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probably does not indicate sterilization malfunction . Iters ether 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 service , and all records reviewed of chemical and mechanical monitoring since the last negative BI test . Also , sterilizer operating procedures should be reviews , including packaging separation , and incorrect or excessive packaging material are all common reasons for a positive BI in the absence of Mechanical failure of the sterilization unit . A second monitored sterilizer in the office can be used , or a loaner from a sales or repair company obtained , to minimize office disruption while waiting for the repeat Bl . 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 been confirmed as performing correctly, the sterilizer should remain out of service until it has been inspected , repaired , and re challenged with BI tests in three consecutive 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 which 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 satisfactory 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 known . This approach is considered conservative because the margin of safety in steam sterilization is sufficient enough that the infection risk , associated with items in a load indicating spare growth , is minimal , particularly if the item was properly cleaned and the temperature was achieved ( e . g . as demonstrated by chemical indicator or temperature chart ) . published studies are not available that document disease transmission through a non retrieved surgical instrument after a steam sterilization cycle with a positive biological indicator. This more conservative approach should always be used for sterilization methods other than steam ( e . g . dry heat , unsaturated chemical vapor, ETO , or hydrogen peroxide gas plasma ) . S . Commercial l i t Manufacturers . Dynamic black ink , color ink hawink T. Permanent Cosmetic r Manufacturer : Wireless tattoo machine pen , SAIKO 'YA ® Service Animals . Only service animals are allowed in the procedure room , and decontamination and sterilization areas as defined by the federal Americans with Disabilities Act .