FDA posts safety alert on reprocessed flexible bronchoscopes.

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 processed. The FDA is proactively investigating these devices to determine if additional steps should be taken.

As part of the investigation, the FDA observed commonalities in some of the reports regarding infections linked to flexible bronchoscopes. On the basis of current knowledge, the risk of infection transmission appears to be lower than the risk of infection transmission presented by reprocessed duodenoscopes.

Precautions recommended by the FDA include:

• strictly adhere to manufacturer’s reprocessing instructions
• immediately remove from service any bronchoscope that fails a leak test or shows signs of damage
• follow manufacturer’s recommendation 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.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm462979.htm