In our top 10 of 2019, we examine how the interruptions and closures of ETO sterilization facilities may impact medical device availability (article here). The FDA comments included some advice to device manufacturers—and a request that facilities don’t hoard devices—and highlighted the need for future innovation in sterilization techniques.
Acting FDA Commissioner Ned Sharpless MD issued an Oct. 25 statement on potential medical device supply chain effects due to interruptions in ethylene oxide (ETO) sterilization services.
“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,” said Sharpless.
Many medical devices are sterilized with ETO, including those used for emergency and routine procedures. Unfortunately, at present, no “readily available processes or facilities” serve as an alternative to ETO sterilization…