9/23/15

Bronchoscopes: A Risk for Infection?


By on 6:02 AM

On September 17, the U.S. Food and Drug Administration (FDA) released a safety communication statement to healthcare professionals that shares preliminary information regarding reprocessed flexible bronchoscopes and the possibility of infections associated with use of these devices.

The statement was released less than a week after the FDA, along with the Centers for Disease Control and Prevention (CDC), released a Health Advisory that urged healthcare facilities utilizing reusable medical devices to immediately review current reprocessing practices.

In light of this and other recent undertakings by the federal government related to addressing the challenges of reprocessing endoscopes and duodenoscopes to avoid transmission of bacteria from patient to patient, it is imperative for healthcare facilities to understand that the reprocessing of bronchoscopes also requires a detailed, multistep process to ensure they are properly cleaned and disinfected or sterilized. If the process is not followed meticulously, the flexible bronchoscope can remain contaminated, potentially resulting in infection transmission during bronchoscopy procedures.

The FDA published the following information: "In our March 2015 Reprocessing Final Guidance, we 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 we are proactively investigating these devices to determine if additional steps should be taken. As part of that investigation, we have observed commonalities in some of the reports to the FDA regarding infections associated with flexible bronchoscopes."

While the risk of infection from bronchoscopes appears to be lower than gastrointestinal-related scopes such as duodenoscopes, commonalities exist with respect to a breakdown in processes. The FDA highlights two recurrent themes: "failure to meticulously follow manufacturer instructions for reprocessing" and "continued use of devices despite integrity, maintenance and mechanical issues."

The FDA recommends that facilities reprocessing 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.
  • Do not skip steps. Be sure to follow all pre-cleaning, manual cleaning and HLD or sterilization steps.
  • Ensure that staff who reprocess soiled bronchoscopes understand the importance of manually cleaning the scope thoroughly before it is disinfected or sterilized. Meticulous cleaning is an essential part of endoscope reprocessing. Failure to perform adequate cleaning may result in failure of HLD or sterilization.
  • Use only bronchoscope manufacturer-specified cleaning accessories, high-level disinfectants, enzymatic cleaning agents and detergents and follow their directions for use.
  • 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.

If you have questions about the FDA Safety Communication or require assistance with ensuring your facility follows proper reprocessing procedures, contact Phenelle by filling out the form here, emailing info@iccs-home.com or calling (215) 692-3485.

Phenelle Segal, RN, CIC

Phenelle Segal, RN, CIC, FAPIC, is the founder and president of Infection Control Consulting Services LLC (ICCS). Phenelle has more than 30 years experience providing customized comprehensive infection control and prevention services to healthcare facilities nationwide. Her services focus on assisting hospitals, ambulatory surgery centers, dental office and oral surgery practices, doctor's offices, nursing homes and other organizations with implementing and maintaining an infection control program that: complies with The Joint Commission, AAAHC, Centers for Medicaid and Medicare Services (CMS) and other regulatory agencies; respond to situations of noncompliance; and improve the processes for reducing risk.

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