Challenging the Sterrad 100NX sterilizer with different carrier materials and wrappings under experimental “clean” and “dirty” conditions

BackgroundSterrad sterilizers have been developed for the sterilization of thermolabile materials. The aim of the present study was to challenge the efficacy of this low-temperature hydrogen peroxide–based sterilization system with different carrier materials and wrappings under experimental “clean” and “dirty” conditions.MethodsWe tested the sporocidal effect of the Sterrad 100NX sterilizer (Advanced Sterilization Products, Irvine, CA) on the carrier materials titanium, polyethylene, and polyurethane with single versus 3 wrappings of inoculated carriers. To simulate insufficient cleaning or crystalline residues, carriers were charged with spore inocula containing organic and inorganic burdens.ResultsOur qualitative results show that irrespective of the number of wrappings in the “clean” condition, sterilization by the Sterrad 100NX was equally effective on all 3 carrier materials, reaching a log-10 reduction rate of ≥6 under standard half-cycle conditions. Any additional organic or inorganic challenge significantly impaired the sterilization outcome.ConclusionResults of our current study emphasize the utmost importance of thorough and reliable cleaning of medical devices before being exposed to a subsequent hydrogen peroxide sterilization process. Any institution using this sterilization technology should have a well-established and validated cleaning process and enforce a rigorous quality assurance program for all steps of the presterilization processing of medical devices.