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Risk Of Sterilization Plant Shutdowns Across US Sends Shockwave Through Industry

Executive Summary

While a number of US states are taking actions that could potentially ban or limit ethylene oxide (EtO) sterilization plants in their communities, the FDA, industry and others are raising the alarm that such moves could lead to a shortage of medical devices critical to patients.

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Another Sterilization Plant Closes For Upgrades; FDA Monitoring Situation For Device Shortage

The US agency is engaged with an ethylene oxide (EtO) sterilizer in Illinois that has temporarily closed to determine if there are any potential risks to the medical device supply chain. While the plant shut down about a month ago, regulators have only recently been made aware of the decision, which resulted from a law passed last year by the state legislature.

FDA Launches Pilot Program To Streamline EtO Facility, Process Changes

As concerns continue to mount over a potential shortage of medical devices due to the closure of ethylene oxide (EtO) facilities, the US agency is looking for nine sterilizers in a pilot project that could allow them to get facility and process changes approved faster.

US FDA Experts Caution Against Banning EtO, Encourage More Duodenoscope Training

Health-care experts are concerned about the potential public risk posed by ethylene oxide emissions but said banning the sterilizing agent without a backup plan is likely to have devastating effects. Recently recorded deaths due to duodenoscope infections has been concerning, but the experts put the blame on inadequate cleaning of the device by staff members rather than on the device itself. The solution, they find, is a better trained workforce.

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