What are standards groups recommended practice for monitoring and releasing loads with Biological Indicators, Class 5 Integrating Indicators, and Class 6 Emulating Indicators?
Take a few moments to learn what each of these organizations state concerning monitoring and load release
Association for the Advancement of Medical Instrumentation (AAMI)
AAMI ST79 recommends weekly preferably daily routine sterilizer efficacy testing and sterilizer qualification testing with a biological indicator process challenge device (BI PCD) (10.5.3.2).3
Additionally, AAMI ST79 recommends all loads containing implants be monitored with a PCD that contains both a BI and a Class 5 integrating indicator (10.6.1). Loads containing implants should be quarantined until the results of the BI are known unless a documented emergency situation exists (10.6.3). Biological indicators also should be used for periodic quality assurance testing of representative samples of actual products being sterilized (10.5.3.2).3
According to AAMI ST79 recommended practice includes using a Class 4 or Class 5 CI inside each package (Section 10.5.2.2.2 Internal Chemical Indicators). AAMI ST79 (10.5.3.2) states that BI's are the only sterilization process monitoring device that provides a direct measure of the lethality of the process.
3 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities (ANSI/AAMI ST79). Association for the Advancement of Medical Instrumentation, 2006.
*The 2008 update will only include the definition for Class 6 Emulating Indicators. No use or application will be provided in this update.
Association of Perioperative Registered Nurses (AORN)
AORN Perioperative Standards and Recommended Practices, 2008 Edition
Recommendation IV
Use of Flash Sterilization
IV.c.3. Biological (BI) and chemical indicators should be used to monitor sterilizer efficacy and assess compliance of monitoring-standards established for gravity-displacement and dynamic air-removal sterilizers. Class 5 integrating indicators should be used within each sterilizer container or tray.1
IV.h 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 run with the load.1, 2 (PNDS: 170,198)
Recommendation XVI
Quality
XVI.h.2. Steam sterilizers: Geobacillus stearothermophilus biological indicators should be used for routine load release, routine sterilizer efficacy monitoring, sterilizer qualification testing, and periodic quality assurance testing. Routine sterilizer efficacy monitoring should be done weekly preferably daily as follows:
Each load containing an implantable device should be monitored with a BI and quarantined until the results of the BI testing are available, and One BI PCD should be run in three consecutive empty cycles for sterilizer 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 mode, should be tested1
1Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79:2006 - Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. Arlington, VA
2 Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. [Special Report]. Infection Control and Hospital Epidemiology. 1999; 20:250-278. Available at http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/SSI.pdf. October 26, 2007.
Centers for Disease Control and Prevention (CDC)
http://www.cdc.gov/ncidod/dhqp/disinfection.html
"Microbiological monitoring of steam sterilizers is recommended at least once a week with commercial preparations of spores of Bacillus stearothermophilus (a microorganism having spores that are particularly resistant to moist heat, thus assuring a wide margin of safety)."
"Implantable items, such as orthopedic devices, require special handling before and during sterilization; thus, packs containing implantable objects need to be clearly labeled so they will be appropriately processed. To guarantee a wide margin of safety, it is recommended that each load of such items be tested with a spore test and that the sterilized item not be released for use until the spore test is negative… "
