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Medical Devices / Regulatory Affairs

FDA Takes Aim at Potential Device Shortages After Sterilizer Shuts Down

March 28, 2019
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A large Illinois contract sterilization facility has closed its doors, prompting the FDA to take actions to address possible device shortages.

After it learned that the EPA ordered Sterigenics’ Willowbrook, Illinois facility to cease sterilization of hundreds of medical devices, the FDA reached out to devicemakers that contracted the sterilizer’s services.

“We are working directly with manufacturers, as needed, to help transition to another sterilization site or sterilization method,” the agency said, adding that it’s also looking at making devices available from other sources if necessary.

The FDA urged device manufacturers that worked with the facility to begin assessing “any potential downstream impact” of the closures on device distribution to health care facilities.

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