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Home – Environmental Activism News – EPA, Don’t Regulate Away America’s Medical Device Sterilization Industry

EPA, Don’t Regulate Away America’s Medical Device Sterilization Industry

Sarah Wagoner | Jacob Twyford

RealClearWire—In 2024, the Environmental Protection Agency tried to make it harder for hospitals to obtain essential sterilized medical equipment by threatening to regulate the American industry out of business. Two years later, the EPA is finally safeguarding the medical equipment supply chain by rescinding a damaging and badly conceived rule.

The rule centers on a substance known as Ethylene Oxide. Although it causes cancer when inhaled at unsafe levels, EtO is a critical chemical used to sterilize half of all medical equipment such as bandages, pacemakers, and surgical kits that cannot withstand other sterilization methods. In a 2024 Final Rule, the EPA tried to force medical sterilization centers to build near-perfect infrastructure to reduce their EtO emissions to 0.1%. Under the previous standard, the

EPA allowed only 1% into the atmosphere. To meet the new, more stringent standard, the 2024 Final Rule mandated Permanent Total Enclosure requirements that the EPA is now acknowledging were too expensive and risked shutting down small sterilization facilities. Most PTE systems are custom-designed, and the EPA estimates the annualized costs to implement would be $9.4 million per year, spread across 28 facilities. For larger businesses, adding over $335,000 in annual compliance costs is manageable, but slapping on such a large expense on a small business risks driving them out of........

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