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Latest From Ferdous Al-Faruque
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.
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.
The medical device-maker says it will lose millions by the end of the fiscal year because Georgia regulators have temporarily shut down Sterigenics’ ethylene oxide sterilization (EtO) facility near Atlanta. With no news on when it will reopen, the company says it may lose even more money next year.
The White House has announced President Trump’s intent to nominate MD Anderson’s Stephen Hahn as the next FDA commissioner. The position has been held by acting commissioner Ned Sharpless for the past seven months. Admiral Brett Giroir will helm the agency on an acting basis until the new commissioner is confirmed.
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.
BD, State Of Georgia Agree To Allow EtO Sterilization Plant To Keep Operating, Averting Potential Device Shortage
The state’s environmental regulators agreed on 28 October to allow Becton Dickinson to continue sterilizing medical devices using ethylene oxide (EtO) as long as the company continues to make modifications to their sterilization plants in the state, and limit the number of devices they sterilize. The agreement may have averted a serious medical device shortage across the US.