How can medtech overcome its ethylene oxide sterilization crisis?

Until recently, the debate over the widely used sterilant gas ethylene oxide (EtO) has been largely waged on state and local levels in the U.S. But now it’s going public at the federal level.

From city council chambers to judges’ chambers, through volleys of press releases and the clamor of citizen picket lines, the stream of information has been relentless since February 2019, when a Sterigenics EtO plant in Willowbrook, Ill. was shut down by state officials.

The stakes are high for the industry, the healthcare systems and the public. More than 20 billion medical devices are sterilized using EtO annually, according to the trade group AdvaMed. The Sterigenics Willowbrook plant closure sent hospitals scrambling for alternative sources of critical devices. Although no major device shortages have ensued, the FDA and the industry have issued dire warnings about that possibility.

The FDA had been talking privately with officials at other federal agencies as well as with the medtech and healthcare industries. On Wednesday and Thursday, it will open up the floor to experts from the EPA, the Centers for Disease Control, healthcare systems, medtech manufacturers, sterilization companies and members of the public to discuss how to reduce EtO emissions and find alternatives to EtO.

The 27-member Center for Devices and Radiological Health General Hospital and Personal Use Devices Panel will accept electronic comments at https://www.regulations.gov through Dec. 6, after which it will make its recommendations.

The panel will consider questions that fall under three broad categories: Impact on the medtech ecosystem, reducing EtO use and emissions, and potential alternatives to EtO. Here is a summary of the questions:

Impact on the greater medtech ecosystem

1. If EtO sterilization is reduced, eliminated or replaced by a different sterilization method, how can the impact on healthcare delivery organizations be minimized?

2. What can the FDA do to help mitigate and prevent device shortages due to reduced device sterilization capabilities?

Reducing EtO use and emissions

3. How can changing EtO sterilization cycles or sterilization loads reduce EtO use while maintaining effective sterilization? Can the panel recommend which methods seem most promising?

4. Can new or different methods of validating EtO sterilization cycles potentially result in a reduction of EtO use while still maintaining an effective sterilization process? If so, how?

5. Should some medical devices be sterilized to a less rigorous sterility assurance level? How might this change the patient risk profile if an acceptable level is found?

Potential alternatives to EtO

6. Can any existing large-scale industrial sterilization modalities take over a portion of the EtO sterilization performed for medical devices in the short or long term? If so can the panel provide a discussion of the path forward for these modalities? If not, what are the barriers and challenges preventing wider use of these modalities?

7. Are there alternative sterilization methods being developed that can take the place of EtO sterilization processes with respect to scalability and material compatibility? If so, can the panel discuss the path forward for these modalities? If not, what are the barriers and challenges preventing large-scale industrial utilization of these modalities?

8. How can FDA help implement the adoption of these EtO-reduction or -replacement strategies and enable the reduction of EtO emissions within our regulatory framework?

9. Can the panel identify devices or device types that would be difficult to sterilize without using EtO that may be amenable to the application of alternative sterilization modalities?

10. Does the panel have any other recommendations for reducing EtO risk without causing medical device shortages?