AUDIENCE: Risk Manager, Pulmonology, Otolaryngology, Cardiothoracic Surgery
ISSUE: The FDA has undertaken an ongoing, comprehensive investigation into infections associated with reprocessed reusable medical devices, working with federal partners, manufacturers, and other stakeholders to better understand the critical factors contributing to device-associated patient infection and how to best mitigate them.
In the March 2015 Reprocessing Final Guidance, FDA 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, so FDA is proactively investigating these devices to determine if additional steps should be taken. As part of that investigation, 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.
While not every medical device report contains information sufficient to definitively identify the factors contributing to persistent device contamination or device-associated infection, 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.
BACKGROUND: Bronchoscopes must undergo reprocessing in between patient uses to clean the devices of soil and contaminants and to inactivate microorganisms by disinfection or sterilization. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. If the process is not followed meticulously, the flexible bronchoscope can remain contaminated, potentially resulting in infection transmission from one patient to the next.
RECOMMENDATION: 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 for recommendations regarding bronchoscope reprocessing.
See the FDA Safety Communication for additional information.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[09/17/2015 - Safety Communication - FDA]