Sterilization Supply Risk in 2025: Navigating EtO Restrictions and Ensuring Continuity

Sterilization is a critical step in the medical device lifecycle. Without it, millions of life-saving devices such as catheters, surgical kits, implants, and diagnostic tools would never reach patients safely. Ethylene oxide (EtO) sterilization has long been the industry workhorse, used to sterilize more than 20 billion devices annually. Its effectiveness at penetrating complex geometries and sensitive materials makes it irreplaceable for many devices.

However, EtO is also a carcinogen, and growing environmental and public health concerns have led regulators in the United States and globally to tighten restrictions on its use. In 2023 and 2024, the U.S. Environmental Protection Agency (EPA) issued stricter emission standards, forcing many sterilization facilities to retrofit or risk closure. As of August 2025, companies face mounting pressure to secure compliant sterilization capacity, validate alternatives, and prepare regulatory submissions when processes change.

This blog examines the regulatory landscape for EtO sterilization, the challenges manufacturers face, and the strategies executives must adopt to protect supply chains and patient access.

Regulatory Landscape

United States

The EPA’s April 2024 final rule imposed strict new limits on EtO emissions from commercial sterilizers. Facilities must implement enhanced emission controls, including advanced capture systems, and in some cases redesign sterilization chambers. Compliance deadlines extend into 2028, but many facilities are already investing in upgrades or considering closure due to cost.

The FDA has acknowledged the risks of supply disruption and has been working with industry to explore alternatives, including vaporized hydrogen peroxide (VHP), gamma irradiation, and emerging technologies such as X-ray sterilization. However, FDA emphasizes that manufacturers must validate any change to sterilization methods through rigorous testing and often submit new 510(k)s, PMAs, or technical documentation updates.

Europe

The European Chemicals Agency (ECHA) is reviewing EtO under its REACH regulation. While not yet banned, EtO faces increasing restrictions, and Member States are pressuring sterilizers to adopt safer methods. Notified Bodies now scrutinize sterilization validation files more closely under MDR.

Global Trends

Other countries are watching closely. Canada and Japan are aligning with international standards on sterilization emissions. Emerging markets often rely on U.S. and EU precedent, so EtO restrictions are expected to ripple worldwide.

Why EtO Remains Essential

Despite the regulatory pressure, EtO remains the only viable method for many devices. It is uniquely suited to sterilizing products:

• With complex geometries such as long tubing.

  
  

• Made from heat- or radiation-sensitive materials such as plastics or electronics.

  
  

• Packaged in final barrier packaging that cannot tolerate other sterilization methods.

  
  

Alternative technologies cannot yet match EtO’s versatility at scale. Gamma irradiation is effective but has material compatibility issues and limited global capacity. VHP is useful for smaller loads but not ideal for high-volume industrial sterilization. X-ray sterilization is promising but still emerging and expensive.

This dependency on EtO means that manufacturers cannot simply switch methods overnight.

Practical Challenges for Manufacturers

1. Capacity Constraints: As sterilizers retrofit facilities to meet EPA standards, capacity has temporarily decreased. Manufacturers face longer lead times and competition for slots.

   
   

2. Validation Burden: Any change in sterilization process, even a facility retrofit, may require revalidation of product sterility assurance. This involves significant time and cost.

   
   

3. Regulatory Submissions: For FDA-regulated products, changes in sterilization may trigger a new submission. In Europe, updated technical documentation and Notified Body review are required.

   
   

4. Geographic Risks: Manufacturers dependent on a single sterilization facility face supply chain vulnerabilities if that facility reduces output or shuts down.

   
   

5. Public Perception: Communities near sterilization plants are increasingly vocal, pressuring operators and policymakers. Manufacturers may face reputational risk if they appear reliant on unsafe practices.

   
   

Strategic Responses

Diversify Sterilization Vendors

Relying on a single sterilizer is risky. Companies should qualify multiple vendors in different regions to spread risk. This may require parallel validations and documentation but pays off in resilience.

Evaluate Alternative Methods

While EtO remains essential, manufacturers should explore alternatives where feasible.

For example:

• Gamma or X-ray: Suitable for certain implants and surgical instruments.

  
  

• VHP: Useful for sensitive instruments in small to medium volumes.

  
  

• Moist Heat or Steam: Still viable for simple, heat-tolerant devices.

  
  

Even partial migration can reduce reliance on EtO.

Build Inventory Buffers

For critical products, maintaining strategic inventory can help bridge disruptions during facility upgrades or closures.

Collaborate with Sterilization Vendors

Work closely with sterilizers to understand their compliance timelines and upgrade plans. Establish long-term agreements to secure capacity.

Regulatory Planning

Involve regulatory teams early when sterilization changes are anticipated. Determine whether new submissions are required and prepare supporting validation data. Engage FDA through Q-Submissions or consult with Notified Bodies in advance.

Case Examples

• Company A: A cardiovascular device manufacturer faced delays when its primary sterilization vendor closed for retrofit. Without a validated alternative, shipments to hospitals were interrupted. The company scrambled to validate a second vendor, but regulatory submissions delayed recovery. The incident cost millions in lost sales and damaged relationships with clinicians.

  
  

• Company B: An orthopedic firm anticipated EtO restrictions early. It validated both EtO and gamma for its product portfolio and established dual sterilization vendors. When EPA rules took effect, it seamlessly shifted part of production to gamma, maintaining supply without disruption. Regulators commended its proactive risk management.

  
  

Strategic Implications for Executives

For CEOs and Boards

Sterilization is not just an operational issue, it is an enterprise risk. CEOs should ensure it is part of strategic planning, risk registers, and board-level discussions. The cost of inaction could be lost market share and reputational harm.

For Quality and Regulatory Leaders

QA/RA leaders must manage the dual challenge of maintaining compliance with existing sterilization methods while preparing for potential transitions. This means coordinating validations, ensuring technical documentation is current, and engaging with regulators proactively.

For Operations Leaders

Operations executives should evaluate geographic diversification of sterilization vendors and build redundancy into supply chains. Partnering with vendors to secure future capacity is essential.

Conclusion

Sterilization supply risk is one of the most pressing challenges for medical device companies in 2025. EtO restrictions, while driven by valid public health concerns, create potential bottlenecks for manufacturers who depend on it. Companies that plan proactively, validate alternatives, and collaborate closely with regulators and vendors will be best positioned to weather the disruption.

How PRP Compliance Can Help: We assist clients in validating sterilization alternatives, preparing regulatory submissions for process changes, and building risk management strategies to ensure continuous supply. Contact PRP Compliance to safeguard your products and patients against sterilization disruptions.