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MEDICAL REGULATIONS

Best practices established by regulatory agencies state that monitoring of sterilizers using biological indicators (BI’s) should be done Weekly, if not daily (or before each day the sterilizer is used).  ATS, Inc. recommends that every sterilizer in the medical field should be monitored at least Weekly.  Sterilizer operators should use Class 5 Integrators with each cycle between the BI testing.  (Rationale:  If a Positive BI test occurs, there is no more than 5 days of sterilized items that are in question that were processed since the last Negative BI test report).

Some of the recommended practices are listed here starting with the Federal governments CDC recommendations.

CDC (Center for Disease Control and Prevention)  www.cdc.gov

"All sterilizers should be monitored at least once a week with commercial preparations of spores intended specifically for the type of sterilizer."

(from Gamer JS, Favero MS. CDC guideline for hand washing and Hospital environment control 1985. Infection Control 1986; 7:231-43)  

AAMI (Association for the Advancement of Medical Instrumentation)  www.aami.org

Biological indicators should be used within PCDs for routine sterilizer efficacy monitoring at least weekly, but preferably every day that the sterilizer is in use.” (from ANSI/AAMI  ST79:2006, Section 10.5.3.2)

AORN (Association of Perioperative Registered Nurses) www.aorn.org

“For routine monitoring should be used weekly, and as needed; each load of implantables.”  (from Recommended Practices, Sterilization & Disinfection, 1987)

OSAP (Organization for Safety & Asepsis Procedures)  www.osap.org

“The use and functioning of heat sterilizers should be biologically monitored at least weekly, or more often if the practice demands it, with appropriate spore tests.”  (from Infection Control in Dentistry Guidelines, September 1997)

VA (Veteran’s Administration)

“…must be sterilizer monitored no less than weekly, each load of implantables or intravascular materials, following major sterilizer repairs, new products or packaging material.”  (from VA Manual G1, MP-2, Sub-chapter E, Change 159, June 22, 1083)

AAP (American Academy of Pediatrics)   www.aap.org

Biological indicators are necessary to ensure sterility.  A variety of indicator systems are available.  The procedure recommended by the manufacturer to document sterility should be done at least weekly and results should be recorded.”  (from June 2000 Policy Statement)

 

GLOSSARY OF TERMS USED: