FDA Issues Recommendations To Reduce Bronchoscope Infection Risk

By Jof Enriquez,
Follow me on Twitter @jofenriq

The U.S. Food and Drug Administration (FDA) said recently that it is investigating reports of infection cases linked to the use of reprocessed bronchoscopes. In response, FDA has issued new recommendations for facilities and health workers on how to reprocess the devices to limit the risk of contamination more effectively.

Bronchoscopes are the latest instrument subject to an ongoing inquiry by the FDA, with input from manufacturers and stakeholders, investigating infections associated with a range of reprocessed and reusable medical devices. An estimated 500,000 bronchoscopy procedures are performed annually in the U.S. to diagnose conditions affecting the airways and lungs.

The Los Angeles Times reports that the FDA has analyzed 109 medical device reports, dated between January 2010 and June 2015, pertaining to infections or device contamination. Almost half, 50 reports, were filed last year alone, triggering the investigation. The agency says initial analysis indicates the risk of infection posed by bronchoscopes was lower compared to that of duodenoscopes, which were linked to Carbapenem-resistant Enterobacteriaceae (CRE) outbreaks earlier this year.

Accordingly, FDA has not pulled bronchoscopes from the market, noting that benefits of their use outweigh the risks.

According to a safety communications alert, FDA investigators found two recurrent factors that may help explain infections by bronchoscopes: Failure to meticulously follow manufacturer instructions for reprocessing, and continued use of devices despite integrity, maintenance, and mechanical issues.

"Bronchoscopes must undergo reprocessing in between patient uses to clean the devices of soil and contaminants and to inactivate microorganisms by disinfection or sterilization," states the FDA alert. "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."

Although the factors identified by investigators suggest a failure on the part of facility staff to observe proper reprocessing protocol, the FDA says a small number of incident reports indicate “persistent device contamination despite following the manufacturer's reprocessing instructions,” according to the LA Times.

Lawrence Muscarella, a hospital-safety consultant in Montgomeryville, Pa., suggests that product design, as much as staff shortcomings, may be among the main reasons behind contamination. 

“If we are transmitting CRE from bronchoscopes, it means hospitals are not doing an adequate job of manually cleaning and it could also mean the manufacturers' design of bronchoscopes should be enhanced,” Muscarella told the LA Times. “The jury is still out on what is causing these outbreaks.”

When it released final guidance on reprocessing of reusable medical devices in March, the FDA recommended manufacturers more thoroughly test and label devices to indicate strict reprocessing procedures.

"The guidance also recommends that manufacturers consider reprocessing challenges early in device design. Manufacturers will be expected to conduct validation testing to show with a high degree of assurance that their cleaning and disinfection or sterilization instructions will consistently reduce microbial contamination," the FDA stated in an accompanying press release.

In the recent safety warning, the FDA recommends facilities perform the following actions to mitigate the risk of contamination from bronchoscopes:

• Have manufacturer's reprocessing instructions readily available and strictly follow them.
• Remove from service or send for repair devices which fail a leak test or show visible signs of damage (e.g., loose parts, damaged channel walls, kinks or bends in tubing, holes in the distal end, etc.).
• Follow the manufacturer’s recommendations for preventive maintenance and repair of the device.
• Implement a comprehensive reprocessing quality control program that includes written procedures for monitoring, training, and adherence to the program, as well as documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure.
• Store bronchoscopes in a manner that will minimize the likelihood of contamination or collection and retention of moisture, according to manufacturer’s instructions.

"We are proactively investigating [bronchoscopes] to determine if additional steps should be taken,” stated the FDA to the LA Times.