FDA meeting examines potential solution to sterilization facility closures

The Food and Drug Administration should study potential alternatives to ethylene oxide for sterilizing medical devices, but a solution could be at least a decade away, experts told an FDA advisory panel at a meeting this week on the issue. FDA last month alerted the public to growing concern about the potential for medical device shortages as facilities that sterilize devices using ethylene oxide face the threat of closure in certain states. Currently, about 50% of medical devices are sterilized using ethylene oxide. The agency has 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.