The U.S. Food and Drug Administration has updated a safety communication on reprocessed flexible bronchoscopes that is supported by Columbia-based Ambu. The FDA recommends that health care providers consider using single-use bronchoscopes where there is increased risk of spreading infection or no support for immediate reprocessing available.
Additionally, the FDA recommends health care facilities consider using sterilization for reprocessing instead of high-level disinfection. This latest update follows recent recommendations from the American Association for Bronchology and Interventional Pulmonology on treating COVID-19 patients.
The FDA communication also summarizes 867 medical device reports (MDRs) submitted to the agency from 2015-2021 related to infections or device contamination associated with reusable flexible bronchoscopes — an almost eight-fold increase from the 109 MDRs received by the FDA from 2010-2015. The FDA safety communication was first issued in 2015 and drew attention to reprocessing failures as well as continued use of devices with mechanical and maintenance issues.
In April 2021, the FDA announced new investigations into more than 450 medical device reports describing patient infections and other possible contamination issues related to urological endoscopes and sent a letter cautioning healthcare providers of the risk of infections associated with reprocessing urological endoscopes.
Ambu believes the FDA recommendation will improve patient safety during bronchoscopy procedures and that single-use products can play an important role to support the new guidelines; and that any patient that enters the operating room or intensive care unit should not be exposed to further risk of infection.
The FDA recommendation for health care systems to move to sterilization of reusables also further increases the economic attractiveness of single-use bronchoscopy and will accelerate the transition to make single-use bronchoscopy the standard of care.