If the retest confirms a positive spore growth, then the sterilizer must remain out of service and all instruments that were sterilized by that machine must be recalled from use and re-sterilized through a different sterilizer to confirm that they are safe for patient care. Remember to document both the failed test and the passing retest in this scenario. Twp test strips and one control strip are provided for users to spore test multiple locations within the sterilizer chamber. This system provides 3rd party legal documentation of sterilization from the largest sterilizer testing laboratory in North America. Most failed spore tests are due to operator error, so a passed retest confirms that the sterilizer is safe to use. Autoclave Spore Test By SPS Medical PP-052. Learn more about proper placement of spore vials inside your sterilizer. Final results are known after only 24 hours of incubation in any compatible dry-block incubator operating at 5560☌. This system gives clear, easy-to-interpret results for monitoring the effectiveness of the sterilization process. The sterilizer must be removed from service until you get a passing result from the retest. In Office Biological Monitoring (Spore Testing) Be sure your sterilizer is functioning properly by performing biological monitoring at least once weekly following CDC recommendations. An in-office biological indicator (BI) system certified for use with all steam sterilization cycles. Also, AAMI TIR34:2014/(R)2017, Water for the reprocessing of medical devices.
If a positive test is reported on a sterilizer, immediately retest the sterilizer using the same cycle that produced the positive result. Please see ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities for more information, Section 3.3.3.1 and Annex M. In the case of in-office biological monitoring using the ConFirm 10 or 24 hour product, recommended record keeping includes a log of the sterilization date, the staff member who conducted the procedure, incubation times and the final results for both the test and. Remove any sterilizer with a positive test Written documentation is key to providing proof of sterilization efficacy and provides evidence of testing in the event of an audit.
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