FDA posts safety alert on reprocessed flexible bronchoscopes

Editor's Note

The Food and Drug Administration (FDA) has identified bronchoscopes as a subset of devices that pose a greater likelihood of microbial transmission and represent a high risk of infection if not adequately reprocessed.

The FDA is proactively investigating these devices to determine if additional reprocessing steps should be taken. Based on current knowledge, the risk of infection transmission appears to be lower than that of reprocessed duodenoscopes.

Precautions recommend by the FDA include:

• strict adherence to manufacturer’s reprocessing instructions
• immediately remove from service any bronchoscope that fails a leak test or shows signs of damage
• follow manufacturer’s recommendations for preventive maintenance and repair of the device
• implement a comprehensive reprocessing quality control program
• store bronchoscopes in a manner that will minimize the likelihood of contamination or collection of moisture.

Posted 09/17/2015] AUDIENCE: Risk Manager, Pulmonology, Otolaryngology, Cardiothoracic Surgery ISSUE: The FDA has undertaken an ongoing, comprehensive investigation into infections associated with reprocessed reusable medical devices, working with federal partners, manufacturers, and other stakeholders to better understand the critical factors contributing to device-associated patient infection and how to best mitigate them.