WASHINGTON, March 13 (Reuters) – The Trump administration is proposing to lift some limits on the use of ethylene oxide, a carcinogenic gas used for sterilization, saying previous constraints imposed under former President Joe Biden may hamper medical device makers’ ability to clean their facilities.
In a statement on Friday, the U.S. Environmental Protection Agency said its proposed rule would follow current law but make it easier for companies to follow commercial sterilization regulations while also saving costs and protecting the nation’s supply chain for devices such as heart stents and wound dressings.
The medical community, industry officials and the Food and Drug Administration all expressed concerns about the more stringent rule issued in 2024 under the Democratic Biden administration, which included a second required risk review, as well as standards that required new monitoring systems, vents and enclosures.
The new proposal would allow medical device companies a choice between installing new monitoring systems or making other adjustments to new aeration room vents in areas where ethylene oxide is greater than 10 tons per year.
“These changes better reflect the complexity of facilities and give them the flexibility to work to use safe and effective equipment to sterilize medical tools and devices without compromising clean air for all Americans,” the EPA said in a statement.
They would also save an estimated $43 million annually, it added.
Ethylene oxide, or EtO, is a colorless gas used to sterilize equipment, but its toxic emissions pollute the air. Long-term exposure has been linked to cancer, especially for people living close to manufacturing plants that make or use it.
The gas is used to sterilize about half of all U.S. medical devices made each year, according to the EPA.
The proposed rule will face a public hearing in about 15 days and is open to public comment for 45 days before the administration makes a final decision.
(Reporting by Susan Heavey and Valerie Volcovici; editing by David Gaffen)
