Press Announcements > Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility

Press Announcements > Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility

Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility

A critical focus for the FDA is preventing and mitigating potential medical product shortages. As part of these efforts, we’re taking steps to address potential medical device shortages due to the recent closure of a large sterilization facility in Illinois. We’re working to ensure that safe and effective sterilization of medical devices continues and hospitals, health care providers and patients have access to critical devices.     Earlier this year, the FDA became aware that the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop a contract sterilizer, Sterigenics, from sterilizing medical products and other products with gas called ethylene oxide at their Willowbrook, Illinois facility. The state EPA order was due to the presence of levels of ethylene oxide higher than the EPA found to be acceptable in air around the facility.