EPA moves closer to stricter regulations of medtech ethylene oxide sterilization

The Environmental Protection Agency yesterday asked the commercial ethylene oxide (EtO) industry, which includes medical device sterilizers, for input on next year’s updated regulation of emissions of the carcinogenic gas.

Specifically, the EPA is requesting comment on available control technologies for reducing EtO emissions and on developments in practices, measurement, monitoring, processes and control technologies for the sterilant.

The EPA described several emissions-control methods for the industry to consider, and said it would take into consideration the costs of compliance to small businesses. Of the 108 EtO facilities that would be affected by the new regulation, the agency identified 35 as being owned by small businesses. There are 59 total parent companies, 27 of which are small parent companies.

Yesterday’s request for comment comes one month after the agency issued a proposal to reduce industrial EtO emissions by 93%.

The crisis over medtech sterilization using EtO began in February 2019, when a Sterigenics EtO plant in Willowbrook, Ill. was shut down by state officials. Since then, two other facilities were shut down in Georgia, although one has reopened. Viant signed a consent agreement this week with the state of Michigan to stop using EtO at its plant in Grand Rapids.

The stakes are high for the medtech 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 EPA said recognizes the important role of ethylene oxide in sterilizing medical devices and is working closely with the FDA and other federal partners.

“Today’s action is another step in the Trump administration’s efforts to address ethylene oxide emissions across the country and soliciting feedback from citizens and stakeholders is an important step in the process,” said EPA administrator Andrew Wheeler in a news release. “Medical device sterilization is vital to protecting public health. As EPA takes steps to reduce ethylene oxide emissions from facilities we are committed to working with our federal partners as they are working to advance medical device sterilization.”

Medtech industry trade group AdvaMed told Medical Design & Outsourcing in an email that it is reviewing the details of EPA’s request and intends to submit comments by the prescribed deadline — 60 days from publication in the Federal Register.

“We are pleased EPA has shown so much interest in the medical technology industry’s views, and how we responsibly control and destroy these emissions,” an Advamed spokesman said. “The administrator’s own comments mentioning our manufacturers in his statement is testament to their concern for getting this policy right and being mindful of all industries in this process.”

Among its options, the EPA said it might reinstate requirements for sterilization chamber exhaust vents, which removes EtO-laden air from the sterilization chamber after the chamber door is opened following the sterilization cycle. The agency eliminated regulations governing these vents following a series of explosions at EtO plants in the late 1990s, saying it could not conclude whether those vents could be safely controlled.

The agency has also never set standards for fugitive EtO emissions, which result from off-gassing and are not routed to a pollution control device. The magnitude of the fugitive emissions from the industry is not well characterized, the agency said.

Other options include process equipment improvements and advances in add-on control technologies for EtO sources. The EPA also wants EtO usage data for individual facilities.

The EPA’s National Air Toxics Assessment (NATA) released in August 2018 estimates that EtO significantly contributes to potential elevated cancer risks in some census tracts across the U.S. (less than 1% percent of the total number of tracts). These elevated risks are largely driven by an EPA risk value that was updated in December 2016. The EPA conducted a previous assessment of the health effects of EtO exposure in 1985.

The FDA is also working with the medtech industry to reduce EtO usage. the FDA is recommending that medtech companies reduce the amount of paper (such as the labeling and instructions for use manuals) included in a sterile device package and move to delivering that information electronically. A large amount of paper in an EtO sterilization chamber hinders the gas getting to the device and results in higher EtO usage, the agency explained. The FDA said it is working with medtech manufacturers to make the switch where feasible and safe for patients.

To prevent and alleviate device shortages brought on by the EtO crisis, the agency also said it would expedite approvals of certain changes that medtech manufacturers make to EtO sterilization methods, processes and facilities. Currently, the FDA requires manufacturers that want to change sterilization methods, processes or facilities to submit a premarket authorization (PMA) supplement before they can make those changes. “However, considering the recent sterilization facility closures and concerns about their impact on medical device availability, we recognize the need to facilitate timely process and site changes that may reduce the amount of ethylene oxide used and minimize the impact of supply interruptions,” the agency said in a statement last month.

Once the EPA request for information is published in the Federal Register, individuals and companies will have 60 days to submit comments.

Via https://www.medicaldesignandoutsourcing.com/epa-moves-closer-to-stricter-regulations-on-medtech-ethylene-oxide-sterilization/