FDA Updates Recommendations for Duodenoscope Reprocessing

The U.S. Food and Drug Administration (FDA) has issued a safety communication drawing attention to the ongoing challenge of effective cleaning and disinfection of duodenoscopes between their uses.

The safety communication shares the results of preliminary surveillance studies performed by the three U.S. duodenoscope manufacturers: Olympus, Fujifilm and Pentax. The studies — one to sample and culture reprocessed duodenoscopes in clinical use to characterize contamination rates and learn more about issues that contribute to contamination (sampling study) and one to assess how effectively the trained hospital staff follow the manufacturer reprocessing instructions (human factors study) — are intended to determine whether healthcare facilities are able to properly clean and disinfect the devices.

Concerning the preliminary findings of the sampling studies, FDA states:

"Interim results from these studies indicate higher-than-expected contamination rates after reprocessing, with up to 3% of properly collected samples testing positive for enough low concern organisms to indicate a reprocessing failure and up to 3% of properly collected samples testing 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."

Concerning the preliminary findings of the human factors studies, FDA states:

"… results indicate that reprocessing instructions in current user manuals are difficult for reprocessing staff to comprehend and follow. For example, some reprocessing staff missed one or more steps in the process and needed additional training to complete the process properly. The study revealed that the descriptions of some of the processing steps in the user manuals were unclear. As a result, the FDA is working with the duodenoscope manufacturers to revise and clarify the user materials to improve comprehension and adherence to reprocessing instructions."

Revised Duodenoscope Recommendations

Since the study results revealed unexpectedly higher contamination rates, FDA provided updated recommendations for steps healthcare providers can take to enhance duodenoscope reprocessing. They include the following:

  • Facilities and staff should strictly adhere to the manufacturer's reprocessing and maintenance instructions.

  • Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using an automated endoscope reprocessor. 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. Include in it 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, closely inspect and remove from service for assessment, and repair or replace any duodenoscope that shows visible signs of damage.

    • During each reprocessing cycle, conduct leak testing and remove from service for assessment, and repair or replace any duodenoscope that shows signs of leakage.

    • Follow the duodenoscope manufacturer's leak testing instructions for angulating the bending section and elevator during leak testing.

    • Return the duodenoscope to the duodenoscope manufacturer for inspection, servicing and maintenance of the device at least once per year.

FDA also highlighted its previously issued safety communication that provides a detailed list of supplemental duodenoscope reprocessing measures (e.g., microbiological culturing, sterilization, use of a liquid chemical sterilant processing system, repeat high-level disinfection) that can be implemented to reduce the risk of infection transmission. 

In March, FDA issued warning letters to the duodenoscope manufacturers concerning their failure to fully comply with a federal order to conduct the postmarket surveillance studies.