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By Charles O. Hancock, RAC
Many OR users consider flash sterilization to be some kind of magic processthat solves a multitude of inventory problems. In fact, use of flashsterilization requires discipline that few of its users follow. For thosemedical devices prepared for use by a Central Sterile Processing Department (CSPD),it is a given that sterility can be assured and documentation exists to confirmthe status of those devices so prepared. Yet in spite of recommendation to thecontrary1, flash sterilization is routinely carried out in operatingrooms (ORs) every day, often without regard to process performance. Flashsterilization is the technique used today as an alternative to purchasingadditional instrument sets or to save time when sterile instruments are requiredon short notice. Flash sterilization is, in some respects, an orphan process. Noone wants to be responsible for recommending its routine use in the OR.Nevertheless, flash is widely used in the routine processing of devices withinthe OR. Personnel carrying out this flash sterilization process have otherduties which are often considered to be more important than something so mundaneas properly carrying out the complete, disciplined, multi-step process ofdecontamination and preparation of the instruments before sterilization. Suchattention to the details of sterilization is left to the personnel in CSPD forall other goods. Users tend to forget that the flash sterilization cycle isshort in time--often, an assumption is made that no barriers or minimum barriersto sterilant penetration are present in devices during a flash cycle. That maynot be the case if the users have not paid careful attention to the reprocessingdetails required for flash sterilization. The instrument manufacturer may nothave considered the particular requirements of flash sterilization when deemingthe instrument as a reusable medical device. Since reprocessing orresterilization using flash is not a primary duty of those carrying out theprocess, they may be distracted by higher priorities from properly and correctlycarrying out all of the steps necessary for a successful outcome. OR nurses andtechnicians are often overburdened with duties.
The exposure times recommended by sterilizer manufacturers are demonstratedto be effective when used strictly in accordance with their writtenrecommendations. However, the sterilizer manufacturer assumes no responsibilityfor the preparation of the items to be sterilized, nor their proper placementwithin a tray or container, nor of the tray's placement within the sterilizingchamber. Nor do they assume any responsibility for the transport of the items tothe point of use. Sterilizer manufacturers historically have considered flashsterilization as an act to be done under exceptional conditions. That is, thatflash sterilization will be conducted only when a critical or emergencysituation exists (i.e., the dropped instrument).
This assumption is erroneous. Rather than being the exception, flashsterilization is the rule in many ORs. (In 1999, one hospital's staff memberssaid they carried out more than 33,000 flash procedures.4)
Consider that most hospital steam sterilizers are manufactured to meet therequirements of ANSI/AAMI ST8 Hospital Steam Sterilizers.2 ThisAmerican National Standard was developed by the Association for the Advancementof Medical Instrumentation (AAMI) as a consensus standard reflecting the bestinformation available and agreed upon by a committee of members representingusers, producers, and general interest categories of expertise. As such, thestandard is accepted by the US Food and Drug Administration (FDA) as a means ofsterilizer manufacturers' compliance to special controls (in this case aconsensus standard) applicable to Class II medical devices. A hospital steamsterilizer is a Class II medical device. The FDA requires premarket notification[510(k)] before a hospital steam sterilizer can be introduced to the market.Part of the information required of the manufacturer for conformance to ST8 isthe documentation of biological testing results specified in the standard. Notethat ANSI/AAMI ST8 currently does not require testing of a "flash" orunwrapped goods cycle.
The standard requires and specifies the testing of three types of loads. Theyare: the fabric test pack, liquid loads of three one-liter flasks (ifapplicable), and a wrapped instrument test pack. Also note that there iscurrently no requirement in the standard for a manufacturer to demonstrate aflash cycle. However, most steam sterilizer manufacturers do make available arecommendation for a flash cycle based on testing they have done. That testingdefines an unwrapped (or a single wrapper with special instructions) load ofspecified size to establish a cycle of sufficient lethality to provide asterility assurance level of 10-6. That testing may be for asimulated small load or even for a single item. Caution should be exercised bythe user, since some manufacturers may not have test data to support theprocessing of large tray loads such as those typical in orthopedic instrumentprocessing. The user should strictly adhere to the sterilizer manufacturer'swritten recommendations with respect to that load. If the manufacturer has notprovided such documentation, ask for it. In any event, the user should validatethrough a performance qualification that the loads being processed are actuallybeing subjected to sterilization condition in the configuration presented withinthe sterilizer chamber. Any significant changes to that load should be carefullyvalidated to ensure that the flash process used will sterilize.
The steam sterilizers available and used today for flash sterilization inhospitals today are designed to be efficient, reliable, and effective whenoperated within the manufacturer's recommendations. But, as flash sterilizersare used and misused, their use may not represent good sterilization practice asunderstood by the experts in the field--those responsible for sterilization inCSPD. There is hope for the user in that AAMI has also provided a recommendedpractice that covers flash sterilization in hospitals. ANSI/AAMI ST37 FlashSterilization: Steam Sterilization of Patient Care Items for Immediate Use1was developed to answer this need. This recommended practice concentrates onwhat is needed to ensure that flash sterilization is safe and effective. Workpractices are described reflecting the complete process of sterilization as aguide to those not having a sterilization background. The physical layout of thefacility is considered to provide reference for those planning revision to oldor design of new facilities. There is also discussion regarding procedures toassure aseptic transfer of sterilized items from the flash sterilizer to thepoint of use in the sterile field. Appreciate that a recommended practice suchas ST37 should serve as a guide for those interested in moving towardperformance objectives intended to bring the practice of flash sterilizationmore closely into agreement with those practices generally accepted for thesterilization of reusable medical devices.
When considering any medical/surgical instrument as a reusable device, onelooks to the manufacturer of the instrument for advice and instructions on howto reprocess that item. That information is especially important whencontemplating an instrument to be a candidate for flash sterilization. The flashsterilization process is a multi-step process that requires meticulous attentionto detail for success. Failure to decontaminate and clean an instrument properlycan defeat the process. The instrument manufacturer is obligated to provide theuser with at least one method of reprocessing if the device is labeled forreuse. The method described, however, may not be compatible with your flashsterilization procedures. The proper disassembly of complex devices is one ofthe most difficult manufacturer recommendations to meet for users. Writtenprocedures are frequently not specific enough to ensure all instruments areconsistently and properly prepared for flash sterilization.
Of particular concern is the sterilization of implantables. Flashsterilization of implantables is not recommended.3 Orthopedic setsare typically one of the most frequently flash sterilized sets of instruments.The items necessitating flash sterilization in those orthopedic sets are itemsthat are implanted in the patient (i.e., screws).
Careful analysis of items being flash sterilized can potentially identifyalternative solutions that may reduce the number of flash sterilization cyclesbeing used. For example, if information is collected that accurately reflectsthe items being added to a set that then requires flash sterilization, thereasons for using flash sterilization can be identified. The follow-up actionrequired is to acquire enough of those items to eliminate the need for flashcycles.
In addition to providing written documentation of work practices for users toensure proper cleaning and decontamination, inspection, and the arrangement andpackaging of instruments in trays to be sterilized, it is recommended that anyOR conducting flash sterilization start tracking by cycle what trays wereprocessed and why the flash cycle was needed. This analysis will serve todocument the specific needs that must be met to reduce the number of flashcycles being run. By recording the reason for performing the flash cycle, adatabase may be developed that will aid in establishing a rationale foreliminating the need for the flash cycle in the first place. Often, a smallinvestment in purchasing additional individual single-use items may result in asignificant reduction in the number of flash cycles being carried out. If thoseflash cycles being eliminated are cycles containing implants where biologicalmonitoring is required, a significant cost reduction can be realized over time.Anecdotally, the hospital referred to earlier used this technique to reduce thenumber of flash cycles from about 33,000 per annum to less than 22,000 in oneyear's time.4
Normally OR personnel are too busy to record information concerning their useof flash sterilization. But they certainly would be happy if they didn't have torun one of every three flash sterilization they run today. OR managers are welladvised to look at means of eliminating activities such as flash sterilizationsince that is the only true means of eliminating labor costs.
Charles O Hancock is the president of Charles O. Hancock Associates, Inc.in Fairport, NY.
To receive a copy of the ANSI/AAMI ST8 visit www.fda.gov/
For a complete list of references, visit www.infectioncontroltoday.comFor a complete list of references click here