The Advanced Medical Technology Association (AdvaMed) shared industry concerns over new ethylene oxide (EtO) regulations with President Joe Biden, warning that sterilization facility closures could cause device shortages.
In a new letter to Biden, AdvaMed President and CEO Scott Whitaker said the medtech industry welcomes updated regulations for EtO sterilization facilities and reiterated patient safety warnings.
“With 20 billion medical devices sterilized using EtO each year in the U.S. at about only 100 facilities, the closure of even a small percentage of facilities could harm patient access to health care,” Whitaker wrote. “EtO sterilization is at capacity. With 80 percent of surgical kits alone sterilized using EtO, any shutdown-induced disruption could reverberate from screening to the operating room to post-operative care.”
Those 20 billion products are equal to about half of all medical devices that require sterilization. EtO is the most commonly used sterilization method because it can permeate pallets of packaged products at relatively low temperatures and kill bacteria and viruses that could cause life-threatening infections.
The EPA is updating the Clean Air Act’s National Emission Standards for Hazardous Air Pollutants (NESHAP) and working with the industry and state air agencies to reduce EtO emissions.
The agency has not threatened to ban EtO sterilization, but Whitaker asked the EPA to “carefully reconsider language that might unreasonably alarm residents near sterilization facilities” in response to the agency saying nearly two dozen plants presented elevated cancer risks to their communities.
Whitaker also called for the EPA “to embrace technology-neutral solutions to meet new emissions targets” and “to consider background EtO levels in ambient air and the tiny proportion of that represented by medical device sterilization EtO use.”
The medtech industry is working with the FDA to develop new and improved methods of medical device sterilization.
Sotera Health, parent company of major sterilization firm Sterigenics, recently agreed to pay $408 million to settle nearly 900 lawsuits alleging harm from EtO emissions. The company settled after an Illinois jury hit the company with a $363 million verdict in a case where a woman blamed the emissions for her family’s cancers.