Trump Extends Ethylene Oxide Compliance for Medical Sterilization

The U.S. government has reversed a previous policy aimed at reducing the use of ethylene oxide (EtO) in medical device sterilization. President Donald Trump issued an executive order granting a two-year extension for compliance with new emission limits for facilities that utilize this chemical. This decision affects 39 medical device sterilization facilities nationwide and reflects a view that the required emissions-control technology is not commercially viable.

Ethylene oxide is a potent chemical known for its mutagenic properties, which can induce mutations in DNA and potentially lead to cancer. While various sterilization methods exist, such as gamma radiation, many medical devices require EtO for effective sterilization without damaging them. Concerns regarding EtO have been growing, especially in Europe, where its use has declined due to stringent regulatory requirements.

Despite these concerns, the executive order emphasizes the importance of maintaining a stable supply chain for medical devices. Over the past year, industry groups have actively lobbied the government, citing potential disruptions and implementation challenges. They argue that the extension is necessary to prevent adverse effects on availability and cost of medical devices.

Compliance Delays and Regulatory Context

The executive order cites the Clean Air Act, specifically section 112(i)(4), which allows the President to grant compliance exemptions under certain conditions. It states that “the technology to implement the EtO Rule is not available” in a commercially viable form. Additionally, the order posits that the exemption serves “in the national security interests of the United States.”

In March 2024, the U.S. Environmental Protection Agency (EPA) had issued a final rule aimed at updating the National Emission Standards for Hazardous Air Pollutants for commercial sterilization facilities. This rule sought to reduce EtO emissions by more than 90% through the installation of air pollution controls, impacting nearly 90 commercial sterilizer facilities operated by approximately 50 companies across the country.

The EPA’s regulations include stringent requirements for building leaks, chamber exhaust vents, and continuous emissions monitoring. Approximately 50% of all sterile medical devices in the U.S. are sterilized using ethylene oxide, with no alternative methods feasible for many devices without compromising their integrity.

Health Risks and Industry Response

The health implications of ethylene oxide exposure are significant. Inhalation can lead to symptoms such as eye and nose irritation, coughing, and in severe cases, lung damage. Long-term exposure may result in more severe health risks, including headaches, stomach issues, and heart problems.

International standards, such as ISO 10993-7 and ISO 11135, govern the use of EtO in medical devices, setting limits for residual levels to mitigate health risks. The EPA’s decision to extend compliance deadlines deviates from these standards, raising eyebrows among health advocates and regulatory bodies.

The implications of this executive order may reverberate throughout the medical device industry. As facilities remain subject to emissions and compliance obligations that were in effect prior to the EPA’s EtO rule, the potential for increased environmental and health risks persists.

By extending the compliance timeline, the Trump administration aims to balance industry demands with public health concerns, though it remains to be seen how this will impact the future of ethylene oxide use in medical sterilization.