[Posted 09/17/2015]

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:

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]