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Sterilization Facility Shutdowns Could Spell Medical Device Shortage; FDA Urges Firms To Assess 'Downstream Impacts'

US FDA says the closing of at least two sterilization facilities due to environmental hazard concerns could lead to a device shortage. The agency is working with stakeholders to come up with mitigating strategies, including finding new sterilization methods and facilities. The issue has prompted FDA to plan a public hearing later in the year to strategize on solutions and an innovation challenge to come up with new sterilization methods. In the meantime, to help industry understand its latest thinking on ethylene oxide for sterilization use, FDA has launched a website to provide resources and updates, including the latest sterilization facility closures.

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The closing of two facilities that use ethylene oxide to sterilize medical devices risks creating a shortage of products, according to US FDA. The agency is working with industry and other stakeholders to figure out what the full impact will be and is seeking to come up with solutions to prevent any potential shortages.

In February, the Illinois Environmental Protection Agency closed a sterilization facility run by Sterigenics because it exceeded the limits for how much ethylene oxide is acceptable to release into the...

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