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Ethylene oxide sterilization facilities: Where are we now?

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Three medtech sterilization plants have been closed, and another facility is currently in talks about potentially shutting down.

Why are the facilities being shut down?

The reason for the closures is because the Environmental Protection Agency (EPA) considers the levels of Ethylene Oxide (EO), which is a carcinogen, to be too high at these facilities.

Why is this important for manufacturers?

According to the FDA, 50% of all devices which are sold within the United States and require sterilization, are sterilized using EO. EO is a popular sterilization method due to its penetration properties and ability to leave products undamaged during the process.

What does the FDA advise?

The organization are identifying alternative sterilization methods and ways to reduce the amount of EO needed to sterilize devices.

At the end of last year the FDA in a statement issued on the topic: “The FDA will continue in our steadfast commitment to develop solutions to avoid potential device shortages and encourage new, innovative ways to sterilize medical devices while reducing adverse impacts on the environment and on the public health." The full statement can be read on their website.

Earlier this year, however, the FDA published an updated statement on the issue. The organization stated it is, "closely monitoring the supply chain effects of closures and potential closures of certain facilities that use ethylene oxide to sterilize medical devices prior to their use."

The FDA asks healthcare providers, consumers and medical device manufacturers to contact the FDA regarding any delays or shortages with medical products as a result of facility closures due to EO. The organization also provides an updated list on the facilities which are closed, temporarily closed or in talks about being closed. This includes:

The full statement issued by the FDA in January this year can be viewed here.

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