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Association for the Advancement of Medical Instrumentation _AAMI_ by malj

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									 Association for the Advancement of Medical Instrumentation (AAMI)
   Steam sterilization and sterility assurance in health care facilities
                        ANSI/AAMI ST46: 2002
        Recommended Practices for Monitoring Implant Loads
The AAMI ST46 recommended practice, Section 7.4.3.3 Frequency of use of biological
indicators states the frequency of routinely using biological indicator (BI) test
packs/process challenge devices (PCDs) (p. 44):
        “Biological indicator test packs also should be used routinely in sterilization loads
        at least weekly, but preferably every day that the sterilizer is in use (7.5.4).

       Each load containing wrapped/packaged implantable devices should be monitored
       with a BI challenge test pack and whenever possible, quarantined until the results
       of the BI testing (early readout or spore growth) are available. When documented
       medical exceptions dictate (e.g., the need for trauma-related orthopedic
       screw/plate sets), it may be necessary to release an implantable device before the
       BI results (early readout or spore growth) are known. As with all cycles, the
       sterilizer operator should review the sterilizer chart/printout and the results of
       other indicators that have been used to monitor the sterilization process (7.7). It
       should be documented that the device was released without the results of the BI
       being known. See annex C for examples of an implant log and exception form.”

In addition to using biological indicators to release loads, the AAMI ST46 recommended
practice document states in Sections 7.4.2.3 Using chemical indicators (p. 43):
        “Multiple-parameter CIs and integrating CIs provide more information about the
        process than do single-parameter indicators. The results of Class 5 integrating
        indicators may serve as the basis for the release of processed items, excluding
        implants. These integrating indicators must be used within an appropriate
        challenge test pack. Using Class 5 integrating indicators for this purpose does not
        replace the use of BIs as described in 7.4.3.”

								
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