Trump Extends Ethylene Oxide Compliance Deadline for Medical Devices

The U.S. government has reversed crucial policies aimed at reducing the use of ethylene oxide (EtO) in medical device sterilization. President Donald Trump signed an executive order granting a two-year extension for compliance with new emissions limits affecting 39 sterilization facilities across the country. This decision comes amid ongoing concerns regarding the chemical’s mutagenic properties and its potential health risks.

Ethylene oxide is commonly used to sterilize medical devices, with around 50% of all sterile medical devices in the U.S. relying on this method. The executive order has drawn attention due to the health implications associated with EtO, which can cause DNA mutations and has been linked to cancer. Inhalation of the chemical can lead to symptoms ranging from eye irritation and coughing to severe lung damage in extreme cases.

In March 2024, the U.S. Environmental Protection Agency (EPA) issued a final rule aimed at reducing EtO emissions by over 90%. This rule mandated the implementation of air pollution controls at commercial sterilization facilities, which are operated by approximately 50 companies nationwide. The new regulations required continuous emissions monitoring and set specific standards for building leaks and chamber exhaust vents.

Despite these regulations, the executive order cites a lack of commercially viable technology needed to comply with the EPA’s requirements. The order invokes section 112(i)(4) of the Clean Air Act, which allows the President to grant compliance exemptions under certain circumstances. The order states that the exemption is “in the national security interests of the United States” and that the technology to implement the EPA’s EtO Rule is not available.

Concerns about potential supply chain disruptions have prompted medical device trade groups to lobby the government for this extension. These groups argue that the challenges associated with implementing the new regulations could jeopardize the availability of essential medical devices. Their lobbying efforts highlight logistical and economic motivations behind the push for an extension.

The reversal of the EPA’s decision marks a significant shift in U.S. policy regarding the use of ethylene oxide. In Europe, the use of EtO has declined significantly, largely driven by stricter regulatory requirements. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has consistently expressed concerns about the risks posed by EtO residues in medical devices.

As the two-year extension takes effect, facilities will continue to operate under the previous emissions control obligations. The compliance deadline extension reflects the complex balance between public health concerns and the operational realities faced by medical device manufacturers.

This recent development raises questions about future regulatory approaches to hazardous materials in medical settings. As the U.S. navigates its health and safety regulations, the implications of this executive order will be closely monitored by health professionals and industry stakeholders alike.