Your sterilizer might be free of obvious mechanical malfunction, and you might also be certain the sterilizing agent is penetrating the package and reaching the instruments inside. It appears you've achieved the necessary physical and chemical conditions for sterilization.
That still doesn't mean your autoclave is properly sterilizing your instruments!
Biological monitoring manages sterilization with the use of bacterial spores. Biological Indicators (BIs) are considered the highest level of sterility assurance because they actually test the sterilizer's ability to kill specific strains of highly resistant organisms. Commercially available BIs are non-pathogenic (harmless) and are specific for the type of sterilization process being monitored.
Of the three processes available to monitor sterilization, only biological monitoring directly monitors the lethality of a given sterilization process, according to the CDC.¹ If a sterilizer is used frequently (e.g., several loads per day), daily use of biological indicators allows earlier discovery of equipment malfunctions or procedural errors—minimizing the extent of patient surveillance and product recall needed in the event of a positive biological indicator.
According to the CDC, as well as the American National Standards Institute (ANSI) and Association for the Advancement of Medical Instrumentation (AAMI), steam sterilizers should be monitored at least weekly, preferably every day the sterilizer is run.
For a handy reference guide, download our in-office biological indicator for monitoring steam processes poster.
Biological indicators available from Henry Schein include:
Mail-in service includes: three bacterial spore test strips (two test strips and one control strip) per test package. Postage is prepaid and culturing service is included. Monitors all sterilizers including steam, chemical vapor, dry heat, and EtO. Third-party documentation serves as tangible, legal document where proof of sterility testing must be provided. Immediate and confidential notification of test failures. Test results available electronically.
Product Details & Ordering
In-office system for testing steam sterilizers. Results in 24 to 48 hours. Simply process vial in a normal sterilizer cycle then activate vial, incubate, and record results. If any spore survive process, vital medium will turn yellow. Holds up to 14 indicators.
Disposable pack used to evaluate the efficacy of air removal and steam penetration in prevacuum steam sanitizers. Includes frequency of use, instructions for use and storage/shelf-life information preprinted on the box for ease of use and staff training. Lead-fee and easy to interpret.
The MaxiTest Steam BI Test Pack with MaxiTest Class 5 integrator is indicated for use in routine monitoring and sterilizer qualification testing. Allows users to immediately release processed loads per ANSI/AAMI standards. Steam sterilizers should be monitored at least weekly, preferably every day the sterilizer is run.
Learn more about Mechanical Monitoring
Learn more about Chemical Monitoring
Learn more about sterilizers from Ritter by Midmark
Learn more about sterilizers from Tuttnauer
Repair your current sterilizer with Henry Schein's affordable ProRepair services.
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Return to our main sterilization page to learn about monitoring best practices.