological indicators areused for routine load release, routine ster-ilizer efficacy monitoring, sterilizer quali-fication testing and periodic productquality assurance testing.28

Routine sterilizer efficacy monitoringshould be done weekly, preferablydaily, as follows:

• each load containing an implantabledevice should be monitored with aBI and quarantined until the resultsof the BI testing are available,

• one BI PCD should be run in threeconsecutive empty cycles for steril-izer qualification testing, and

• the sterilizer manufacturer should beconsulted for the specific monitoringproduct(s) to use and the appropriateplacement of the product within thesterilizer.

XVI.h.6. Liquid peracetic acid sterilizers: Geo -bacillus stearothermophilus biologicalindicators should be performed daily forroutine sterilizer efficacy monitoring.• The test product used should be

designed specifically for use with liq-uid peracetic acid processes.

• The sterilizer manufacturer’s writteninstructions for use should be followed.

XVI.h.7. Dry-heat sterilizers: Bacillus atropheusbiological indicators should be used forroutine load release, routine sterilizerefficacy monitoring, sterilizer qualifica-tion testing and periodic product qualityassurance testing.

Routine sterilizer efficacy monitoringshould be done weekly, preferablydaily, as follows:• each load containing an implantable

device should be monitored with aBI and quarantined until the resultsof the BI testing are available;

• sterilizer qualification testing one BIPCD should be run in three consecu-tive empty cycles;

• mechanical convection (ie, forced air)dry-heat sterilizers should be moni-tored according to the manufacturer’srecommendations, additional moni-toring of three consecutive steriliza-tion cycles should be performed afterinstallation, major repair, redesign, orrelocation of sterilizers; and

• this testing is performed in an other-wise empty sterilizer.

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1. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79:2006—Comprehensive Guide to Steam Sterilizationand Sterility Assurance in Health Care Facilities. Arlington, VA: Association for the Advancement of Medical Instrumentation; 2006.

2. Association for the Advancement of Medical Instrumentation. ANSI/AAMI/ISO 11140-1: Sterilization of health care products—Chemicalindicators, Part 1: General requirements. Arlington, VA: Association for the Advancement of Medical Instrumentation; 2005.

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Monitor Frequency of Use Application(release of sterilizer, package, load)

Physical MonitorsTime, temperature, and pressure recorder dis-plays; digital printouts; and gauges

Should be used for every load of every sterilizer. Part of load release criteria.

Chemical Indicators (CIs)External CIs Class I (process indicators) Should be used on outside of every package. Part of load and package release criteria.

Bowie-Dick-type indicatorsClass 2 (Bowie-Dick)

For routine sterilizer testing (dynamic air-removal sterilizers only): Should be run within atest pack each day in an empty sterilizer beforethe first processed load.

Test of sterilizer efficacy of air removal andsteam penetration; part of release criteria forusing sterilizer for the day.

For sterilizer qualification testing (dynamic-air-removal sterilizers only): Should be run within atest pack after sterilizer installation, relocation,malfunction; after major repairs; and after sterili-zation process failures. Test should be run threetimes consecutively in an empty chamber afterbiological indicator (BI) tests.

Part of release criteria for placing sterilizerinto service after qualification testing.

Internal CIs Should be used inside each package. Part of package release criteria at use site.

Should be used in periodic product qualityassurance testing.

Part of release criteria for changes made to routinely sterilized items, load configuration,and/or packaging. Release criteria shouldinclude BI results.

Class 3 (single-variable indicator)Class 4 (multi-variable indicator)2

May be used to meet internal CI recommen-dation.

Part of package release criteria at use site;NOT to be used for release of loads.

Class 5 (integrating indicator)Enzyme-only indicator

• May be used to meet internal CI recom-mendation.

• Within a process challenge device (PCD),may be used to monitor nonimplant steril-izer loads .

• Within a PCD, should be used to monitoreach sterilizer load containing implants. ThePCD should also contain a BI.

• Part of package release criteria at use site.• Part of load release criteria for nonimplant

loads.

• Part of release criteria for loads containingimplants. Except in emergencies, implantsshould be quarantined until BI results areknown.

Biological Indicators • Within a PCD, may be used to monitornonimplant loads.

• Within a PCD should be used in every loadcontaining implants. The PCD should alsocontain a Class 5 integrating indicator oran enzyme-only indicator.

• Within a PCD, should be used for weekly,preferably daily (ie, each day the sterilizeris used), routine sterilizer efficacy testing,(The PCD may also contain a CI). Shouldbe run in a full load for wrapped items; fortable-top sterilization, should be run in afully loaded chamber; for flash sterilization,should be run in an empty chamber.

• Within a PCD should be used for sterilizerqualification testing (after sterilizer installa-tion, relocation, malfunction, major repairs,sterilization process failures). The PCD mayalso contain a CI.

• Test should be run three times consecutivelyin an empty chamber except for table-topsterilizers, where the test should be run threetimes consecutively in a full load.

• Should be used for periodic product qual-ity assurance testing.

• Part of load release criteria.

• Part of release criteria for loads containingimplants. Except in emergencies, implantsshould be quarantined until Bi results areknown.

• Part of sterilizer/load release and recall criteria.

• Part of release criteria for placing sterilizerinto service after qualification testing.

• Part of release criteria for changes made toroutinely sterilized items, load configuration,and/or packaging.

Table 6

TYPES AND APPLICATIONS FOR USE OF STERILIZATION MONITORING DEVICES1,2

RP: Sterilization


Routine load release Routine sterilizerefficacy monitoring

Sterilizer qualifica-tion testing

(after installation, relo-cation, malfunctions,major repairs, sterili-

zation process failures)

Periodic productquality assurance

testing

Nonimplants Implants

Physical monitoringof cycle.

External and inter-nal chemical indi-cator monitoring ofpackages.

Optional monitor-ing of the load witha process challengedevice (PCD) con-taining one of thefollowing:• a biological indi-

cator (BI),• a BI and a Class

5 integratingindicator,

• a BI and anenzyme-onlyindicator

• a Class 5 inte-grating indicator,

• an enzyme-onlyindicator.


External and inter-nal chemical indica-tor monitoring ofpackages.

Monitoring of everyload with a PCDcontaining a BI anda Class 5 integratingindicator or a PCDcontaining a BI andan enzyme-onlyindicator.



Weekly, preferablydaily (or each daythe sterilizer isused), monitoring ofa full load with aPCD containing a BI(The PCD may alsocontain a chemicalindicator [CI]). Inflash sterilizationcycles, monitoring isdone in an emptychamber.

For dynamic air-removal sterilizers,daily Bowie-Dicktesting in an emptychamber



For sterilizers largerthan 2 cubic feetand for flash sterili-zation cycles, moni-toring of three con-secutive cycles in anempty chamber witha PCD containing aBI. (The PCD mayalso contain a CI.)

For table-top steriliz-ers, monitoring ofthree consecutivecycles in a fullyloaded chamber witha PCD containing aBI. (The PCD mayalso contain a CI.)

For dynamic air-removal sterilizers,monitoring of threeconsecutive cyclesin a empty chamberwith a Bowie-Dicktest pack.


Placement of BIsand CIs within prod-uct test samples.

Table 7STERILIZATION PROCESS MONITORING RECOMMENDATIONS1

REFERENCE1. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79:2006—Comprehensive Guide to

Steam Sterilization and Sterility Assurance in Health Care Facilities. Arlington, VA: Association for the Advancement ofMedical Instrumentation; 2006. Adapted with permission.

XVI.h.8. Dynamic air-removal steam sterilizers:A Bowie-Dick air removal test shouldroutinely be performed daily in anempty chamber.• The air-removal test is designed to

detect residual air in the sterilizerchamber.

• The test should be run in accordancewith the test manufacturer’s instruc-tions before the routine biologicalindicator testing.Whenever a dynamic air-removal

sterilizer is installed, relocated, mal-functions, undergoes a major repair, orhas a sterilization process failure, threeconsecutive cycles in an empty cham-ber should be tested with a BI PCD fol-lowed by three consecutive cycles in anempty chamber with a Bowie-Dick test.

XVI.i. Preventive maintenance on sterilizersshould be performed by qualified personnelon a scheduled basis. (PNDS I122)

Periodic inspections, maintenance, andreplacement of components subject to wear(eg, recording devices, steam traps, filters,valves, drain pipes, gaskets) help maintainproper functioning of sterilizers.

XVI.i.1. Inspection and cleaning should be per-formed as outlined in the manufac-turer’s written instructions.3,10,15

Proper inspection and cleaning mini-mizes sterilizer downtime and helpsprevent sterilizer malfunctions.

XVI.i.2. Preventive maintenance and repairsshould be performed by qualified per-sonnel as specified in the manufac-turer’s written instructions.

XVI.i.3. Maintenance records should be kept foreach sterilizer. Accurate and completerecords are required for sterilizationprocess verification. Information shouldinclude, but not be limited to,• date of service; • sterilizer model and serial number; • sterilizer location; • description of malfunctions; • name of person and company per-

forming maintenance;

• description of service and partsreplaced;

• results of biological indicator testing,if performed;

• results of Bowie-Dick testing, if per-formed;

• where appropriate, the name of theperson requesting the service; and

• the signature and title of the personacknowledging the completed work.

Glossary

Aeration: Method by which absorbed ethyleneoxide (EO) is removed from EO-sterilized items bycirculating warm air in an enclosed cabinet specifi-cally designed for this purpose.

Anhydrous: Items that are free of water.Bioburden: The degree of microbial load; the

number of viable organisms contaminating an object. Biofilm: A thin coating containing biologically

active organisms that have the ability to grow inwater, water solutions, or in vivo and that coat thesurface of structures (eg, teeth, inner surfaces ofcatheters, tubes, implanted or indwelling devices,instruments, other medical devices). Biofilms con-tain viable and nonviable microorganisms thatadhere to the surface and are trapped within amatrix of organic matter (eg, proteins, glycopro-teins, carbohydrates), which prevents antimicrobialagents from reaching the cells.

Biological indicator: A sterilization process-moni-toring device commercially prepared with a knownpopulation of highly resistant spores that tests theeffectiveness of the method of sterilization beingused. The indicator is used to demonstrate that con-ditions necessary to achieve sterilization were metduring the sterilizer cycle being monitored.

Chemical indicator: A sterilization-monitoringdevice used to monitor the attainment of one ormore critical parameters required for sterilization.A characteristic color or other visual change indi-cates a defined level of exposure based on theclassification of the chemical indicator used.

Class 5 chemical integrating indicator: A chemi-cal indicator designed to react to all critical param-eters over a specified range of sterilization cyclesand whose performance has been correlated to theperformance of the stated test organism under thelabeled conditions of use.

RP: Sterilization


Decontamination: Any physical or chemicalprocess that removes or reduces the number ofmicroorganisms or infectious agents and rendersreusable medical products safe for handling or dis-posal; The process by which contaminants areremoved, either by hand cleaning or mechanicalmeans, using specific solutions capable of render-ing blood and debris harmless and removing themfrom the surface of an object or instrument.

Dynamic air-removal: Mechanically assisted airremoval from the sterilization chamber. Includesprevacuum and steam-flush pressure-pulse steamsterilizers.

Dynamic air-removal test (ie, Bowie-Dick test):A diagnostic test to determine the adequacy of airremoval from the chamber of a dynamic-air-removal steam sterilizer. The air-removal test is nota test for sterilization.

Downtime: A period of time when an item ordevice is not operational.

Emergency spill plan: A plan of action for anyunanticipated release of ethylene oxide or otherhazardous chemicals into the workplace.

Flash sterilization: A process designed for thesteam sterilization of patient care items for imme-diate use.

Gravity-displacement sterilizer: Type of steriliza-tion cycle in which incoming air displaces residualair through a port or drain near the bottom of thesterilizer chamber.

Physical monitor: Automated devices (eg,graphs, gauges, printouts) that monitor sterilizationparameters for the sterilization method in use.

Process challenge device: A predetermineditem/package (ie, test pack) designed to simulatethe product to be sterilized and that is used toassess the efficacy of the sterilization process.

Prevacuum steam sterilizer: A steam sterilizationcycle in which air is removed from the chamber andload via a series of pressure and vacuum excursions.

Shelf life: The length of time an item is consid-ered sterile and safe to use.

Short-term exposure limits: Durations of expo-sure to a potentially toxic or harmful substancelasting for less than 15 minutes that cannot berepeated more than four times per day.

Steam-flush pressure-pulse (SPPP): A steam ster-ilization cycle in which air is removed from thechamber and load via a series of steam flushes andpressure pulses.

Sterilization process monitoring device: Adevice used to monitor sterilization processes. Ster-ilization monitoring devices can be biological,chemical, or physical.

REFERENCES1. Petersen, C, ed. Perioperative Nursing Data Set.

Rev 2nd ed. Denver, CO: AORN, Inc: 2007.2. Recommended practices for cleaning and care of

surgical instruments and powered equipment. In: Stan-dards, Recommended Practices, and Guidelines. Denver,CO: AORN, Inc; 2008:421-446.

3. Association for the Advancement of Medical Instru-mentation. ANSI/AAMI ST79: 2006—ComprehensiveGuide to Steam Sterilization and Sterility Assurance inHealth Care Facilities. Arlington, VA: Association for theAdvancement of Medical Instrumentation, 2006:4,24-25,36-37,39,54,60,62-74,77-80,83,87,90,110.

4. Alvarado CJ, Reichelderfer M. 1997-1999 APICGuidelines Committee: APIC guideline for infection pre-vention and control in flexible endoscopy. AmericanJournal of Infection Control. 2000;28:138-155.

5. Recommended practice for traffic patterns in theperioperative practice setting. In: Standards, Recom-mended Practices, and Guidelines. Denver, CO: AORN,Inc; 2007:703-706.

6. Recommended practices for selection and use of packaging systems. In: Standards, RecommendedPractices, and Guidelines. Denver, CO: AORN, Inc;2007:607-616.

7. Association for the Advancement of Medical Instru-mentation. ANSI/AAMI/ISO 11607—Packaging for Ter-minally Sterilized Medical Devices. Arlington, VA: Asso-ciation for the Advancement of Medical Instrumentation,2000.

8. Position statement on ergonomically healthy work-place practices. In: Standards, Recommended Practices,and Guidelines. Denver, CO: AORN, Inc; 2007:382.

9. Joslyn LJ. Sterilization by heat. In: Disinfection,Sterilization, and Preservation. 5th ed. Block SS, ed.Philadelphia, PA: Lippincott Williams & Wilkins; 2001:695-728.

10. Association for the Advancement of MedicalInstrumentation. ANSI/AAMI ST8—Hospital steam steril-izers. Arlington, VA: Association for the Advancement ofMedical Instrumentation; 2001.

11. Clement L, Bliley J. Cracking the steam sterilizerdoor: Dispelling the myth. Healthcare Purchasing News.May 2007:40-42.

12. Mangram AJ, Horan TC, Pearson ML, Silver LC,Jarvis WR. Guideline for prevention of surgical site infec-tion, 1999. [Special Report]. Infection Control and Hos-pital Epidemiology. 1999; 20:250-278. Available athttp://www.cdc.gov/ncidod/dhqp/pdf/guidelines/SSI.pdf.October 26, 2007.

13. Conviser S. The Future of Ethylene Oxide Steriliza-tion. Infection Control Today. June 2000. Available at http://www.infectioncontroltoday.com/articles/061feat4.html.Accessed October 26, 2007.

RP: Sterilization


14. US Environmental Protection Agency. Code ofFederal Regulations Title 40: Protection of Environment,Part 261Identification and Listing of Hazardous Waste.Available at http://www.epa.gov/epahome/cfr40.htm.Accessed October 26, 2007.

15. Association for the Advancement of MedicalInstrumentation. ANSI/AAMI ST41—Ethylene Oxide Ster-ilization in Health Care Facilities: Safety and Effective-ness. Arlington, VA: Association for the Advancement ofMedical Instrumentation; 2000.

16. Joslyn LJ. Gaseous chemical sterilization. In: Dis-infection, Sterilization, and Preservation. 5th ed. BlockSS, ed. Philadelphia, PA: Lippincott Williams & Wilkins;2001:337-359.

17. Crane T, Preziotti R. Hospital sterilization after theCFC phase out. [Viewpoint]. Surgical Services Manage-ment. 1996;2:10-11.

18. US Department of Labor, Occupational Safety andHealth Administration. 29 CFR 1910.1047, Ethylene oxide.Available at http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10070.Accessed October 26, 2007.

19. Material Safety Data Sheet: Ethylene Oxide Steri-lant, April 23, 2007. St. Louis, MO: STERIS Corporation:2007:1-2.

20. US Department of Labor, Occupational Safetyand Health Administration. Hazard communication inthe 21st century workplace; March 2004. Available athttp://www.osha.gov/dsg/hazcom/finalmsdsreport.html.Accessed October 26, 2007.

21. Schneider PM. Ethylene oxide sterilization:employee monitoring. In: Sterilization Technology for theHeath Care Facility. 2nd ed. Reichert M, Young JH, eds.Gaithersburg, MD: Aspen Publishers; 1997:220-227.

22. National Institute for Occupational Safety andHealth. Appendix I Guidelines For Minimizing WorkerExposure To Ethylene Oxide. Current Intelligence Bulletin35. Available at http://www.cdc.gov/niosh/81130_35.html#Recommendations. Accessed October 26, 2007.

23. US Department of Labor, Occupational Safetyand Health Administration. 29 CFR 1910.1020, Accessto employee exposure and medical records. Available athttp://www.osha.gov/pls/oshaweb/owadisp.show _document?p_table=STANDARDS &p_id=10027.Accessed October 26, 2007.

24. Material Safety Data Sheet 09461-0-001: Hydro-gen Peroxide Solution, August 7, 2003. Irvine, CA:Advanced Sterilization Products; 2003:1-8.

25. Rutala WA, Gergen MF, Weber DJ. Comparativeevaluation of the sporicidal activity of new low-tempera-ture sterilization technologies: ethylene oxide, 2 plasmasterilization systems, and liquid peracetic acid. AmericanJournal of Infection Control. 1998;26:393-398.

26. Jacobs PT, Lin SM. Sterilization processes utilizinglow-temperature plasma. In: Disinfection, Sterilization,and Preservation. 5th ed. Block SS, ed. Philadelphia, PA:Lippincott Williams & Wilkins; 2001:747-763.

27. Malchesky PS. Medical applications of peraceticacid. In: Disinfection, Sterilization, and Preservation. 5th

ed. Block SS, ed. Philadelphia, PA: Lippincott Williams &Wilkins; 2001:979-996.

28. Association for the Advancement of MedicalInstrumentation. AAMI ST58 Chemical Sterilization andHigh Level Disinfection in Health Care Facilities. Arling-ton, VA: Association for the Advancement of MedicalInstrumentation; 2005.

29. Smith DF. STERRAD 200 Sterilization System.Advanced Sterilization Products: 2000: 1-22. Available at:http://sterrad.com/SI/Products_&_Services/STERRAD/ STERRAD_200_GMP/Literature/200_white_paper.pdf.Accessed October 26, 2007.

30. Recommended practices for cleaning and pro-cessing endoscopes and endoscope accessories. In: Stan-dards, Recommended Practices, and Guidelines. Denver,CO: AORN, Inc;2007:531-536.

31. Weavers LK, Wickramanayake GB. Disinfectionand sterilization using ozone. In: Disinfection, Steriliza-tion, and Preservation. 5th ed. Block SS, ed. Philadel-phia, PA: Lippincott Williams, & Wilkins; 2001:205-214.

32. Association for the Advancement of MedicalInstrumentation. ANSI/AAMI ST40—Table-top Dry Heat(Heated Air) Sterilization and Sterility Assurance inHealth Care Facilities. Arlington, VA: Association for theAdvancement of Medical Instrumentation; 2004.

33. ASHCSP/IAHCSMM Position Paper on LoanerInstrumentation. http://www.iahcsmm.org/current_issues_Joint_paper_loaner_instrumentation.htm. Accessed Octo-ber 26, 2007.

34. US Department of Health and Human Services;Centers for Medicaid and Medicare Services (CMS) StateOperations Manual Appendix L, §416.42 Condition forCoverage: Surgical Services, http://www.cms.hhs.gov/manuals/downloads/som107ap_l_ambulatory.pdf.Accessed October 26, 2007.

35. US Department of Health and Human Services;Centers for Medicaid and Medicare Services (CMS) StateOperations Manual Appendix A§482.51 Condition ofParticipation: Surgical Services, http://www.cms.hhs.gov/manuals/downloads/som107ap_a_hospitals.pdf.Accessed October 26, 2007.

36. Medical device reporting: manufacturer reporting,importer reporting user facility reporting, distributor report-ing; final rule. Federal Register. 2000;65 no 17:4112-4121.Also available at http://www.fda.gov/OHRMS/DOCKETS/98fr/012600c.pdf. Accessed October 26, 2007..

37. Recommended practices for product selection inperioperative practice settings. In: Standards, Recom-mended Practices, and Guidelines. Denver, CO: AORN,Inc; 2007:637-640.

38. Association for the Advancement of MedicalInstrumentation. ANSI/AAMI/ISO 15882 Sterilization ofHealth Care Products-Chemical Indicators-Guidance forthe Selection, Use, and Interpretation of Results. Arling-ton, VA: Association for the Advancement of MedicalInstrumentation; 2003.

39. Recommended practices for sterilization in the peri-operative setting. In: Standards, Recommended Practices,and Guidelines. Denver, CO: AORN, Inc; 2007:673-687.

RP: Sterilization


RP: Sterilization


RESOURCESBailey A. Updating sterilization technology. Infection

Control and Sterilization Technology. 1995;2:31-33. Bastedo G. Ethylene oxide sterilization. [Viewpoint]. Sur-

gical Services Management. 1995;1:14-15.Bronowicki JP, Venard V, Botte C, et al. Patient-to-patient

transmission of hepatitis C virus during colonoscopy.[Brief Report]. New England Journal of Medicine.1997;337:237-240.

Centers for Disease Control and Prevention. Bron-choscopy-related infections and pseudoinfections—New York, 1996 and 1998. Morbidity and MortalityWeekly Report. 1999;48:557-576. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4826a1.htm. Accessed August 3, 2007.

Chobin N. Cost analysis of three low-temperature sterili-zation systems at Saint Barnabas Medical Center.Journal of Healthcare Materiel Management.1994;12:29-32.

DesCoteaux JG, Poulin EC, Julien M, Guidon R. Residualorganic debris on processed surgical instruments.AORN Journal. 1995;62:23-30.

Gross D. Ethylene oxide sterilization and alternativemethods. [Viewpoint]. Surgical Services Manage-ment. 1995;1:16-18.

Lagergren E. Gas plasma sterilization. [Viewpoint]. Surgi-cal Services Management. 1995;1:26-28.

Spry C. Sterilization regulations—who’s in charge here?[Focus on Quality]. Surgical Services Management.1995;1:56-59.

Tablan OC, Anderson LJ, Besser R, et al. Guidelines for pre-venting health care-associated pneumonia, 2003. Rec-ommendations of the Centers for Disease Control andPrevention and the Healthcare Infection Control PracticesAdvisory Committee. Morbidity and Mortality WeeklyReport. 2004;53 no RR03:1-36. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5303a1.htm.Accessed August 3, 2007.

Ward SF. Today’s new sterilization technology presentsnew decision variables. [Editorial]. Surgical ServicesManagement. 1995;1:4-5.

Originally published August 1980, AORN Journal.Format revision July 1982.

Revised February 1987, October 1992. Publishedas proposed recommended practices in July 1994.

Revised; published August 1999, AORN Journal.Reformatted July 2000.

Revised November 2005; published March 2006,AORN Journal.

Revised 2007; published in the 2008 edition ofPerioperative Standards and Recommended Practices.

Documents

Recommended Practices for Sterilization in the ... · 2008 Perioperative Standards and Recommended Practices 577 Saturated steam under pressure is the preferred sterilization method