There will likely be a national shortage of medical devices—including CV tools like stents, shunts and catheters—in the near future, according to the FDA.
In a statement issued Oct. 25 on behalf of the agency, FDA Acting Commissioner of Food and Drugs Norman E. Sharpless, MD, warned of an impending device shortage due to the closure of “certain large-scale sterilization facilities” in the U.S. These facilities use ethylene oxide, a flammable, colorless gas, to sterilize a variety of medical devices prior to their use.
To date, one Sterigenics ethylene oxide sterilization facility in Illinois has shuttered its doors and one in Georgia has been closed temporarily. Another large Becton Dickinson sterilization facility in Georgia is facing possible closure.
“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 of patients whose care could be negatively affected if medical devices sterilized at these large facilities were not accessible,” Sharpless wrote in his statement. “Medical devices that are sterilized to remove potentially harmful germs and other microorganisms prior to use are critical to our healthcare system and a shortage—especially of life-saving, life-sustaining, or other critical devices—can be a detriment to public health.”
Ethylene oxide is the most common method of medical device sterilization in the U.S., Sharpless explained, responsible for sterilizing some 20 billion devices in the country each year. Devices made from certain polymers, like plastic or resin, as well as those made from metal or glass, are likely to undergo sterilization with ethylene oxide to avoid product damage during the cleaning process. Such devices include surgical kits for cardiac surgery, feeding tube devices, drug-eluting cardiac stents, shunts, catheters and other implants.
Sharpless underlined the fact that there are no readily available alternatives to these devices, making ethylene oxide sterilization “critical to our healthcare system and to the continued availability of safe, effective and high-quality medical devices.” He urged healthcare facilities and device manufacturers alike to assess their own processes and inventory for inconsistencies.
Ethylene oxide in the environment
Ethylene oxide might be a key component in medical device sterilization, but it’s faced a fair amount of pushback on the state level. In February, the Illinois Environmental Protection Agency (EPA) issued a state EPA order to stop the Sterigenics in Willowbrook, Ill., from using the substance, citing higher-than-acceptable levels of ethylene oxide emissions in the surrounding area.
The Willowbrook closure resulted in a temporary shortage of pediatric breathing tubes, and Sharpless said the FDA is worried that “additional facility closures could severely impact the supply of sterile medical devices to healthcare delivery organizations that depend on those devices to take care of patients.”
The EPA may have its eye on ethylene oxide as a potential pollutant, but AdvaMed—the Advanced Medical Technology Association—maintains that ethylene oxide concentrations are safe in the areas surrounding device sterilization plants.
“We absolutely understand why those who live around these plants are deeply concerned based on what they’ve heard and read,” AdvaMed President and CEO Scott Whitaker said in a statement Oct. 25. “But leading toxicologists and epidemiologists are certain that media reports have been misleading, and that the communities surrounding these plants are safe. These experts need to be a much bigger part of the conversation within these neighborhoods and with policymakers.”
Still, Whitaker acknowledged the conversation about the risk of ethylene oxide sterilization plants as an important one, noting that “critical medical devices might not make it into doctors’ and surgeons’ hands if we aren’t careful.”
The FDA has scheduled a public advisory committee meeting for Nov. 6 and 7 in Gaithersburg, Md., to discuss best practices in medical device sterilization.
After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.