Trump Extends Ethylene Oxide Compliance for Medical Device Sterilization

President Donald Trump has issued an executive order extending compliance deadlines for medical device sterilization facilities regarding the use of ethylene oxide (EtO). This decision allows an additional two years for 39 specific facilities to meet the environmental standards set by the U.S. Environmental Protection Agency (EPA). The reversal of the previous policy, which aimed to reduce the use of EtO in medical device sterilization, has raised concerns among health advocates and industry experts.

Ethylene oxide is a widely used sterilant for medical devices, necessary for ensuring they remain free of harmful microorganisms. Despite its effectiveness, EtO has been associated with significant health risks, including its mutagenic properties that can lead to DNA alterations and potentially cancer. As a result, regulatory bodies in Europe have progressively reduced its use, largely influenced by stringent safety regulations.

The executive order, signed by President Trump, asserts that the required emissions-control technology is not commercially viable for the facilities involved. The order cites two key determinations: the lack of available technology to comply with the new EPA rule and the assertion that the exemption is necessary for the national security interests of the United States.

In March 2024, the EPA had issued a final rule aimed at reducing EtO emissions by more than 90%. This regulation affected nearly 90 commercial sterilizing facilities across the nation, requiring improved air pollution controls and continuous emissions monitoring. According to the FDA Group, the compliance extension means that the facilities will operate under the previous emissions standards until the new regulations take effect.

Trade groups representing the medical device industry have been lobbying for this extension, expressing concerns about potential supply chain disruptions and the challenges associated with meeting the new regulations. They argue that sterilization with EtO may be the only viable method for many medical devices, particularly those sensitive to other sterilization methods like gamma radiation.

The executive order references the Clean Air Act, which permits the President to grant compliance exemptions under specific circumstances. Trump’s decision to extend the compliance timeline has sparked debate, especially as other countries move to limit the use of EtO in favor of safer alternatives.

As the medical device industry navigates these regulatory changes, the implications for public health and safety remain uncertain. Stakeholders will be closely monitoring the developments surrounding the compliance extension and its potential effects on the sterilization practices of medical devices in the United States.