FDA’s Growing Concern on Device Sterilization
FDA is growing concerned over recent closures of certain large-scale sterilization facilities that use ethylene oxide to sterilize medical devices prior to their use. “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,” a 10/25 FDA notice says.
There are several methods used to sterilize medical devices, but ethylene oxide is the most common, well-established and scientifically-proven, FDA notes. “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,” it explains. “These include surgical kits used in emergency procedures such as emergency Caesarean sections ("C-sections") and in routine procedures such as cardiac surgery and hip or knee replacement surgeries. 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.”
Some of the sterilization facility closures were due to concerns associated with release of ethylene oxide into the environment if emissions were to occur at unsafe levels. “Because the number of ethylene oxide contract sterilization facilities in the U.S. is limited, we are very concerned that additional facility closures could severely impact the supply of sterile medical devices to health care delivery organizations that depend on those devices to take care of patients,” FDA says. “The impact resulting from closure of these and perhaps more facilities will be difficult to reverse, and ultimately could result in years of spot or nationwide shortages of critical medical devices, which could compromise patient care.”
In light of these concerns, FDA is urging device makers that use ethylene oxide facilities to assess their inventory for any future impacts of sterilization facility closures on their product distribution. The agency also says device firms should report product supply issues.
Meanwhile, FDA recently announced two new innovation challenges to encourage ideas and novel solutions for improving sterilization processes. “This includes a call to identify new or alternative sterilization methods and technologies that are alternatives to those that use ethylene oxide, and another to develop new strategies to reduce ethylene oxide emissions,” it says. And next month, a public advisory committee meeting is planned to discuss how best to encourage innovation in medical device sterilization.