CPS Safety Watch/Alert: Reprocessed Flexible Bronchoscopes Pose Risk

October 9, 2015    |   By: Calevir

PSOAlert!On September 17, 2015 the FDA issued a safety communication on “Infections Associated with Reprocessed Flexible Bronchoscopes”, following its earlier communication about similar concerns with duodenoscopes/endoscopes.
This alert is to reinforce the following highlights of the report, encouraging healthcare
providers to review processes and implement steps to ensure the safety of patients:

  • Bronchoscopes are a subset of devices that pose a high risk of infection if not adequately reprocessed.
  • Between January 2010 and June 2015 the FDA received 109 Medical Device Reports (MDRs) concerning infection/device contamination associated with flexible bronchoscopes.
  • In 2014 alone the FDA received 50 MDRs concerning infection/device contamination associated with flexible bronchoscopes that prompted further investigation.
  • A small number of MDRs document device contamination despite following manufacturer’s reprocessing instructions. These reports are still being investigated.

The complete report is available here.

The earlier published FDA communications addressed concerns about:

  • The complex design of ERCP endoscopes (duodenoscopes) providing a challenge to cleaning and high-level disinfection.
  • Potential for residual body fluids/organic debris to remain in the microscopic crevices of the moving parts of the elevator mechanism and expose patients to serious infections.
  • Seventy-five MDRs received between January 2013 and December 2014 related to potential microbial transmission from reprocessed endoscopes/duodenoscopes.
  • Instances of device contamination despite strict adherence to manufacturer’s reprocessing instructions.

Complete information from the FDA on these concerns are available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm and http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm454766.htm.

MITIGATION STRATEGIES TO CONSIDER

  • Strict adherence to the manufacturer’s reprocessing instructions
  • Immediate removal of use of any bronchoscope that fails a leak test or shows visible signs of damage
  • Conduct maintenance and repair according to manufacturer’s recommendations
  • Implement a comprehensive reprocessing quality control program
  • Store bronchoscopes in a manner so as to minimize the risk of contamination

RESOURCES TO TAKE ACTION

CDC/FDA Health Update about the Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices:  http://emergency.cdc.gov/han/han00383.asp.

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