Boston Scientific, Sterigenics potential targets of EPA ethylene oxide reporting requirements

Read the full story at MedTechDive.

The Environmental Protection Agency is considering applying ethylene oxide (EtO) reporting requirements to facilities run by companies including Boston Scientific and Sterigenics.

EPA has written to the operators of 31 medical device sterilization facilities to outline its plans and request information to inform its final decision. The agency chose the facilities based on the amount of EtO they are estimated to use and other factors such as their proximity to population centers.

A final decision is due after the 30-day comment period. If EPA puts reporting requirements on some or all of the facilities, it will advance a multi-year effort to balance the risks of the carcinogen against the benefits it brings in the sterilization of medical devices. The move follows an Office of Inspector General report in May that advised EPA to conduct a fresh review of residual cancer risks from EtO emissions.

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