The U.S. FDA announces that it has been “closely monitoring” how the closures of certain large-scale sterilization facilities that use ethylene oxide gas to sterilize medical devices prior to their use will impact the healthcare sector. Specifically, 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 impair operations.
“We have been working diligently with impacted device manufacturers and healthcare delivery organizations to ensure that they are aware of these developments and preparing to minimize adverse effects on patients whose care could be negatively affected if medical devices sterilized at these large facilities were not accessible,” Acting FDA Commissioner Norman E. “Ned” Sharpless, MD, said in a statement.
Although medical devices can be sterilized by several methods, ethylene oxide is a well-established and scientifically proven method of preventing harmful microorganisms from reproducing and causing infections. More than 20 billion devices sold in the U.S. every year are sterilized with ethylene oxide, accounting for approximately 50% of devices that require sterilization.
Moreover, medical devices made from certain polymers (such as plastic or resin), metals, or glass—or devices that have multiple layers of packaging or hard-to-reach crevices—are likely to be sterilized with ethylene oxide to avoid product damage during the process. “Without adequate availability of ethylene oxide sterilization, we anticipate a national shortage of these devices and other critical devices including feeding tube devices used in neonatal intensive care units, drug-eluting cardiac stents, catheters, shunts and other implantable devices,” Sharpless adds.
Currently, there are no readily available processes or facilities that can serve as viable alternatives to those that use ethylene oxide to sterilize these devices. In short, Sharpless says, “This method is critical to our healthcare system and to the continued availability of safe, effective, and high-quality medical devices.”
Further, the FDA is urging medical device manufacturers that use ethylene oxide facilities to assess their inventory for any potential downstream impacts of sterilization facility closures on their product distribution. “We are committed to working with manufacturers to look for alternative sterilization options,” Sharpless adds.
The agency is also encouraging healthcare facilities to assess critical items in their inventory that undergo contract terminal sterilization via ethylene oxide prior to shipping and reach out to the FDA to help identify potential substitute devices. Hospitals and other healthcare delivery organizations should also work with their purchasing departments, group purchasing organizations and distributors, as appropriate, to help obtain products needed for patient care, Sharpless maintains.
“We also encourage device manufacturers and healthcare providers to provide us with information on potential supply issues. We have a device shortages mailbox so that any user, patient, manufacturer, or organization within the supply chain that is aware of a delay in distribution of new product, and/or anticipates a shortage, can notify us,” Sharpless says.
Time, he adds, is of the essence. “It’s never too early to contact us—the sooner we are aware of a potential shortage, the better we can assist in proactively developing a plan to mitigate its effects on patient care.”