As the agency responsible for ensuring the safety and effectiveness of all medical devices, the U.S. Food and Drug Administration has been closely monitoring the supply chain effects of closures and potential closures of certain large-scale sterilization facilities that use a gas called 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. We have been working diligently with impacted device manufacturers and health care 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. Medical devices that are sterilized to remove potentially harmful germs and other microorganisms prior to use are critical to our health care system and a shortage—especially of life-saving, life-sustaining, or other critical devices—can be a detriment to public health. 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.

Although medical devices can be sterilized by several methods, ethylene oxide is the most common method of sterilization of medical devices in the U.S. and 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 percent of devices that require sterilization.

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. 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. It’s important to note at this time 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: this method is critical to our health care system and to the continued availability of safe, effective and high-quality medical devices.

U.S. Healthcare Homepage