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Podcast: 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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Medtronic’s Phil Cogdill brought a sterilized oxygenator used in cardiac surgery to a US agency meeting on ethylene oxide (EtO) to show experts how difficult it is to clean such lifesaving products • Source: Ferdous Al-Faruque

Phil Cogdill, director of quality sterilization and microbiology at Medtronic, spoke before a panel of experts about the importance of setting new ethylene oxide (EtO) standards to clean medical devices. While it may take years for such standards to fully go into effect, he and other experts have already rolled up their sleeves to get the job done.

The US Food and Drug Administration kicked off a two-day meeting on 6-7 November in Gaithersburg, MD, to discuss how to respond to recent EtO sterilization plant closures that the agency is concerned could lead to a device shortage. A member of the standards organization Association for the Advancement of Medical Instrumentation (AAMI), Cogdill spoke before the General Hospital and Personal Use Devices Panel to argue that the industry should move away from what is called the Overkill Method that uses and releases excess EtO

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