Dive Brief:

• FDA has seen a higher-than-expected rate of duodenoscope contamination in post-marketing studies of the devices, which diagnose and treat problems with the bile duct and pancreas. 

• Across studies run by Olympus, Fujifilm and Pentax, 6% of sampled duodenoscopes were contaminated with microorganisms including pathogenic strains such as E. coli. In response, the three manufacturers are performing root cause analyses of the problems and FDA is working with them to clarify user materials to improve cleaning of the devices.

• Olympus and a former senior executive pleaded guilty for not reporting adverse events related to duodenoscope infections, the U.S. Department of Justice announced Monday. The company has been fined $80 million, with an additional $5 million in criminal forfeiture based on a plea agreement with DOJ.

Dive Insight:

FDA signaled its concern about the risk of duodenoscope contamination in 2015 when it ordered Olympus, Fujifilm and Pentax to run post-market studies of their devices. The order came in the year that duodenoscope medical device reports associated with infections peaked at 250. In light of the rise in apparent cases of contamination, FDA wanted to know how prevalent the problem was and how user materials contributed to reprocessing failures.

The order initially failed to trigger the desired response from the manufacturers, leading FDA to hit all three with warning letters in March. The warning letters chastised the manufacturers for failing to provide enough data to meet their reporting requirements.

Having encouraged the manufacturers to step up their generation of post-market data, FDA now has enough information to perform a preliminary analysis. The analysis is based on more than 10% of the samples in the culturing trials, which were designed on the assumption that the contamination rate would be less than 0.4%.

The preliminary contamination rate is far higher; 3% of the properly-collected samples were contaminated with high-concern microorganisms associated with disease, such as E. coli and Pseudomonas aeruginosa. Another 3% of samples were contaminated with low-concern organisms. Contamination with these organisms poses less of a threat to patients but still indicates healthcare facilities are failing to adequately clean a significant minority of duodenoscopes.

With the contamination rate coming in more than 1000% over the anticipated figure, FDA has shared the results and taken action. The manufacturers are performing root cause analyses to understand whether device damage, errors in reprocessing or other factors are behind the contamination rate. In addition, FDA is advising healthcare facilities to pay particular attention to the hard-to-clean elevator recess and adopt quality control programs for duodenoscope reprocessing.

Manufacturers provide user materials that should convey the reprocessing requirements but there are question marks over the effectiveness of the documents. To probe those doubts, FDA ordered the manufacturers to run a human factors study. FDA also has results from that study.

The human factors study found that the current user manuals are hard to read and follow. This is leading to problems such as the inadvertent skipping of cleaning steps and the need for additional training. Having identified the materials as a contributing factor to the problem, FDA is working with manufacturers to improve the documents.

FDA thinks improved documentation and greater vigilance are needed because of the complexity of duodenoscopes, which feature multiple small parts, and the effect this has on ease of cleaning. In the longer term, FDA wants to see manufacturers to tackle this root cause of the problems identified in the two post-market studies.

"It has become clear that following the manufacturer’s reprocessing and maintenance instructions, while critical, is not sufficient to avoid all infections associated with the use of duodenoscopes. That is why the FDA has also been working with developers on new product designs, including disposable components," Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement.

FDA expects to have final results from the sampling and culturing study next year.