The United States Food and Drug Administration (FDA) has issued an alert that identified bronchoscopes as being part of a subset of devices that pose a greater likelihood of microbial transmission and represent a high risk of infection if they are not adequately reprocessed.
The FDA observed commonalities in some of the reports to the FDA regarding infections associated with flexible bronchoscopes. Based on current knowledge, the risk of infection transmission presented by reprocessed bronchoscopes appears to be lower than the risk of infection transmission presented by reprocessed duodenoscopes.
The FDA analysis to date has identified two recurrent themes:
- Failure to meticulously follow manufacturer instructions for reprocessing
- Continued use of devices despite integrity, maintenance and mechanical issues
The FDA recommends that facilities that reprocess flexible bronchoscopes take the following precautions:
- Strictly adhere to the manufacturer's reprocessing instructions. It is critical that staff responsible for reprocessing bronchoscopes have the manufacturer's instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling.
- Immediately remove from service for assessment and repair or replace any bronchoscope that fails a leak test (performed to assess scope integrity after every procedure), or shows visible signs of damage. Examples of damage may include: loose parts, damaged channel walls, kinks or bends in tubing, holes in the distal end, or other signs of wear or damage.
- Follow the manufacturer's recommendations for preventive maintenance and repair of the device. For additional information on maintenance and repair services, refer to the manufacturer's information provided with your bronchoscope or directly contact the manufacturer.
- Implement a comprehensive reprocessing quality control program. Your reprocessing program should include written procedures for monitoring, training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure.
- 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.
- Refer to the American College of Chest Physicians and American Association for Bronchology Consensus Statement: Prevention of Flexible Bronchoscopy-Associated Infection: 2005 disclaimer icon for recommendations regarding bronchoscope reprocessing.
For details, please refer to the FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm462979.htm
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm462949.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 September 2015