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R. Negative/Failed Spore Test: If the mechanical (e.g. time, temperature, and pressure) indicators demonstrate that the sterilizer is functioning correctly, a single positive spore test probably does not indicate sterilization malfunction. Items other than the implantable devices do not necessarily need to be recalled; however the spore test should be repeated immediately after correctly loading the sterilizer and using the same cycle that produced the failure. The sterilizer should be removed from ser\ice, and all records reviewed of chemical and mechanical monitoring since the last negative BI test. Also, sterilizer operating procedures should be reviews, includi-ig packaging separation, and incorrect or excessive packaging material are all common reasons for a positive BI in the absence of mechanical failure of tf e sterilization unit. A second monitored sterilizer in the office can be used, or a loarer from a sales or repair company obtained, to minimize office disruption Nh le waiting for the repeat BI. If the repeat test is negative and mechanical monitoring indicates adequate processing, the sterilizer can be put back into service. If the repeat BI test is positive, and packaging, loading, and operating procedures have bee-i confirmed as performing correctly, the sterilizer should remain out of service unti it has been inspected, repaired, and re-challenged with BI tests in three con 3ecutive empty chamber sterilization cycles. When possible, items from suspect loads dating back to the last negative BI should be recalled, rewrapped, and re-sterilized. A more conservative approach has been recommended in wnich any positive spore test is assumed to represent sterilizer malfunction requires that all materials being processed in that sterilizer, dating from the sterilization cycle having the last negative biologic indicator to the next cycle, indicating satisfacto-y biologic indicator results, should be considered non sterile and retrieved, if possible, and reprocessed or help in quarantine until the results of the repeat BI are <nown. This approach is considered conservative because the margin of safety in steam sterilization is sufficient enough that the infection risk, associated wirth items in a load indicating spore growth, is minimal, particularly if the item was properly cleaned and the temperature was achieved (e.g. as demonstrated by che-nical indicator or temperature chart). Published studies are not available that docirrent disease transmission through a non retrieved surgical instrument a-ter a stezm sterilization cycle with a positive biological indicator. This more con3ervative approach should always be used for sterilization methods other :han steEm (e.g. dry heat, unsaturated chemical vapor, ETO, or hydrogen peroxide gas plasma). S. Commercial Ink or Pigment Manufacturers: Dynamic black ink , color ink hawink T. Permanent Cosmetic Machine Name and Manufacturer: Wireless tattoo machine pen, SAIKOYA i