FDA finds higher than expected contamination rates after duodenoscope reprocessing: Best practices for avoiding fines

The FDA found higher than expected contamination rates after duodenoscope reprocessing, to the extent that up to 3 percent of scopes were considered "reprocessing failures."

On Oct. 5, 2015, the FDA ordered duodenoscope manufacturers Olympus, Fujifilm and Pentax to conduct postmarket surveillance studies to determine whether duodenoscopes were properly reprocessed in real-world settings. The companies conducted one study to sample and culture the reprocessed duodenoscopes and one "human factors" study to determine how well staff follow reprocessing instructions. 

At least 10 percent of the samples have been collected for the sampling and culturing studies, which were designed assuming a contamination rate of less than 0.4 percent.

According to preliminary results from the FDA's postmarket surveillance studies:

  • 3 percent of properly collected samples tested positive for more than 100 colony-forming units of organisms that are unlikely to cause serious infections but indicate a reprocessing failure
  • 3 percent of properly collected samples tested positive for "high-concern" organisms most commonly associated with disease such as E. coli and Pseudomonas aeruginosa

The companies are now conducting root cause analyses to understand these interim results. According to the FDA, device damage and reprocessing errors may have contributed to device contamination.

Preliminary results from the human factors studies indicate reprocessing instructions in current user manuals are difficult for reprocessing staff to understand and follow. Some reprocessing staff missed one or more steps in the process and needed additional training to complete the process properly. The FDA is collaborating with the manufacturers to revise and clarify the user materials.

The FDA recommends healthcare facilities using duodenoscopes follow manufacturer reprocessing instructions and consider implementing supplemental reprocessing measures to reduce infection transmission risk, such as microbiologic culturing, sterilization, use of a liquid chemical sterilant processing system and additional high-level disinfection.

Healthcare facilities should follow these best practices:

  1. Carefully inspect the elevator recess and repeat cleaning if any soil or debris is visible.
  1. Users should follow the manufacturer's recommendations for inspection, leak testing and duodenoscope maintenance and return the duodenoscope to the manufacturer at least once a year for inspection, servicing and maintenance.
  1. Providers should participate in manufacturers surveillance sampling and culturing', and consider initiating their own sampling and culturing program to reduce the infection risks.

The FDA relies on manufacturers to report infections and other adverse events associated with duodenoscopes in a timely fashion – generally within 30 days of learning about the event.

When this does not occur, the FDA and other entities take punitive action. In 2017, Washington state jurors ordered Olympus to pay Seattle-based Virginia Mason Medical Center $6.6 million after a patient contracted an infection because of an improperly cleaned duodenoscope. The FDA's Office of Criminal Investigations recently worked with the U.S. Department of Justice to bring criminal action against Olympus for failing to adequately file adverse event reports involving infections associated with their TJF-Q180V duodenoscope. After pleading guilty to three counts of distributing misbranding devices in interstate commerce, Olympus was fined $80,000,000 and ordered to forfeit $5,000,000.  As part of its plea agreement with the DOJ, the company is also subject to enhanced compliance measures.

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