FDA releases guidelines for reprocessing bronchoscopes

Patient Safety Monitor Insider

September 23, 2015

In the wake of recent outbreaks related to contaminated devices, the Food and Drug Administration (FDA) last week issued new safety recommendations for healthcare facilities that reprocess flexible bronchoscopes. There have been 109 reports of infections or contamination associated with bronchoscopes since 2010, according to AHA News. The scopes are threaded through a patient’s nose or mouth to examine the throat, larynx, trachea, or lower airways.

The FDA said facilities should adhere closely to the device manufacturer’s reprocessing instructions. If a bronchoscope fails a leak test or has visible signs of damage, it should be removed from service immediately. Facilities should also follow manufacturers’ recommendations for preventive maintenance and repair, implement a reprocessing quality control program, and ensure proper storage of the scopes to prevent contamination.

Read the FDA announcement.