On July 17, 2025, President Donald Trump issued an executive order granting 39 medical device sterilization facilities a two-year extension to comply with new ethylene oxide (EtO) emissions limits. This move follows months of industry pushback and growing concerns about potential disruptions to the medical device supply chain.

As consultants who work closely with combination product and medical device manufacturers, we see this development as both a temporary relief and a strategic inflection point. For companies relying on EtO sterilization, the message is clear: use the extra time wisely.

Why EtO Matters

Ethylene oxide is a low-temperature sterilant used to treat approximately 20 billion medical devices annually in the U.S. It’s indispensable for products that cannot withstand steam or radiation. However, EtO is also classified as a human carcinogen. In 2022, the EPA proposed strict emissions limits in response to growing public health concerns, particularly for communities near sterilization plants.

The new rules, finalized in 2024, were expected to drive sweeping changes to facility operations, emissions monitoring, and air filtration systems. Facilities were given 18 months to comply: until late 2025.

But many manufacturers and contract sterilizers warned that meeting the requirements within that timeframe was technologically and logistically unfeasible. The risk: an overwhelmed system and widespread device shortages.

What the Executive Order Does

Trump’s executive order, titled “Regulatory Relief for Certain Stationary Sources to Promote American Security with Respect to Sterile Medical Equipment,” specifically delays enforcement for 39 facilities named in the EPA’s final rule. These facilities now have until late 2027 to fully comply.

The administration justified the delay by citing a:

1. Lack of alternative sterilization capacity

2. Infeasibility of rapid technology adoption

3. National security implications of disrupted medical supply chains

The order does not eliminate any of the emissions limits. It only allows additional time to reach them.

Implications for the Life Sciences Industry

For manufacturers, especially those with products labeled sterile by EtO, this is a critical window. While the extension reduces short-term pressure, the long-term requirements are unchanged. Facilities must still:

• Upgrade or replace legacy abatement systems

• Validate new sterilization cycle parameters

• Meet stricter ambient monitoring and reporting thresholds

In our work with device and combination product companies, we’ve observed three key response patterns:

1. Strategic Diversification
   Some organizations are actively qualifying alternative sterilization methods – like gamma, steam, or vaporized hydrogen peroxide – for a portion of their portfolio.

2. Accelerated Validation Planning
   Others are using the extension to develop detailed EtO validation and requalification plans, including worst-case scenarios and revised packaging studies.

3. Stakeholder Coordination
   Manufacturers are also increasing communication with their contract sterilizers, as well as with QA/RA and supply chain teams, to align on risk mitigation strategies.

FDA Position & Future Considerations

The FDA has acknowledged the sterilization crisis and expressed support for innovative solutions, including new technologies and pilot programs. In 2024, the agency expanded its Innovation Challenge for EtO Alternatives and signaled openness to streamlined reviews for certain sterilization changes.

But the regulatory burden is still real. Any change to sterilization method, site, or parameters must be appropriately filed, often through a PMA supplement, 510(k) update, or Device Master File amendment.

Additionally, environmental regulations are not going away. State-level enforcement, especially in places like California and Illinois, may proceed faster than federal mandates. Companies that delay compliance planning risk nonconformance at the state level.

What Should Companies Do Now?

The best way to view this delay is as a temporary reprieve, not a permanent rollback.

The QSN team recommends the following actions:

• Audit your sterilization dependencies. Identify SKUs and product lines reliant on EtO and determine their regulatory status, filing type, and supply chain location.

• Engage with your contract sterilizers. Ask about their technology upgrade timelines, validation schedules, and EPA reporting plans.

• Evaluate change control and QMS readiness. Ensure that sterilization-related changes are integrated into your quality system and risk management file updates.

• Plan for requalification now. Waiting until 2027 is a recipe for bottlenecks. Early preparation will reduce delays, costs, and compliance risks.

Read the official executive order here. 

Need support with your sterilization strategy or regulatory risk planning?

Contact us to learn how QSN can help ensure your supply chain stays resilient and compliant.