FDA Updates Recommendations for Reprocessing Reusable Flexible Bronchoscopes
By: Randolph Fillmore
July 14, 2021
Categories: AAMI News, Sterilization Professionals
Due to an increasing number of Medical Device Reports (MDRs) regarding infections caused by—or contamination of—reusable flexible bronchoscopes, the FDA has released updated device recommendations as a supplement to its 2015 safety communication regarding reprocessing these devices.
“The FDA is reminding healthcare facilities and staff responsible for reprocessing bronchoscopes and their accessories about the importance of carefully following the manufacturer's reprocessing instructions,” the FDA wrote.
The number of MDRs reported to the FDA rose from 109 between January 2010 and June 2015 to 867 for the period of July 2015 and January 2021. Seven deaths related to device contamination were also reported between 2015 and 2021. Approximately 500,000 bronchoscopy procedures are performed annually in the U.S, according to the agency.
The FDA’s update, directed to healthcare facilities and staff as well as patients and caregivers, covers reusable flexible bronchoscopes with a thin, flexible lighted tube that can be inserted through the nose, mouth, or other access points, such as a tracheotomy.
Recommendations for healthcare facilities and staff responsible for reprocessing bronchoscopes include:
- Use of sterilization instead of high-level disinfection, where possible, “because sterilization has a greater safety margin than high-level disinfection.”
- If using high-level disinfection, “disinfection steps should include precleaning, leak testing, cleaning, high-level disinfecting, rinsing with tap or utility water followed by alcohol flushing or with critical (filtered or sterile) water, and drying.”
- Use only manufacturer-specified cleaning accessories, high-level disinfectants, enzymatic cleaning agents, and detergents.
- After reprocessing store bronchoscopes in a manner “that will minimize the likelihood of contamination or collection and retention of moisture, according to manufacturer's instructions”
- Follow the manufacturer's recommendations for preventive maintenance and repair of the device and accessories.
- Develop schedules for routine inspection and periodic maintenance in accordance with the manufacturer's instructions.
- Do not reprocess or reuse single-use bronchoscopes.
The FDA also recommended inspecting bronchoscopes for loose parts; damaged channel walls; kinks or bends in tubing; holes, cracks, or imperfections in the distal ends; and other signs of wear or damage.
FDA said healthcare personnel employed by facilities subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.