CDRH Warns of Potential Medical Device Shortages Following Sterilizer’s Suspension

March 13, 2019

CDRH warned of potential device shortages, following an EPA order to stop medical equipment sterilizer Sterigenics’ Willbrook, Illinois facility from sterilizing products with ethylene oxide.

The order bars the facility from beginning any new sterilization cycles using ethylene oxide, which gave off emissions that the Illinois EPA feared would “present an imminent and substantial endangerment to residents and off-site workers” located near the facility.

 “At this time, the FDA believes that more than 100 manufacturers and hundreds of devices may be affected,” the agency said.

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