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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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.
Listen: Medtronic Exec Highlights Ethylene Oxide Standards At First Day Of FDA EtO Meeting
Medtronic’s director of quality sterilization and microbiology, Phil Cogdill, sat down with Medtech Insight to talk about setting new ethylene oxide (EtO) standards and what his takeaways were from the first day of a US FDA meeting to understand how to mitigate potential product shortages from closures of EtO sterilization facilities. Check out our podcast here.
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