Endoscope Final Guidance Calls For Backflow Prevention
Irrigation accessories used with endoscopes pose a risk of cross-contamination when used on multiple patients. An FDA final guidance will require these devices to include a backflow-prevention valve to mitigate the risk.
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The US Food and Drug Administration has issued final guidance to help manufacturers of reusable medical devices develop safer products, especially those that pose a greater risk of infection1-3.
A draft guidance recommends prevention of backflow in flexible gastrointestinal endoscopes and reprocessing or discarding endoscopic devices with distal one-way valves to mitigate cross-contamination risks.
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