The Environmental Protection Agency March 14 issued a final rule that will require significantly reduced emissions from commercial facilities that sterilize medical devices and other equipment using ethylene oxide gas. Among other changes, the rule will require continuous monitoring and reporting of EtO emissions and strengthen requirements for certain types of emissions that are not currently regulated, such as room air emissions. In a departure from the proposed rule, the EPA will give commercial sterilizers additional time to come into compliance with the requirements, and will apply emission percentage reduction targets that vary by a facility’s level of EtO emissions. The final rule will be published in the Federal Register soon. More information, including a fact sheet and video presentation, is available on the EPA’s website.

In a separate fact sheet, the White House expressed its desire to ensure that the final rule “protects communities located near sterilizing facilities while also mitigating and managing the potential risk of medical device shortages.” Noting that the Clean Air Act authorizes the president to grant commercial sterilizers up to two additional years to comply with the new standards, the White House said “it would be appropriate to exercise this authority if a sterilizer of medical devices was working in good faith to come into compliance with the rule, but the technology to implement these standards was not available for installation in the facility.” It said the federal government will provide additional details on the compliance exemption process in the coming months. 

Ashley Thompson, AHA’s senior vice president for public policy analysis and development, said, “Providing high quality patient care is the top priority for America’s hospitals and health systems. Hospitals rely on a supply of effectively sterilized medical devices to mitigate the risks of infection and keep patients safe. At the same time, they also work every day to protect and advance the health of the communities they serve. The processes used to sterilize medical devices must fully consider and substantially eliminate any detrimental effects on public health.

“As advocated by the AHA, the EPA’s final rule on ethylene oxide (EtO) emissions includes policies recognizing the fragility of the medical device supply chain as the Administration works toward the critically important goal of reducing these emissions. This includes giving sterilization facilities additional time to comply with lower emission levels, and providing the opportunity to apply for temporary extensions when facilities are working in good faith to come into compliance but are constrained by the availability of technologies to meet the new standards. The AHA thanks the White House, EPA, FDA and other agencies for their collaboration and coordination in developing this final rule.

“The transition to lower EtO emissions will be a complex process. We remain committed to working with the Administration, device sterilizers and other affected stakeholders to ensure it proceeds in a thoughtful, coordinated fashion that both improves public health and maintains a sufficient supply of sterilized medical devices to deliver patient care safely.” 

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