7 questions about ethylene oxide as FDA panel convenes

Read the full story at MedTech Dive.

Regulators from public health agencies, medical device manufacturers and expert physicians are gathering starting Wednesday at a two-day meeting to discuss how to address challenges with ethylene oxide, a carcinogenic gas used to sterilize more than 50% of medical devices.

The FDA advisory committee meeting comes nearly a year after former Illinois Attorney General Lisa Madigan and DuPage County State’s Attorney Robert Berlin filed a lawsuit against Sterigenics alleging ethylene oxide emissions at its Willowbrook plant put public health at risk.

The big questions: What’s the potential impact of reducing, eliminating or replacing ethylene oxide sterilization on the medical device supply chain, and what can FDA do to prevent shortages of critical devices used by hospitals and other healthcare providers across the country.

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