FLASH STERILIZATION: A “Steaming Hot” Topicmultimedia.3m.com/mws/media/613576O/flash... · Talk about a “steaming hot” topic! Flash sterilization is almost always a subject

Decreasing the risk to your patients by Rose Seavey, RN, MBA, CNOR, CRCST

68 May 2009 MANAGING INFECTION CONTROL

Education & Training

Many thanks to the team at 3M Health Care forworking with Managing Infection Control to providethe following accredited course. IAHCSMM hasawarded one (1) contact point for completion of thiscontinuing education lesson toward IAHCSMMrecertification. The CBSPD has preapproved thisinservice for one and one-half (1.5) contact hoursfor a period of five (5) years from the date of publi-cation, and to be used only once in a recertificationperiod. This inservice is 3M Health Care Providerapproved by the California Board of RegisteredNurses, CEP 5770 for one (1) contact hour. Thisform is valid up to five (5) years from the date ofpublication. Instructions for submitting results areon page 89.

Managing Infection Control and 3M HealthCare will be working collaboratively to providecontinuing education courses in monthly editions ofManaging Infection Control .

ObjectivesAfter completion of this self-study activity, the learner

will be able to:1. Define flash sterilization.2 Discuss the Association of periOperative Registered

Nurses (AORN) and the Association for theAdvancement of Medical Instrumentation’s (AAMI’s)recommended practice on flash sterilization.

3. Identify quality control measures and documentationfor flash sterilization.

4. Explain why flash sterilization of implants is notrecommended.

Test QuestionsTrue or False. Circle the correct answer.

1. The two biggest concerns with flash sterilization arethe pre-cleaning and transportation to the point of use.A. True B. False

2. Attempting to clean instruments in a scrub sink or hand sinkis acceptable if you are going to flash the item.A. True B. False

3. Instruments needing to be flashed sterilized should receivethe same standard of cleaning/decontamination as all otherdevices.A. True B. False

4. Some instrument manufacturers caution against the use offlash sterilization for their devices.A. True B. False

5. All three types of sterilization monitors: physical, chemicaland biological are necessary for flash sterilization moni-toring. A. True B. False

6. The Association for the Advancement of MedicalInstrumentation (AAMI) and the Association forperiOperative Registered Nurses (AORN) recommend flashsterilization of implants.A. True B. False

7. AAMI and AORN recommend that implants should be moni-tored with a biological indicator process challenge device (BIPCD) that contains a Class 5 integrating indicator and quar-antined until the biological indicator (BI) result is available. A. True B. False

8. Healthcare facilities need to develop written guidancedefining what constitutes emergency situations whenimplants can be released before the BI result is available.A. True B. False

9. Documentation of cycle information and monitoring resultsof every load sterilized should be maintained to providetracking of flashed items(s) to the individual patient. A. True B. False

10. Planning ahead, appropriate packaging, monitoring with a BIand Class 5 integrating indicator, and inventory managementin cooperation with vendors can help decrease the need toflash sterilize implants. A. True B. False

FLASH STERILIZATION:

A “Steaming Hot” Topic



with little or no drying time; in many different types of packaging;

• perforated, mesh bottom, open, surgical tray;• containment devices;• protective organizing cases;• rigid sterilization containers;• single-wrapped surgical trays; and

by immediately transferring the processed items to thesterile field using aseptic technique.2

Placing instruments in a container system in a dynamic-air-removal sterilizer is still flash sterilization if there is littleor no drying time. If the container system cannot be stored forfuture use it is considered flash sterilization.1,2

Risks and Concerns with Flash Sterilization Items requiring flash sterilization are needed immediately

and therefore, time pressures may cause staff to skip vitalsteps in the cleaning and other decontamination processes.Reduction of bioburden by efficient cleaning is a crucial stepin preparation of devices for sterilization of any method. It hasbeen well documented that when items are not properlycleaned they cannot be sterilized, therefore putting patients atrisk. There are also risks involved to the worker if correctdecontamination processes are not followed.2

“Failures in instrument cleaning have resulted in transmission of infectious agents.”1 Because of the risksinvolved to both patients and healthcare professionals, flashsterilization should not be used as an excuse for inadequateinstrument inventory.1

Attempting to clean instruments in a scrub sink or handsink is not acceptable, and will contaminate the sink normallyused for handwashing/scrubbing. Decontamination shouldalways be done in a designated area, by personnel wearingappropriate personal protective equipment (PPE) with theappropriate cleaning agents, tools and water quality.

Flash sterilization should be reserved for single itemshowever, we know in the “real world” large instrument traysand multiple trays are being flashed. Flashing large and/ormultiple trays results in increased challenges. The large metalmass increases the heat up time, which increases the total cycletime. The cooling time is also a factor. Many manufacturers’instructions warn us not to cool instruments with sterile waterbecause it could have an ill effect on the metal. Not waiting forthe instruments to cool could cause burns to the patient.

Issues with Eye Instruments

Instruments used for intraocular surgery need specialconsiderations due to the characteristics of the instruments andthe sensitive nature of the eye and to avoid TASS. TASS is toxicanterior segment syndrome (TASS), a condition resulting in

IntroductionTalk about a “steaming hot” topic! Flash sterilization is

almost always a subject that comes up in a conversation aboutsterilization. There are many concerns and a lot of people getsteamed up over flash sterilization.

Flash sterilization has gotten a bad name over the years.Sterilizers designated for “flashing” are just smaller sterilizersthat are as efficacious as their larger cousins. Sterile is sterile,period. The problem is in the pre-cleaning of the instrumenta-tion to be flashed sterilized and the transportation of theseitems to the point of use.

Of course, the most important concern is patient safety.As healthcare providers our biggest responsibility is to minimize patient risks. When evaluating flash sterilization in a facility we should first look at why items are being flashedinstead of using the preferred wrapped or container method. Is it done only for emergencies, for convenience, lack ofinstrument inventory, lack of trust between the operating room(OR) and the sterile processing department (SPD), schedulingissues or issues with loaner instruments?

According to the Association of periOperative RegisteredNurses (AORN) Recommended Practices for Sterilization inPerioperative Practice Settings:

“Flash sterilization may be associated with increasedrisk of infection to patients because of pressure on personnelto eliminate one or more steps in the cleaning and steriliza-tion process.”1

This inservice will address current recommended practicesand opportunities for improvement with the use of flash sterilization in the healthcare setting.

Flash Sterilization DefinedFlash sterilization has been defined in many ways

such as: “A process designed for the steam sterilization of patient

care items for immediate use.”1,2

“The process by which unwrapped instruments are sterilizedfor immediate use when an emergency situation arises.”3

“Process designed for steam sterilization of unwrappedpatient-care items for immediate use (or placed in aspecially designed, covered, rigid container to allow forrapid penetration of steam).”4

The common theme in all of these definitions is that flashsterilization should only be used for immediate use and in anemergency situation.

Presently flash sterilization is performed: at 270-275°F (132-135°C); in both gravity and dynamic-air-removal (i.e., prevacuum

or steam-flush pressure-pulse) sterilizers; for ≥3 minutes;



acute inflammation of the anterior segment of the eye aftercataract surgery.5 Some of the identified causes of TASS are“irritants on the surfaces of intraocular surgical instrumentsthat have accumulated as a consequence of inadequate orinappropriate instrument cleaning, detergents, heat stableendotoxin from overgrowth of gram-negative bacilli inwater baths of ultrasonic cleaners, degradation of brasscontaining surgical instruments from plasma gas steriliza-tion and impurities of auto-clave steam.”5

Eye instruments are hard to clean because of thevery small lumens and the practice of using viscoelasticproducts which are difficult to remove. Eye instrumentstend to be so complex and delicate they can only beprocessed manually. Because manual cleaning is lesscontrolled, than mechanical processes, additional caremust be taken for efficient cleaning.6

In some facilities, especially those that do a lot of eyesurgery, it is common practice to flash eye instruments.This is mostly due to an insufficient quantity of sets for the number of cases scheduled. Therefore, if it is necessary to flash sterilize eye instruments they should bemeticulously cleaned following the manufacturer’s writteninstructions. It should also be noted that The JointCommission is very concerned about the flash sterilizationof eye instruments. Some facilities have been sited during surveys and subsequently had to purchase enoughinstrument inventory to eliminate flash sterilization, whichshould be the goal of all healthcare facilities.

Recommendations for reducing the risk of TASS inthe overall context of surgical instrument processing inhealthcare facilities can be found in a new Annex N in ANSI/AAMMI ST79:2006:A1:2008 which was just published in the last few months. Some of the recommendations inthe annex are to ensure facilities: have adequate inventory of instrument sets; have a designated cleaning area and equipment just

for eye instruments; follow manufacturer’s written instructions for

cleaning and sterilization; audit the sterilization process; perform immediate precleaning; use only manufacturer’s recommended cleaning

agents, and appropriate water quality; and have resource training.2

The AORN 2009 Recommended Practices for Cleaningand Care of Surgical Instruments and Powered Equipment7

is another reference but the most comprehensive referenceis the Recommended practices for cleaning and sterilizingof intraocular surgical instruments, The Journal of CataractRefractive Surgery, Vol. 33, June 2007.5

Efficacy of the Steam Sterilization ProcessThe steam sterilization process has four phases that are signif-

icantly dependant on each other to produce and maintain a sterileproduct. The efficacy of saturated steam sterilization depends on:1. A reliable system for lowering and limiting bioburden before

sterilization;2. Appropriately preparing devices for sterilization;3. Selecting the correct sterilization parameters; and4. Establishing and implementing controls to maintain the

sterility of sterilized items until they are used.2

AAMI Guidelines for Flash SterilizationAccording to the Association for the Advancement of Medical

Instrumentation (AAMI) a flash sterilization cycle should meet thefollowing criteria:(a) “The cycle is preprogrammed to a specific time-temperature

setting established by the manufacturer based on the type ofsterilizer control (i.e., gravity-displacement, dynamic-air-removal) and selected by the user based on the configurationof the load (i.e., the presence or absence of porous materials).

(b) The items to be processed are usually unwrapped, although asingle wrapper may be used in certain circumstances if the ster-ilizer and packaging manufacturer’s instructions permit. Somerigid sterilization container systems have been designed and validated by the container manufacturer for use with flash cycles.

(c) Since drying time is not usually part of a preprogrammed flash cycle, the items processed are assumed to be wet at theconclusion of the cycle.

(d) The processed item(s) must be transferred immediately, usingaseptic technique, from the sterilizer to the actual point of use,usually the sterile field in an ongoing surgical procedure.Regardless of whether the items are wrapped, there is nostorage or shelf life of flash-sterilized items because of thehigher probability of contamination after the sterilizer door isopened and the items are removed.”2

AAMI states that flash sterilization should only be used if allof the following conditions are met:(a) “Work practices ensure proper cleaning and decontamination,

inspection, and arrangement of instruments into the recom-mended sterilizing trays or other containment devices beforesterilization.

(b) The physical layout of the department or work area ensuresdirect delivery of sterilized items to point of use (e.g., the sterilizer opens into an area either within or directly adjacentto the procedure room).

(c) Procedures are developed, followed, and audited to ensureaseptic handling and personnel safety during transfer of thesterilized items from the sterilizer to the point of use.

(d) The item is needed for use immediately following flash steril-ization.”2



Load Contents

Unwrapped nonporousitems (e.g., instruments)

Unwrapped nonporous andporous items in mixed load

Unwrapped nonporousitems (e.g., instruments)

Unwrapped nonporous andporous items in mixed load

Sterilization Time

3 minutes3 minutes

10 minutes10 minutes

3 minutes3 minutes

4 minutes3 minutes

Type of Sterilizer

Gravity-Displacement


Dynamic-Air-Removal

Dynamic-Air-Removal

Sterilization Temperature

270°F (132°C)275°F (135°C)

270°F (132°C)275°F (135°C)

270°F (132°C)275°F (135°C)

270°F (132°C)275°F (135°C)

Dry Time

0 to 1 minute0 to 1 minute



0 to 1 minute

0 to 1 minute

Notes:

AORN Guidelines for Flash SterilizationFlash sterilization should be used only in selected

clinical circumstances and in a restricted manner and the use of flash sterilization should be kept to a bareminimum. Instruments needing to be flashed sterilizedshould receive the same standard of decontamination as allother devices. This recommendation is based on the factthat “flash sterilization may be associated with increasedrisk to patients because of pressure on personnel to elimi-nate one or more steps in the cleaning and sterilizationprocess.”1 AORN recommends the following:

Flash sterilization should be performed only if allof the following conditions are met: “The device manufacturer’s written instructions on

cycle type, exposure times, temperature setting,and drying times (if recommended) are availableand followed.

Items are disassembled and thoroughly cleanedwith detergent and water to remove soil, blood,body fats, and other substances.

Lumens are brushed and flushed under water witha cleaning solution and rinsed thoroughly.

Items are placed in a closed sterilization containeror tray, validated for flash sterilization, in a manner that allows steam to contact all instrumentsurfaces.

Measures are taken to prevent contaminationduring transfer to the sterile field.”1

“Flash –sterilized items are to be used immediatelyand not stored for later use.”1

Cycle SelectionSelecting the correct cycle and drying time for flash cycles is

important for effective sterilization. Table 1 shows minimum flashsterilization parameters recommended by sterilizer manufacturers.However, the Medical Device Manufacture’s (MDM’s) writteninstructions should be followed regarding appropriate cycle selectionas well as cleaning and disassembly instructions for the instruments.Some MDM’s instructions actually do not recommend flash sterilization of their instruments because they contain implants andthe sterilization times at 270-275°F (132-135°C) in gravity steamsterilizers are too long to be practical. You should also check withthe MDM of the packaging material (wrap or containers) for theirinstructions regarding flash sterilization.

Sterilization MonitoringAORN’s current recommended practices for sterilization in the

perioperative practice setting declares a steam sterilization qualitycontrol program should be established and maintained.1 All flashloads should be monitored to verify the effectiveness of the process.There are three types of sterilization monitors that are necessary:physical monitors, chemical indicators and biological indicators.

Physical Monitors

Physical monitors are the time, temperature and pressurerecorders, otherwise known as the gauges, graph, and printouts. Toverify the physical monitors are functioning properly, they should beexamined before the start of a cycle. At the end of the cycle and beforethe items are removed from the sterilizer, the physical monitor shouldbe reviewed for correct conditions for the load content. The sterilizeroperator should initial the physical monitor verifying that all theparameters were met (see Figure 1 on page 76).

• For wrapped items (i.e., rigid containers andcontainment devices), check with the manu-facturer of the containers and instruments forsterilization process instructions.

• If processing single wrapped trays in the express cycle, check withthe sterilizer manufacturer for sterilization process instructions.

• If processing lumens, check with the manufacturer of the instruments for sterilization process instructions.

Table 1. Minimum Flash Sterilization Parameters Recommended by Sterilizer Manufacturers2

container should also contain CIs because this is even more challenging for air removal and ster-ilant penetration.

3. Bowie Dick tests are used to detect air leaks,inadequate air removal, inadequate steam pene-tration and the presence of non-condensablegases in dynamic-air-removal sterilizers and areconsidered Class 2 indicators for use in specifictests. Dynamic-air-removal sterilizers should betested with a Bowie-Dick test pack every daybefore the sterilizer is used and for sterilizer qualification testing.2

Biological Indicators

Biological indicators (BIs) for steam sterilizers aremade using highly resistant spores called Geobacillusstearothermophilus. “Biological indicators are the onlysterilization process monitoring device that provides a direct measure of the lethality of the process,” andshould be used to routinely test sterilizer efficacy, forload release, and for sterilizer qualification.2

Figure 1. Physical Monitor

If the physical monitor results are not correct or show a suspiciousoperation, the items should not be considered sterile and the loadshould not be released for patient use. The sterilizer should not be useduntil the malfunction is corrected.2

Chemical Indicators

The three types of chemical indicators (CIs) for steam sterilizationare external, internal and Bowie-Dick tests.1. External chemical indicators are placed on the outside of every

package or container to determine if the item went through thesterilization process. There is no place for an external indicator ifitems are flash sterilized in an open tray so the internal chemicalindicator is also the external chemical indicator. However, AORNrecommends flashing in a closed sterilization container or tray,validated for flash sterilization.1 When using a closed container forflashing, an chemical indicator should be affixed to the outside ofthe tray as an external chemical indicator.

2. Internal chemical indicators are used to monitor the conditionsinside the individual tray or pack to determine that the sterilant haspenetrated to the location of the medical device. These can beeither Class 3 single variable indicators, Class 4 multi-variableindicators, or Class 5 integrating indicators.2 AORN states that“Class 5 chemical integrating indicators should be used withineach sterilizer container or tray.”1

AORN advises that internal CIs should be placed in the area creating the biggest challenge for air removal and sterilantpenetration. For wrapped packages, that is the geometric center ofthe pack. For rigid containers, two CIs should be used, one in twoopposite corners in each level on the inside of the basket. If thecontainer has multi-levels and is normally wrapped, the CIs shouldbe placed in the geometric center and on each level.8 If there areany containers within containers being sterilized, the internal



Figure 2. Class 5 Integrating Indicator in a PerforatedMesh Bottom Tray

Figure 3. Class 5 Integrating Indicator in a Container



Type of Cycle




Dynamic-air-removal

Dynamic-air-removal

Dynamic-air-removal

Type of Tray Configuration

Open, perforated, mesh bottom surgical tray

Protective organizing case

Rigid sterilization container

Open, perforated, mesh bottom surgical tray with or without porous item (towel, foam pad, etc.)

Protective organizing case

Rigid sterilization container

BI PCD

BI and CI in open, perforated, mesh bottom surgical tray. (See Figure 6 on page 80.)

BI and CI in protective organizing case in area(s) thatcreate(s) the greatest challenge to air removal and sterilantpenetration. See AORN recommendations.8

BI and CI in rigid sterilization container in area(s) thatcreate(s) the greatest challenge to air removal and sterilantpenetration. See AORN recommendations.8 (See Figure 7on page 80.)

BI and CI in open, perforated, mesh bottom surgical tray(include porous items if in patient care tray). (See Figure 8on page 80.)

BI and CI in protective organizing case in area(s) thatcreate(s) the greatest challenge to air removal and sterilantpenetration. See AORN recommendations.8

BI and CI in rigid sterilization container in area(s) thatcreate(s) the greatest challenge to air removal and sterilantpenetration. See AORN recommendations.8 (See Figure 9on page 80.)

• Monitor each type of tray configuration used.2

Each type of tray configuration produces adifferent challenge for air removal and thereforesteam penetration. So if you use both an opensurgical tray and a rigid container, then you need totest each with a BI at least weekly but preferablyevery day the sterilizer is used in each type of cycleand tray configuration used. See Table 2 for a listof different cycle/tray combinations that may beused for flash sterilization and the appropriate BIPCD to use.

Some healthcare facilities test each load witha BI PCD to ensure that all types of cycles andtray configurations are tested as recommended.

With every load containing implants which should bequarantined until the BI result is available. A Class 5 integrating indicator should be included in the BI PCD.1,2

*Sterilization times determined by medical device orsterilizer manufacturer.

# Commercially available BI PCDs may be used ifdesigned for the type of cycle, time and temperature and ifthey create a challenge that is equal to or greater then the typeof tray configuration.

Note: Negative BI results from a cycle run with the open, perforated, meshbottom surgical tray indicate that the process is killing spores. If other tray configura-tions produce positive BI results this suggests that air is not being removed and thatsteam is not penetrating inside that other tray configuration. This could be a problemwith the performance of the tray configuration or the cycle parameters chosen forprocessing that tray configuration.2

Table 2. BI PCDs for Different Cycle/Tray Configurations for Routine Testing of a Flash Sterilization Cycle*#

Load control is a monitoring and load release process whichrelies on the result of a BI which was located in a process challengedevice (PCD), commonly known as a test pack.

According to ANSI/AAMI ST79 BIs should be used in PCDs: To routinely monitor sterilizers at least weekly, but preferably

every day the sterilizer is used. See Figure 5 for instructions on performing routine sterilizer efficacy testing and acceptancecriteria.• Monitor every type of cycle used. Each cycle run produces

a different challenge for air removal and therefore steampenetration. This means if you use flash at 132°C to 135°C[270°F to 275°F] in both gravity and dynamic-air-removalsteam sterilizers or flash with single wrapper or otherpackaging all of these cycles need to be tested.2

Note: “If a sterilizer will run the same type of cycle (e.g.,dynamic-air-removal at 132°C to 135°C [270°F to 275°F] fordifferent exposure times (e.g., 4 minutes and 10 minutes),then only the shortest cycle time needs to be tested.”2

Figure 9.



Figure 8.

Figure 7. Figure 6.

BI and Class 5IntegratingIndicator in OppositeCorners in RigidSterilizationContainer inGravity FlashSterilization

BI and Class5 IntegratingIndicator in Open,Perforated,Mesh BottomSurgical Trayfor Dynamic-Air-RemovalFlashSterilization

BI and Class5 IntegratingIndicator in OppositeCorners in RigidSterilizationContainer inDynamic-Air-RemovalFlashSterilization

BI and Class5 IntegratingIndicator in Open,Perforated,Mesh BottomSurgical Tray forGravity FlashSterilization

Test Procedure:1. Run an empty cycle to preheat the sterilizer and purge

air out of the lines, even if the sterilizer was neverturned off.

2. Run a Bowie-Dick test if it is a dynamic-air-removalsterilizer.

3. Choose the appropriate BI process challenge device(PCD) (see Table 2) for each sterilization mode orcycle and tray configuration used daily.

4. Place one or more BIs and one or more CIs in the areas of the tray configurations determined to create the greatest challenge to air removal and sterilant netration.

5. Place the BI PCD flat or according to the manufac-turer’s instructions in an empty chamber on a rack orshelf near the drain. Empty chamber testing createsthe greatest challenge because it minimizes the effectof heat-up time on spore kill that occurs when a heavy

Figure 5. Routine Sterilizer Efficacy Testing of Flash Sterilization Processes

metal mass is in the load. Do not place another pack or tray on top of the BI PCD. This will create too greatof a challenge.

6. Run the load according to the sterilizer manufacturer’sinstructions.

7. Read the physical monitors, verify, and initial the printout.8. At the end of the cycle, cool the BI PCD and BI

according to the manufacturer’s instructions.9. Read the CI and record the results.

10. Incubate the test BI and a positive control BI from the same lot each day a test vial is incubated in the sameauto-reader or incubator.

11. Read and record the results.

Acceptance Criteria:1. Appropriate reading from physical monitors.2. Appropriate readings from the CIs.3. Negative BI results from all test BIs in the load.9



ImplantsAccording to the Food and Drug Administration (FDA),

an implant/implantable device is a “device that is placed into a surgically or naturally formed cavity of the human body if itis intended to remain there for a period of 30 days or more.FDA may, in order to protect public health, determine thatdevices placed in subjects for shorter periods are also‘implants’.” [21 CFR 812.3(d)].10

Ideally implants and implantable devices should come individually wrapped and sterile from the manufacturer.Sometimes this is not feasible and the implantable devices mustbe processed by the healthcare facility. For effective steriliza-tion it is vital to follow the manufacturer’s written instructionsfor the appropriate sterilization time for each type of implant.

Implants Should Not be Flash Sterilized

AORN’s 2009 Recommended Practice on Sterilization inthe Perioperative Practice Setting recommends against flashsterilization of implants.

“Flash sterilization should not be used for implantabledevices except for cases of emergency when no other optionis available.

Implants are foreign bodies, and they increase the risk of surgical site infections. Careful planning, appropriate packaging, and inventory management in cooperation withsuppliers can minimize the need to flash sterilize implantablemedical devices.

In an emergency, when flash sterilization of an implant is unavoidable, a rapid-action BI with a Class 5 chemical integrating indicator (or enzyme only indicator) should be runwith the load.

If the implant is used before the BI results are known andthe BI is later determined to have a positive result, the surgeonand infection prevention and control personnel should be notified as soon as the results are known.”1

Note: The enzyme only indicator is no longer commer-cially available.

According to AAMI, implants should be held in quarantineuntil the results of the BI is available. In the Comprehensive guideto steam sterilization and sterility assurance in health carefacilities (ANSI/AAMI ST79: 2006 and A1:2008), specificrecommendations on the release criteria for implants is spelledout (10.6.3).

“As with all cycles, the sterilizer operator should review the sterilizer chart or printout and the results of otherindicators that have been used to monitor the sterilizationprocess. The load should be quarantined until the results of theBI testing are available (CDC, 2003a).

When documented medical exceptions dictate (e.g., theneed for trauma-related orthopedic screw-plate sets), it could benecessary to release an implantable device before the BI results

are known. In this case, the release of the device before the BIresults are known should be documented; the BI result obtainedlater should also be documented. It is critical that this documentation be fully traceable to the patient. Releasingimplants before the BI results are known is unacceptable and should be the exception, not the rule. Emergency situationsshould be defined in written guidance developed in consultationwith infection prevention and control, the surgeon, and riskmanagement. Steps should be taken to reduce the frequency ofemergency release of implantable items. For example, ongoingperiodic reviews of the exception forms and implant logs couldreveal consistent patterns of events that are causing emergencyrelease and that could be corrected.

Rationale: Patient safety could be adversely affected bythe implantation of a nonsterile device. The sterilization ofimplantables should be closely monitored and each loadcontaining implants should be quarantined until it is verifiedthat BI testing has yielded negative results. In defined emergency situations in which the quarantine of implantscannot be maintained, breaking of the quarantine is allowed fordocumented medical exceptions in accordance with facilitypolicies and procedures.”2

Healthcare facilities need to develop written guidance as to what emergency situations are. A definition, such as “life or limb” threatening, and a guidance statement should be developed by a committee that includes infection preventionists,the surgeon and risk management.

Releasing implants before the BI results are known isunacceptable and should be the exception, not the rule. Whenan implantable device is used before the BI results are known,the release of the device without the BI results should be documented on an implant log and an exception form.2

See AAMI ST79 Annex L, reprinted on page 84, for examplesof an implant log and an exception form.

Steps should be taken to reduce the frequency of emergencyrelease of implantable items. For example, ongoing periodicreviews of the exception forms and implant logs could revealconsistent patterns of events that could be corrected.

DocumentationIdeally, every reprocessed medical device, especially an

implant, should be fully traceable to the patient on whom it isused or in whom it is implanted; such traceability can beaccomplished by recording the sterilizer load identifier on thepatient chart or the patient name on the load record.”2

Documentation of cycle information and monitoringresults of every load sterilized should be maintained to providetracking of flashed items(s) to the individual patient.1

Documentation of the flash sterilization cycle is essential andshould be consistent with the facilities requirements applicableto documenting the routine processing of wrapped loads.2


The flash records should include information oneach load documenting the: specific instrument(s) processed; patient’s name; cycle parameters used (i.e. temperature, cycle

time); date and time of run; operator’s identification; and reason necessary for flash sterilization.1

Sterilizer printout should be reviewed at the endof each cycle and signed by the sterilizer operatorconfirming that all sterilization parameters were met.1

This documentation can be recorded electronically(i.e. on the medical record, or in an instrument trackinginformation system) or hard copies can be saved. Figure10 on page 86 is a sample of a flash record that could beused to manually to document flash loads.


Date Description Dept. Time Sterilizer # Load # Date/time Date/time Early Date/time Released of implants sterilized BI in and release? released by

(specify incubator BI result to OR (full name)AM/PM)

Example of documentation of premature release of implantsThis Annex provides an Implantable Devices Load Record and an Exception Form for Premature Release of ImplantableDevice/Tray, as examples of the forms recommended in Section 10.5.3.3.

Implantable Devices Load Record

Figure L.1—Implantable devices load recordAnnex L (Informative)

Record Keeping

Sterilization record retention varies across the country. Eachhealthcare institution must determine its record-retention policy based on state and local regulations, legal considerations (e.g. statutes of limitation for lawsuits) and any individual circumstances. All sterilization records, including flash loads, should be kept in accordance with the individual healthcare facility’s established policy.2

Getting a Handle on Flash SterilizationMost healthcare facilities use some kind of block scheduling for

the OR. This means that surgeons are given blocks of time to scheduletheir cases. This works well for both the surgeon and the OR.Unfortunately, block scheduling is the cause for a lot of the flash sterilization. The physicians want to do back-to-back cases in theirassigned block time. Frequently they need the same type of instrumentsor implants. If the inventory does not allow time to reprocess the itemsin the preferred wrapped method, flashing of the medical devices is

Reprinted with permission from the Association for the Advancement of Medical Instrumentation, Inc. Copyright 2006 AAMI. www.aami.org. All rights reserved.

85May 2009 MANAGING INFECTION CONTROL


Exception Form for Premature Release of Implantable Device/Tray

NOTE—In a documented emergency situation, implantable devices will be released from quarantine in Central Service without the biological monitor result. This form should accompanythe implant to the Operating Room. Operating Room personnel should complete this form andreturn it to Central Service within 24 hours.

PLEASE COMPLETE ALL INFORMATION:

DATE: ___________________________ SHIFT: ____________ TIME: __________ AM PM

PERSON COMPLETING THIS REPORT IN CENTRAL SERVICE: _____________________

The following implantable devices/trays were prematurely released to the Operating Room:

______________________________________________________________________________

______________________________________________________________________________

NAME OF OR PERSON REQUESTING PREMATURE RELEASE OF DEVICES:

_____________________________________________________________________________

OPERATING ROOM REPORT:

PATIENT NAME: ______________________________________________________________

SURGEON NAME: ____________________________________________________________

TIME OF PROCEDURE: ____________________ AM PM DATE: ____________________

REASON PREMATURE RELEASE WAS NEEDED: __________________________________

____________________________________________________________________________

____________________________________________________________________________

WHAT COULD HAVE PREVENTED PREMATURE RELEASE OF THIS DEVICE/TRAY?

_____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

NAME OF OR PERSON COMPLETING THIS REPORT: _______________________________

DATE REPORT COMPLETED: ________ RETURNED TO CENTRAL SERVICE ON: _________

Figure L.2—Exception form for premature release of implantable device/traydone. Purchasing of additional instru-ments that are frequently used is one way to decrease the use of flashsterilization. Reviewing the exceptionforms and implant logs to look for patternsof frequently flashed items is another wayto identify habits that can be changed toreduce the amount of flash sterilization.Another is to schedule a hip, then a kneesurgery or surgeries that require differentinstrumentation and implants after eachother so there is time to properly clean and sterilize using the preferred wrappedor container method.

In New Jersey (NJ) the StateDepartment of Health passed a bill that facilities must abide by the AAMIstandards. They “never outlawed flashsterilization, just made sure it was not used as an excuse for insufficientinstrumentation, bad scheduling or issues with loaner sets.”11 The goal in NJ was,and still is, “that if flash sterilizationMUST be performed, all components ofthe processmust be performed correctlyand documented.”11

This means all flash sterilizationperformed must be in compliance withAAMI standards meaning if they flashthey need to: “Have correct physical location

(separate decontam) area with properventilation, etc. for cleaning ofdevices (no scrub sinks);

Ensure complete cleaning per themanufacturer’s instructions—cleaningin SPD preferred for standardization;

Ensure complete documentation of the process including patient ID #(for traceability), surgeon, device(s)flashed, if a BI was in the load, CIresult, etc. is complete;

Require a policy on flash sterilizationwhich specifies under what condi-tions flash sterilization would beperformed (e.g. one-of-a-kind item);

Document the reason for flash sterilization which they are expectedto use as a process improvement toolto prioritize additional instrumentpurchases or to resolve other issues

Reprinted with permission from the Association for the Advancement of Medical Instrumentation, Inc.Copyright 2006 AAMI. www.aami.org. All rights reserved.

continued on page 88

Reprinted with permission from the Association for the Advancement of Medical Instrumentation, Inc.Copyright 2006 AAMI. www.aami.org. All rights reserved.



Figure 10. Record of Flash Sterilization

Courtesy of The Children’s Hospital of Aurora, Colo.



causing flash sterilization (e.g. loaners received late).”11

SummaryHealthcare providers are responsible for minimizing the risks

to patients. The risk of surgical site infections can be decreased byensuring that all surgical items are free of contamination at thetime of use. Sterilization by the flash method should be used onlywhen there is inadequate time, (e.g., urgent situations) to processby the preferred wrapped or container method. Flash sterilizationshould never be used as a substitute for inadequate instrumentinventory. Planning ahead, appropriate packaging, monitoringwith a BI and a Class 5 integrating indicator, inventory manage-ment and cooperation with vendors can help decrease the need toflash sterilize instruments and implants.1,2 ✛

References1. Recommended Practices for Sterilization in Perioperative Practice

Settings. In: Perioperative Standards and Recommended Practices.Denver, CO: AORN, Inc: 2009.

2. ANSI/AAMI ST79:2006 and A1:2008. Comprehensive guide to steam

sterilization and sterility assurance in health care facilities.Arlington, VA; Association for the Advancement of MedicalInstrumentation: 2008.

3. Central Service Training Manual, 7th edition. Chicago, IL;International Association of Healthcare Central Service MaterielManagement: 2007.

4. Centers for Disease Control. Guideline for the Disinfection andSterilization in Healthcare Facilities. 2008.

5. Recommended practices for cleaning and sterilizing intraocularsurgical instruments, The Journal of Cataract Refractive Surgery,Vol 33: June 2007.

6. Spry, C. Understanding Current Steam Sterilization Recommendationsand Guidelines. AORN Journal. Denver, CO: AORN, Inc; Vol. 88No 4: 537-554: October 2008.

7. Recommended Practices for Cleaning and Care of SurgicalInstruments and Powered Equipment. In: Perioperative Standardsand Recommended Practices. Denver, CO: AORN, Inc: 2009.

8. Recommended Practices for Selection and Use of PackagingSystems for Sterilization. In: Perioperative Standards andRecommended Practices. Denver, CO: AORN, Inc: 2009.

9. Young, M. Flash Dance. How to Monitor the Flash SterilizationProcess. Managing Infection Control. October 2007.

10. U.S. Food and Drug Administration. Medical Devices, Code ofFederal Regulations, Title 21, Part 812.

11. N. Chobin, personnel communication via e-mail: September 27, 2008.

continued from page 85

89May 2009 MANAGING INFECTION CONTROL

Rose Seavey, RN, BS, MBA, CNOR,CSPDT is the president/CEO of SeaveyHealthcare Consulting Inc., and formerlythe director of the Sterile ProcessingDepartment at The Children’s Hospitalof Denver. Ms. Seavey was honored withthe Association of periOperativeRegistered Nurses (AORN) award forOutstanding Achievement in ClinicalNurse Education in 2001. She served asthe president of the American Society ofHealthcare Central Service Professionals(ASHCSP) in 2003 and was the 2002recipient of ASHCSP National Educatorof the Year award. Ms. Seavy was selectedas one of the “Who’s Who in InfectionPrevention” in 2006.

Ms. Seavey is a member of, AORN,ANA, APIC, IAHCSMM and severalAAMI working group committees thatare developing recommended practicesand is currently a co-chair for the ANSI/AAMI ST8, Hospital Steam Sterilizersperformance standard as well as ST55,Tabletop Steam Sterilizers. In additionshe has lectured and authored manyarticles on various topics relating to perioperative services and sterileprocessing, locally, nationally andinternationally.


Nursing CE Application FormThis inservice is approved by the California Board of Registered Nurses, CEP

5770 for one (1) contact hour. This form is valid up to five years from the date of publication.1. Make a photocopy of this form.2. Print your name, address and daytime phone number and position/title.3. Add the last 4 digits of your social security number or your nursing license number.4. Date the application and sign. 5. Answer the true/false CE questions. KEEP A COPY FOR YOUR RECORDS.6. Submit this form and the answer sheet to:

Workhorse PublishingManaging Infection ControlPO Box 25310, Scottsdale, AZ 85255-9998

7. For questions or follow-up, contact [email protected]. Participants who score at least 70% will receive a certificate of completion

within 30 days of Managing Infection Control’s receipt of the application.

ApplicationPlease print or type.

Name______________________________________________________________

Mailing Address______________________________________________________

City, State, Country, Zip _______________________________________________

Daytime phone ( )__________________________________________

Position/Title_______________________________________________________

Social Security or Nursing License Number ________________________________

Date application submitted _____________________________________________

Signature __________________________________________________________

Offer expires May 2014

On a scale of 1-5, 5 being Excellent and 1 being Poor, please rate this programfor the following:

1) Overall content ___________________

2) Met written objectives ______________

3) Usability of content ________________

Sterile Process and Distribution CEU InformationCEU Applicant Name _________________________________________________

Address___________________________________________________________

City____________________________ State________ Zip Code ______________

The CBSPD (Certification Board for Sterile Processing and Distribution) haspre-approved this inservice for one and one-half (1.5) contact hours for a period offive (5) years from the date of publication. Successful completion of the lesson andpost test must be documented by facility management and those records maintainedby the individuals until recertification is required. DO NOT SEND LESSON OR TESTTO CBSPD.

For additional information regarding Certification contact: CBSPD, 121 StateHwy 31N, Suite 500, Flemington, NJ 08822 or call 908-788-3847 or visit the Web siteat www.sterileprocessing.org.

IAHCSMM has awarded one (1) Contact Point for completion of this continuingeducation lesson toward IAHCSMM recertification.

<05/09>

1. A2. B3. A4. A5. A

6. B7. A8. A9. A

10. A

ANSWERS

70-2010-7263-7

Copyright©2009/Workhorse Publishing L.L.C./All Rights Reseved. Reprint with permission from Workhorse Publishing L.L.C.

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