EtO Regulations a Major Talking Point at MedCon 2023

Ethylene oxide (EtO) was a hot topic at the recent MedCon 2023 conference in Columbus, OH, with more than one session mentioning the EPAs proposed rules further regulating the sterilizer for medical technology and other commercial uses through the National Emissions Standards for Hazardous Air Pollutants (NESHAP) under the Clean Air Act.

In the session “Office of Regulatory Affairs (ORA) Office of Medical Device and Radiological Health Update,” speakers highlighted FDA’s role to “assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices,” of which many are sterilized using EtO. In turn, they discussed the cross governmental coordination taking place on sterilization issues and regulations with EPA, ASPR, and the White House.

FDA communications regarding EtO included the April 11 announcement of its Radiation Sterilization Master File Pilot Program. The program, which was previously reported on by MD+DI, is only for PMA-approved devices and voluntary.

“[It] will allow nine eligible sterilization providers that target single-use medical devices using gamma radiation or EtO to submit a master file to change methods — including the reduction of gamma radiation dose or use of non-gamma radiation sources like x-ray or electron beam,” MD+DI reported. “The master file, which will hold a wealth of information about a sterilization providers participation in the pilot program, would then be considered for use as an alternative to regular procedure when changing sterilization methods.”

Other communications mentioned in the session included the CDRH Center Director’s statement on the issue and updated FDA webpages.

Apart from the launch of the Radiation Master File Pilot Program, FDA also currently maintains two EtO innovation challenges. The first innovation challenge is to identify new sterilization methods and technologies. After receiving 24 applications, FDA selected four company’s and five submissions for the challenge.

“The goal of this challenge is to identify safe and effective sterilization methods or technologies for medical devices that do not rely on ethylene oxide,” according to FDA's innovation challenge webpage.

The second innovation challenge focuses on developing strategies to reduce EtO emissions.

“The goal of this challenge is to develop strategies or technologies to reduce emissions to as close to zero as possible from the ethylene oxide sterilization process,” FDA wrote on the second challenge webpage. “Innovative strategies may entail changing current sterilization processes or workflow, such as changes in the supply chain, transportation of medical devices, or procedures in the sterilization site. Strategies may also include making alterations to ethylene oxide process waste to reduce emissions.”

Of the 22 applications, FDA selected eight participants:

Additional actions highlighted in the session were the PMA Master File Pilot Program and the launch of the 510(k) EtO Master File Pilot Program. The 510(k) program was put in place to help companies move away from EtO faster compared to tradition pathways if other ways to sterilize devices as effectively are possible. Much like the Radiation Sterilization Master File Pilot Program, the 510(k) program allows participants to reference the master file to make the switch in sterilization methods.

FDA also continues to partake in shortage assessments and stakeholder engagement.

In the session, “Sustainability Through the Supply Chain” — specifically referring to the industry perspective section of the discussion — speakers discussed sustainability challenges when sterilizing medical devices with EtO. They highlighted how evolving regulations have impacted availability of EtO sterilization suppliers. As a result, the output of existing sterilizers has been affected.

The multi-year process to validate and approve alternative modalities for sterilization is also problematic, they said, as many products will not tolerate other sterilization methods. Of the products that would be able to tolerate alternatives, these modalities would have to be evaluated during the design process to make sure all components come out both sterilized and unharmed.

The session also mentioned the ongoing partnerships with FDA through multiple forums, including the master file programs, Resilient Supply Chain Program, CDRH, and innovation challenges. On the industry side, groups have also formed in recognition of the “importance [of] establishing and harmonizing sterilization standards and development of sustainable sterilization methods,” according to the session.

That is to say, it seems both industry and regulatory bodies are making sure to keep the medtech community as informed as possible as new rules are proposed, and innovation continues in sterilization.