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EPA Considers Reporting Requirements for EtO Usage

Boston Scientific and Sterigenics are potential targets for the new sterilization reporting protocol.

The EPA is under pressure to decrease ethylene oxide (EtO) usage in sterilization facilities. However, the FDA has warned that facility closures will lead to medical device shortages. According to a recent MedTechDive article, the Environmental Protection Agency may soon require reporting on usage for sterilization at manufacturing facilities.

Facilities run by Boston Scientific and Sterigenics were specifically called out, but the EPA wrote to operators of 31 medical device sterilization facilities outlining its plan and requesting information. The facilities were chosen based on their EtO use and proximity to populous areas.

For more on EtO, read our recent article, Safety Factors for Ethylene Oxide Sterilization: Patient, Worker, and Environment.

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