Embracing, Expanding Sterilization Standards Endorsed in FDA Webinar

A week following the EPA’s announced new rules for facilities emitting cancer-causing ethylene oxide (EtO), FDA officials urged consensus standards be developed and broadly accepted for medical device sterilization protocols and premarket submissions.

In a webinar last week, virtual attendees watched presentations from CDRH’s Lisa Simone and Arun Le of the Office of Readiness and Response, and Ryan Ortega of the Office of Product Evaluation and Quality describing the role of the agency’s Division of Standards and Conformity Assessment in recognizing FDA-recognized consensus standards.

The FDA town hall was the fourth in a series devoted to the use of EtO for sterilization of reusable medical devices. In a January town hall meeting, the FDA admitted there were no adequate substitutes for EtO, estimating that half of all medical devices — around 20 billion — are sterilized with the chemical annually.

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