FDA Warns of Infection Risk Posed by Flexible Bronchoscopes

The FDA is providing additional tips on how to reduce the risk of transmitting antibiotic-resistant infections through the proper reprocessing of flexible bronchoscopes — instruments used to check a patient’s airways.

Failure to follow manufacturer instructions for reprocessing, as well as the repeated use of bronchoscopes that have integrity, maintenance or mechanical issues, continue to pose patient safety challenges, according to a safety notice issued by the agency last week.

The FDA came to this conclusion as a result of an ongoing investigation into infections associated with reprocessed reusable devices, including the complex duodenoscope. That device has been associated with infections resistant to antibiotic treatment.

A flexible bronchoscope is threaded through a patient’s nose or mouth to allow a physician to examine the throat, larynx, trachea and lower airways. The FDA estimates there are about 500,000 bronchoscopy procedures performed in the U.S. annually.

In March, the FDA unveiled final guidance strengthening controls on reprocessing. At the time, it said bronchoscopes can pose a greater risk to patients if reprocessed improperly. However, the FDA has acknowledged the risk of infection transmission is lower with bronchoscopes than with duodenoscopes (IDDM, March 13).

To ensure patient safety, the agency is making the following recommendations for healthcare providers:

• Strictly adhere to manufacturers’ reprocessing instructions;
• Remove any bronchoscope from service that fails the leak test for service and assessment of visible signs of damage;
• Follow the manufacturer’s recommendations for preventive maintenance and repair of the device;
• Implement a comprehensive reprocessing quality control program to include written procedures for monitoring, training and adherence;
• Store bronchoscopes in a manner that will minimize the likelihood of contamination or collection and retention of moisture, according to manufacturer’s instructions; and
• 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.

The safety notice is available here www.fdanews.com/092115-safety-notice.pdf. — Elizabeth Hollis