FDA issues safety recommendations for bronchoscope reprocessing

The Food and Drug Administration today issued safety recommendations for health care facilities that reprocess flexible bronchoscopes. The agency said facilities and staff should strictly adhere to the manufacturer’s reprocessing instructions, and immediately remove from service any bronchoscope that fails a leak test (performed to assess scope integrity after every procedure) or shows visible signs of damage. Facilities also should follow the manufacturer’s recommendations for preventive maintenance and repair; implement a comprehensive reprocessing quality control program; and store bronchoscopes in a manner that will minimize the likelihood of contamination, the agency said. A flexible bronchoscope is a thin, lighted tube threaded through the nose or mouth to examine a patient’s throat, larynx, trachea or lower airways. The recommendations are based on the agency’s analysis of 109 reports concerning infections or contamination associated with the devices since 2010. FDA encourages health care providers to report infections or suspected contamination related to bronchoscope use to the FDA MedWatch program.