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FDA Update On Heater-Cooler Devices Seeks New Designs To Reduce Infections

 
• By Brian Bossetta

The US FDA has published updated information on heater-cooler devices used to warm or cool patients during surgery, which says the agency is working with industry to bring to market innovative devices that lower the risk of bacterial infection.

FDA Man Behind Screen
• Source: Shutterstock

In 2017, the Food and Drug Administration updated its 2015 guidance, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,” to include water-based heater-cooler devices used in surgery to keep patients warm or cool.

Since then, the agency says it has been working with industry to bring innovative heater-coolers to market to lessen the...

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• By Amanda Maxwell

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Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 
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