EPA Pressures Device Firms on Sterilization Activities

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Some provisions in the EPA’s recent ethylene oxide emissions and worker safety plans could challenge operations at device sterilization plants, medtech industry advocates warn based on an initial review of the documents. Device groups are asking for an extended public comment period to ensure industry is able to fully engage on EPA’s proposals, which raise complex technical issues and threaten device shortages if the hurdles are placed too high.

The Environmental Protection Agency will be a major target of medtech industry engagement and a potential source of consternation over the next year. EPA dropped 300-plus pages of proposals April 11 to address public health impacts from the use of ethylene oxide (EtO) gas, which is used to sterilize about 20 billion devices per year. Medical device and sterilization firms are poring over the technical documents to understand the implications. But initial signals from people spearheading industry’s response point to concerns about the feasibility of implementing EPA’s plans as they currently stand. Industry groups are expected to push for several substantive changes before the proposals are finalized.

The EtO proposals didn’t appear out of thin air, of course. Going back to 2016, the EPA published an updated carcinogenic risk assessment of EtO and concluded that the risks were higher than had previously been understood. The agency followed that up with a series of other assessments focused on EtO health impacts on people living near commercial sterilization facilities and employees of these facilities, among others. In response to its data, EPA has raised alarms about EtO public health risks, including its decision last year to publicly post a list of dozens of device sterilization facilities around the country responsible for “elevated risks” to surrounding communities based on modeling information of EtO emissions.


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