FDA releases interim results for duodenoscope reprocessing studies

Feb. 26, 2019

In December 2018, the U.S. Food and Drug Administration (FDA) released its “Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings: FDA Safety Communication.” The results showed higher-than-expected contamination rates with duodenoscopes after reprocessing. Facilities and staff that reprocess duodenoscopes are reminded of the importance of manual cleaning prior to disinfection or sterilization, as well as the need for proper servicing of duodenoscopes.

Duodenoscopes contain many small working parts. If reprocessing instructions are not followed in every step of the process, tissue or fluid from one patient can remain in the instrument and be used on a subsequent patient; in rare cases, this can lead to patient-to-patient infection transmission.

At least 10 percent of the samples have been collected for the FDA’s sampling and culturing studies. The studies were designed assuming less than a 0.4 percent contamination rate. Interim results from these studies revealed that up to 3 percent of properly-collected samples tested positive for enough low-concern organisms to indicate a reprocessing failure and up to 3 percent of properly-collected samples tested positive for high-concern organisms. High-concern organisms are defined as organisms that are more often associated with disease, such as E. coli and Pseudomonas aeruginosa. Root cause analyses are currently underway to better understand these culturing results. Some factors that may contribute to device contamination after reprocessing include device damage and errors in reprocessing. These results are preliminary; final results are expected sometime in 2019.

The FDA recommends facilities and staff strictly adhere to the manufacturer’s reprocessing and maintenance instructions and follow these best practices:

  • Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using an automated endoscope reprocessors (AERs). Raise and lower the elevator throughout the manual cleaning process to allow brushing and flushing of both sides. After cleaning, carefully inspect the elevator recess and repeat cleaning if any soil or debris is visible.
  • Implement a comprehensive quality control program for reprocessing duodenoscopes. The 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.
  • Follow the duodenoscope manufacturer’s recommendations for inspection, leak testing and maintenance of the duodenoscope.
    • Prior to each use, each scope should be closely inspected for damage, as recommended in the duodenoscope instruction manuals. Examples of damage may include loose parts; protrusions or abnormal bulging from the endoscope; kinks or bends in tubing; cracks and gaps in the adhesive that seals the device’s distal cap; and more. If a scope shows any signs of wear or damage, it should be removed from service for assessment, and then repaired or replaced.
    • During each reprocessing cycle, leak testing should be performed. It is essential to follow the duodenoscope manufacturer’s leak testing instructions for angulating the bending section and elevator during leak testing. Duodenoscope that show signs of leakage should be removed from service for assessment, and then repaired or replaced.
    • As recommended in the duodenoscope instruction manuals, the duodenoscope should be sent to the duodenoscope manufacturer for inspection, servicing and maintenance at least once per year or as needed.

The FDA continues to track cases of infection with multi-drug resistant bacteria and the use of duodenoscopes through medical device adverse event reports submitted to the FDA, literature and stakeholders feedback. Additionally, the agency is working with healthcare facilities and reprocessing personnel to better understand their experiences in implementing reprocessing protocols; working with companies to modify the reprocessing instructions to enhance the safety margin of methods used to clean, disinfect and sterilize duodenoscopes; and encouraging the development of new technology and design features, such as disposable components, to enhance patient safety, especially when a life-saving procedure such as identifying cancer by ECRP is necessary. The FDA notes it will continue to provide additional information to the public as new information becomes available.