Current Regulatory Landscape for EO Residue Levels in Medical Devices

One of many crucial steps a single-use medical device takes on its journey from concept to commercial product is sterilization. Ethylene oxide gas sterilization, in particular, is one of the most efficient and effective ways of deactivating bacteria and other potentially dangerous living microbes from medical devices; however, manufacturers must take care to control and minimize ethylene oxide residuals remaining in devices after sterilization has taken place.

Ethylene oxide gas remains a popular choice for terminal sterilization because of its effectiveness and its suitability for use with plastic and other heat-sensitive device materials.

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