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US eases limits on cancer-causing gases used to clean medical equipment

The Trump administration proposes to lift certain restrictions on the?use of ethylene dioxide, a carcinogenic?gas?used for sterilisation. They claim that previous restrictions imposed by former president?Joe Biden could hinder medical 'device manufacturers' ability to clean their facilities.

The U.S. Environmental Protection Agency released a statement Friday saying that its proposed rule would not only follow the current law, but also make it easier for businesses to adhere to commercial sterilization regulations. It will also save costs and protect the nation's supplies chain for devices such as heart stents.

Medical officials, industry representatives and the Food and Drug Administration have all expressed concern about the stricter rule that was issued in 2024 by the Democratic Biden administration. This included a required second risk review as well as new standards requiring new'monitoring systems', vents, and enclosures.

The new proposal allows medical device companies to choose between installing new monitoring systems or making adjustments to the new aeration rooms vents where ethylene dioxide is more than 10 tons per annum.

The EPA stated that "These changes better represent the complexity of facilities, and give them flexibility to work with safe and effective equipment for sterilizing?medical devices and tools without compromising the clean air for Americans," in a press release.

It added that they would also save a?estimated $43 millions annually.

EtO is a colorless, toxic?gas that's used to sterilize equipment. The long-term effects of exposure to EtO have been linked to cancer.

According to the EPA, about half of medical devices manufactured in the United States each year are sterilized using this gas.

The proposed rule will be subject to a public hearing in 15 days. Public comments are then accepted for 45 days, before the final decision is made by the administration. (Reporting and editing by David Gaffen; Valerie Volcovici, Susan Heavey)

(source: Reuters)