Endoscope Final Guidance Calls For Backflow Prevention
Executive Summary
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.
You may also be interested in...
US FDA wants reusable device makers to validate reprocessing instructions
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.
To Mitigate Endoscope Contamination Risk, Stop Backflows And Reprocess, FDA Says
A draft guidance recommends prevention of backflow in flexible gastrointestinal endoscopes and reprocessing or discarding endoscopic devices with distal one-way valves to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.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.