EPA (Environmental Protection Agency) to reconsider emissions norms for medical device sterilizers

EPA Administrator Lee Zeldin announced a review of emissions standards for medical device sterilization facilities as part of a broader deregulation effort. The agency is considering a two-year compliance exemption while it reassesses the rules.

In 2024, the EPA set stricter limits on ethylene oxide (EtO), a carcinogenic gas used to sterilize nearly half of U.S. medical devices, aiming to cut emissions by over 90% and reduce cancer risks. The medtech industry warned that these regulations could disrupt sterilization capacity and cause device shortages.

The EPA granted a two-year compliance period but is now reconsidering the standards. Possible changes would go through a rulemaking process, including public comment. The review reflects ongoing discussions about balancing public health and industry needs.

13-03-2025

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