Medical Device Sterilization’s Next Generation

Several years ago, the EPA began looking into concerns involving medical device sterilization facilities. The output of ethylene oxide (EtO)—a known human carcinogen—from these locations was the suspected cause of increased health risk for the surrounding community. The EPA’s response was to close some facilities because they determined the levels detected were above what they considered safe. Proponents for the sterilization method pointed to new measurement methods by the agency as the reason for the unacceptable levels. Either way, it was clear EtO was in the spotlight and its future was uncertain.

Uncertainty is not something medical device manufacturers enjoy. Given 50% of all medical devices use EtO for terminal sterilization, it’s no wonder this news caused some to lose sleep. Would the EPA ban use of EtO outright or require levels too low to effectively sterilize medical devices? Such a decision would leave manufacturers scrambling for an alternative; something the industry is still not equipped to provide.

Enter the COVID-19 pandemic and all this was quickly shuffled to the back-burner. In fact, the EPA temporarily allowed some facilities to reopen as a result of the pressing need for product sterilization to combat the virus. This was a short-term response, though—with the pandemic in the rear-view mirror, the industry anxiously awaits the EPA’s decision.

Fortunately, procrastination did not take hold and many responded to the potential need to find alternative methods for terminal sterilization. Darci Diage, founder and CEO of TPL Consulting, provided an overview of the most common sterilization options at the 2023 MPO Summit (available on demand now through the website). While there are manufacturers who may not have properly performed due diligence for a new product regarding the sterilization method they employed and simply selected EtO because it’s most commonly used, Diage explained that’s changed now. She stated almost every developer of new medical devices is exploring multiple sterilization method options.

The U.S. Food and Drug Administration (FDA) also did not sit idly by to await the EPA’s decision on EtO’s ultimate fate. The regulatory agency became quite active in motivating the industry to explore alternatives for sterilization. In 2019, the agency put forward two challenges to help bolster the industry’s ability to sterilize medical devices at the volume required, should EtO be banned. The first—Identify New Sterilization Methods and Technologies—generated 24 submissions with four companies and five technologies being selected to continue in the competition.

• NovaSterilis: Supercritical Carbon Dioxide Sterilization
• Noxilizer Inc.: Nitrogen Dioxide Sterilization
• STERIS: Accelerator-Based Radiation Sterilization & Vaporized Hydrogen Peroxide (VHP) Sterilization
• TSO3 (now Stryker): VHP-Ozone Sterilization

The second challenge—Reduce Ethylene Oxide Emissions—resulted in 22 applications. Eight were selected to continue.

• Abbott, BD, Medtronic, Sterigenics, & STERIS:Enhanced EtO Cycle Design and Processes
• Andersen Scientific Inc.: Use of EtO-Flexible Chamber Technology
• DMB Apparatebau GmbH: Reduced Sterilant Concentration
• Taiwan Advanced Sterilization Technologies Inc.: Abatement Strategy

While the FDA hasn’t declared a “winner” of these challenges (not sure one will be named), the agency did recently make a statement tying back to the first group. Specifically, a week after the start of 2024, the agency endorsed broader use of VHP for medical device sterilization in a press release. Concurrently, FDA revised the final guidance—Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile—to list VHP as an example of an Established Category A method of sterilization.

“Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages,” Suzanne Schwartz, M.D., M.B.A., director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, said in the release.

The EPA’s decision is expected to be revealed later this year (perhaps spring) with enforcement taking place in the remainder of 2024 and 2025. What that ultimate decision will be is anyone’s guess, but industry should not wait. If you rely on EtO for sterilization for any of your products, you must have a plan in place should it be banned. Are you ready? 

Sean Fenske, Editor-in-Chief
[email protected]