On October 25, 2019, the FDA sounded alarm bells about a potential nationwide shortage of critical medical devices.
The agency was responding to state environmental protection agencies closing facilities that make a gas called ethylene oxide (EtO). The EPA considers EtO to be a carcinogen.
Specifically, the FDA noted recent closures of a Sterigenics EtO 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.
The FDA said it was “closely monitoring” the supply chain effects of closures and potential closures of facilities using EtO to sterilize medical devices prior to their use. The agency said it was “concerned” about the potential medical device shortages that might impact patient care.
Ethylene Oxide Sterilization
EtO, according to the FDA, 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 EtO, accounting for approximately 50% of devices that require sterilization.
The other sterilization methods are gamma (40.5%), e-beam (4.5%) and others such as steam and X-ray (5%).
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 EtO 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.
Device Shortages Anticipated
Without adequate availability of EtO sterilization, the FDA anticipates 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,” stated the FDA.
Clean Air Versus Safe Devices
This isn’t the first time we’ve written about Sterigenics. In December 2018, we reported that Illinois’ two U.S. Senators had asked the EPA to take drastic action to tighten standards and for the FDA to convene a panel to develop alternatives to EtO.
We noted that a 2014 EPA National Air Toxics Assessment (NATA) estimated “that ethylene oxide significantly contributes to potential elevated cancer risks in some census tracts across the U.S.” One of these is the residential neighborhood around the Sterigenics plant. EPA began that monitoring because of the amounts Sterigenics has been allowed to discharge for decades.
EPA officially declared in 2016 that the risk of cancer from EtO is higher than the risk level previously used to set federal regulations.
