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FDA Issues Warning For Infection Risk With Reprocessed Flexible Bronchoscopes

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Washington, DC: In the March 2015, the FDA identified bronchoscopes as being part of a subset of devices that pose a greater likelihood of microbial transmission and represent a high risk of infection if they are not adequately reprocessed. As a result, The FDA has undertaken an ongoing, comprehensive investigation into infections associated with reprocessed reusable medical devices, to better understand the critical factors contributing to device-associated patient infection and how to best mitigate them.

As part of that investigation, FDA observed commonalities in some of the reports to the FDA regarding infections associated with flexible bronchoscopes. Based on current knowledge, the risk of infection transmission presented by reprocessed bronchoscopes appears to be lower than the risk of infection transmission presented by reprocessed duodenoscope .

Bronchoscopes must undergo reprocessing in between patient uses to clean the devices of soil and contaminants and to inactivate microorganisms by disinfection or sterilization. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. If the process is not followed meticulously, the flexible bronchoscope can remain contaminated, potentially resulting in infection transmission from one patient to the next.



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