Trump’s EPA wants to roll back Biden-era pollution limits for medical device sterilization
The U.S. Environmental Protection Agency (EPA) is looking to relax certain ethylene oxide (EtO) standards first put in place by the Biden administration. The agency’s proposal, if finalized, would undo a primary component of Biden’s “cancer moonshot” initiative.
EtO is used to sterilize pacemakers, leads, stents, catheters and many other medical devices used to treat heart patients on a daily basis. The colorless gas is known to be effective, and few alternatives are available, but long-term exposure can cause cancer.
Biden’s EPA worked to reduce EtO emissions in multiple ways—so much, in fact, that many healthcare groups feared these changes could have a negative impact on patient care. In 2023, for example, the American College of Cardiology, Heart Rhythm Society, Society for Cardiovascular Angiography & Interventions, Society for Thoracic Surgeons and Society of Interventional Radiology all signed a letter asking for more time and flexibility so that sterilization facilities could adjust to these major policy changes.
“We support efforts to reduce community risk through the minimization of emissions and exposure to EtO,” the groups wrote. “At the same time, it is crucial that the supply chain of critical medical devices and patient care are not put at risk.”
President Trump first made this issue a priority in 2025 with a proclamation that temporarily paused the implementation of the Biden-era emissions policies. This new proposed rule, if signed into law, would make a more permanent impact.
“This proposed rule shows EPA’s strong commitment to protecting people’s health while maintaining a stable domestic medical supply chain,” EPA Administrator Lee Zeldin said in a statement. “The Trump EPA is committed to ensuring life-saving medical devices remain available for the critical care of America’s children, elderly and all patients without unnecessary exposure to communities.”
According to the EPA, the U.S. Food and Drug Administration and a long list of industry stakeholders have “raised serious concerns” that the Biden-era policies could upset the supply chain and put patients at risk. If this new proposal is finalized, however, it would cancel out many of those policies and give sterilization facilities more flexibility when working to monitor its emissions in the future.
The EPA is now accepting public comments on this proposal. Click here for more information from the agency.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.