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Medical Device Makers See Progress in EO Sterilization

Topic: Medical Device Makers See Progress in EO Sterilization

Public and governmental alarm about the use of ethylene oxide (EO) for sterilization of medical devices is driving device manufacturers, contract sterilizers, and other stakeholders to double down on developing sterilization processes that reduce or eliminate the use of EO.

“Ethylene Oxide Sterilization: An FDA & EPA Update,” presented during 2020 Virtual Engineering Week by Mac McKeen, fellow, regulatory science, at Boston Scientific, presents the regulatory lay of the land, as well as strategies for reducing reliance on EO. Watch the full 30-minute presentation in this video.

EO has been used as a sterilant since the 1930s and is currently used on about 50% of healthcare products in the United States — or more than 20 billion medical products per year. It’s the friendliest method of sterilization for medical devices, as EO does not degrade device materials.

But in recent years, citizens and governmental agencies have grown concerned about EO emissions from sterilization facilities and the potential health effects not only on plant workers but also on nearby residents.

At the US Environmental Protection Agency (EPA), which classified EO as a human carcinogen in 2016, mitigating the risk associated with EO continues to be a priority.

McKeen points to EPA’s recent focus on “fugitive emissions” from sterilization facilities, noting that the agency put monitoring and reporting protocols in place via a Federal Register notice in June 2020. The agency is expected to issue a final rule limiting EO emissions from sterilization facilities in 2021.

The Food and Drug Administration (FDA) is also working with industry to reduce EO emissions, in response to recent sterilization plant shutdowns that disrupted the medical device supply chain. In February 2019, the Illinois EPA shut down an EO sterilization facility in Willowbrook, IL, following public demonstrations protesting the plant’s EO emissions. Additional EO sterilization plants shut down in other states in the following months.

Because EO is the most common method of sterilization for medical devices in the United States, and most plants were operating at near full capacity, the shutdowns led to shortages of medical devices in the United States.

Topic Discussed: Medical Device Makers See Progress in EO Sterilization

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