Sterilization facility closures may threaten availability of medical devices, FDA cautions

Acting commissioner of the U.S. Food and Drug Administration (FDA) Dr. Ned Sharpless recently released a statement regarding medical device availability following the closure of multiple sterilization facilities.

At least two sterilization facilities have been shut down due to concerns over the potentially unsafe emissions of ethylene oxide, which is used to sterilize medical devices.

“The recent closure of a Sterigenics ethylene oxide sterilization facility in Illinois, the temporary closure of another Sterigenics facility in Georgia, and the potential closure of a large Becton Dickinson sterilization facility in Georgia could affect the availability of some sterile medical devices used by health care delivery organizations and patients,” Sharpless said in the statement.

Though there are other sterilization methods, ethylene oxide is the most common in the U.S.

“In light of the possibility of continued ethylene oxide sterilization facility closures, we are again alerting the public to growing concerns about the future availability of sterile medical devices and impending medical-device shortages,” Sharpless said. “We share the public's objective to reduce over-reliance on ethylene oxide for medical-device sterilization. And therefore, in addition to our shortage mitigation efforts, we have also been addressing the broader need for innovation and improvements to medical device sterilization techniques in general.”