Two proposed regulations to limit the use of ethylene oxide (EtO) and the facilities that use the sterilizing agent could have a “devastating” impact on the medtech industry and patient access to life-saving products, according to two industry groups.
In April, the EPA published the two much-anticipated proposed regulations. If finalized, the rules would put additional limits on how much EtO can be released into the environment, how much of the agent can be used to sterilize products and how workers who handle the gas are allowed to operate in its proximity. (RELATED: EPA proposes rules on EtO with implications for medical device sterilization, Regulatory Focus 11 April 2023)
The agency previously released a report stating EtO sterilization facilities pose an increased cancer risk to neighboring communities; the aim of the proposed regulations is to reduce the risk of cancer for workers and people living adjacent to sterilization plants. (RELATED: EPA lists potentially high-risk EtO plants, plans to finally publish air pollution rule by year’s end, Regulatory Focus 3 August 2023)
Medtech lobby groups AdvaMed and the Medical Device Manufacturers Association (MDMA) disagree with EPA’s assessment, and in comments made to the agency argued that EtO emissions from sterilization plants are hard to distinguish from background levels of EtO. They also warned that EPA’s proposed regulations could put a significant portion of the medical device sterilization industry out of business and others would have to pause their operations while coming into compliance with the rules – potentially leading to shortages of medical devices…
