2026年3月13日 美国东部时间晚上7:04 / 路透社
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华盛顿，3月13日（路透社）- 特朗普政府正提议取消对环氧乙烷（一种用于消毒的致癌气体）使用的部分限制，称拜登政府时期实施的先前限制可能阻碍医疗设备制造商清洁其设施的能力。
美国环境保护署周五在一份声明中表示，其拟议的规则将遵循现行法律，但会让企业更容易遵守商业消毒规定，同时节省成本并保护美国心脏支架和伤口敷料等设备的供应链。
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医学界、行业官员和美国食品药品监督管理局均对拜登政府（民主党）2024年颁布的更为严格的规定表示担忧，该规定包括第二次强制风险审查，以及要求新的监测系统、通风口和围护结构的标准。
新提议将允许医疗设备公司在以下两种选择中任选其一：安装新的监测系统，或对环氧乙烷年使用量超过10吨的区域的新通风室通风口进行其他调整。
美国环境保护署在声明中表示：”这些变化更好地反映了设施的复杂性，并为他们提供了灵活性，使其能够在不损害所有美国人清洁空气的前提下，使用安全有效的设备对医疗工具和器械进行消毒。”
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该机构补充称，这些调整每年还将节省约4300万美元。
环氧乙烷（EtO）是一种无色气体，用于对设备进行消毒，但其有毒排放物会污染空气。长期接触环氧乙烷与癌症相关，尤其是对居住在生产或使用该气体的工厂附近的人群。
美国环境保护署表示，该气体被用于对美国每年生产的约一半医疗设备进行消毒。
拟议的规则将在约15天后举行公开听证会，并开放45天公众意见征询期，之后政府将做出最终决定。
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Susan Heavey和Valerie Volcovici报道；David Gaffen编辑
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US proposes easing limits on cancer-causing gas used to clean medical devices
March 13, 2026 7:04 PM UTC / Reuters
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A 3D-printed miniature model of U.S. President Donald Trump with the Environmental Protection Agency logo in the background is seen in this illustration taken April 23, 2025. REUTERS/Dado Ruvic/Illustration [Purchase Licensing Rights, opens new tab]
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.
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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.
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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.
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Reporting by Susan Heavey and Valerie Volcovici; editing by David Gaffen
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