The Trump EPA is moving to rescind Biden-era regulations that cracked down on the health industry’s use of ethylene oxide, a colorless gas used to sterilize 95 percent of all surgical kits and 50 percent of all medical devices used in the United States, the Washington Free Beacon has learned. [some emphasis, links added]
The agency will issue a proposal on Friday to restore more-attainable restrictions on ethylene oxide that had been in place for decades.
If finalized, it would scrap rules the Biden EPA issued in 2024 that forced the nation’s nearly 100 highly specialized medical sterilization facilities to slash ethylene oxide emissions by more than 90 percent—something that would have required them to either install expensive new pollution-control equipment within two years, or shut down.
Friday’s move is one of the Trump administration’s single largest deregulatory actions to date. It will save the medical device industry as much as $630 million over the next two decades, according to estimates from the EPA.
Hospitals and medical device manufacturers had argued the Biden-era rules were overly burdensome, would greatly reduce the number of devices that could be sterilized every year, and would push up health-care costs.
Medical groups warned at the time that the Biden rule would have dire consequences for patients.
“The reality will be very clear to many consumers who are already skipping necessary health care today due to the rising cost of living,” the Medical Device Manufacturers Association wrote after the Biden EPA first issued its regulations.
“EPA’s actions will mean fewer operations, fewer wellness and pediatric checkups, and longer wait times for life-changing procedures. EPA’s proposed actions will also exacerbate inequality in health care access.”
“We worry that the standards … could put at risk a vital component to protecting human health — delivering health care to those who need it, when they need it,” the American Hospital Association added.
The Trump EPA said rescinding those regulations will help avert a potential medical supply shortage, which it added would have undermined public health and national security.
At the same time, the agency will uphold previous regulations that establish emissions limits on ethylene oxide, which is a carcinogen.
“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,” said EPA Administrator Lee Zeldin.
According to the FDA, ethylene oxide is “the only acceptable sterilization method” for a large number of sophisticated medical devices like heart valves, pacemakers, surgical tools, gowns, drapes, ventilators, syringes, and catheters.
The chemical is used to sterilize roughly 20 billion such devices every year.
Top: President Trump tours a Thermo Fisher Scientific facility. The Trump EPA is rolling back Biden-era restrictions on a sterilization gas used on many medical devices. Official White House Photo by Joyce N. Boghosian.
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