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.
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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.