March 27, 2019

FDA addresses potential medical device, product shortages amid shutdown of sterilization facility

By: Judy Mathias

Editor’s Note

The Food & Drug Administration on March 26 said it will take steps to address potential medical product and device shortages because of the recent closure of a large contract sterilization facility, Sterigenics (Willowbrook, Illinois).

Earlier this year, the Illinois Environmental Protection Agency issued an order to stop Sterigenics from sterilizing medical products with ethylene oxide because of unacceptable levels of the gas detected in the air around the facility.

The FDA has been closely monitoring the situation and working with device manufacturers to minimize the impact to patients who need access to their products and devices.

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