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New AAMI Report Offers Guidance on EtO Sterilization

The Association for the Advancement of Medical Instrumentation (AAMI; Arlington, VA) has released an updated technical information report (TIR) offering guidance on developing sterilization cycles for ethylene oxide (EtO or EO) sterilization. Intended primarily for sterilization personnel involved in EtO sterilization cycles, TIR15 contains information on how to create a safe and effective cycle, including details on conditioning and flammability curves to ensure safety. Titled "Physical Aspects of Ethylene Oxide Sterilization," the report has been revised to complement the newly updated ANSI/AAMI/ISO 11135-1:2007 standard. "The TIR gives guidance related to the physical aspects of EO rather than the microbiological ones," says Gerry O'Dell, co-chair of AAMI's Industrial Ethylene Oxide Sterilization Working Group and president of Gerry O'Dell Consulting. Philip Cogdill, O'Dell's fellow co-chair and director of corporate sterilization and microbiology at Boston Scientific, notes that the document includes practical and technical advice on what to look for in all aspects of the sterilization process. The document's new flammability curve helps ensure a safe sterilization cycle. "A flammability curve is very helpful in making sure that cycles are designed in such a way that the EO environment will not have a composition of the mixtures of EO-air-diluent ratios in the combustible range," Cogdill says. The report also offers guidance on how to develop a sterilization cycle, including the best type of condition method. "Conditioning occurs during the sterilization cycle and is the phase where you introduce moisture and elevate the temperature of the product for sterilization," O'Dell says. "TIR15 gives guidance on how to use the different methods and to calculate what type of humidity levels you will obtain in that process." More information on the report can be obtained directly from AAMI.

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