Sterilization Q&A
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Asked March 22nd, 2009
The new ANSI/AAMI/ISO 10993-7 should be published in 2009 and includes dramatic reductions in residuals resulting from the EtO sterilization process. Meeting the requirements of the new standard will depend on which EtO residual (EtO, EG, EC) is elevated in your product. EtO residual can only be reduced by 1) reducing the amount of gas to which the product is exposed, 2) reducing the amount of time the product is exposed to the gas, 3) adding air or nitrogen washes at the end of the cycle to remove the residuals, and 4) increasing aeration time and temperature after sterilization. If EtO residual is not extremely over the maximum allowed for the device, then typically nitrogen washes can be added at the end of the cycle to remove the excess residual, and additional aeration time is not required. If the product is porous or tends to hold EtO, then it may be necessary to change product components, develop a new cycle, or, in extreme circumstances, convert the product to radiation sterilization. In the case of EC residual, nothing in the EtO cycle will contribute greatly to reducing this residual. Typically what is causing elevated EC levels is the product’s exposure to chlorine or salt treatment prior to EtO sterilization, e.g., chlorine washing of textile products. If EC cannot be reduced to meet the new required levels of your product, then the manufacturer needs to examine either 1) pretreatment of the product with radiation prior to EtO sterilization instead of chlorine treatment or 2) removal of the processing step that is introducing the chlorine. The new standard or any standard associated with sterilization using EtO can be purchased at www.aami.org.



