Ethylene oxide (EtO) sterilization has been in the news a lot lately, and healthcare has much at stake. According to officials at the U.S. Food and Drug Administration (FDA), approximately 56% of all critical medical devices are sterilized using industrial EtO sterilization. Currently, there are no validated industrial alternatives, so additional closures of EtO processing facilities would have the potential to impair the U.S. healthcare system.
While some state legislators are considering bans on industrial EtO sterilization facilities, healthcare leaders, manufacturers, and FDA have been reviewing options to ensure the availability of sterile medical devices and supplies necessary for patient care.