Infections Associated with Reprocessed Bronchoscopes

The FDA issued a warning on infections associated with reprocessed flexible bronchoscopes.

Based on its preliminary investigation, the FDA said the risk of infection presented by reprocessed bronchoscopes appears to be lower than the risk of infection presented by reprocessed duodenoscopes.

Last year, reprocessed endoscopes caught the FDA’s attention due to numerous antibiotic-resistant infections reported. As a result, the agency issued final guidance in March 2015 strengthening controls on reprocessing (IDDM, March 16, 2015).

Noting recurrent issues, the agency said the same procedures for reprocessing should be applied to bronchoscopes:

• Strictly adhere to manufacturer’s reprocessing instructions;
• Immediately remove from service for assessment and repair or replace any bronchoscopes that fail a leak test;
• Follow the manufacturer’s recommendations for preventive maintenance and repair of the device;
• Implement a comprehensive reprocessing quality control system; and
• After reprocessing, store bronchoscopes in a manner that will minimize the likelihood of contamination.

Read the safety notice here: www.fdanews.com/09-22-16-safetyalert.pdf. — Tamra Sami