FDA: Sterilization facility closures could prompt future device shortages

The Food and Drug Administration today alerted the public to growing concern about the potential for medical device shortages as facilities that sterilize devices using ethylene oxide close. “Since we first became aware of this issue earlier this year, we have continued to focus intently on addressing the immediate impacts of these closures and potential closures to help ensure patients can have access to the safe, effective, and high-quality medical devices they need today,” said Acting FDA Commissioner Ned Sharpless, M.D. “We continue to communicate directly with manufacturers and monitor the supply of devices sterilized in facilities that have closed or that may close, paying special attention to life-saving, life-sustaining, and other critical devices.” He urged health care providers and medical device makers to assess their supplies of affected devices and report anticipated shortages or distribution delays by email to deviceshortages@fda.hhs.gov.