Increasing numbers of infections and deaths reported from scope decontamination

After a leveling out of infections and deaths related to contaminated duodenoscopes, the problem appears to be resurfacing with three deaths, 45 infections and more than triple that number of contaminations detected on the devices. Finding are based on the results that The Food and Drug Administration received from post-market surveillance studies on duodenoscopes manufactured by Fujifilm Medical Systems USA, Inc, Olympus Medical Systems Corporation, and Pentax of America.

FDA ordered the companies to conduct the studies so the agency could better understand how duodenoscopes are reprocessed in real-world settings. After a sizeable drop in incidents in 2017, FDA said it assumed the most recent studies would yield less than a 0.4 percent contamination rate but, according to preliminary results, they saw much higher-than-expected levels of contamination.

The studies are mandated under Section 522 of the Federal Food, Drug, and Cosmetic Act (“522 studies”) for duodenoscopes used in Endoscopic Retrograde Cholangiopancreatography procedures (ERCP). Preliminary findings include:

• For low to moderate concern organisms with >100 CFU, updated culturing results show up to 3.6 percent of properly collected samples testing positive.
• For high concern organisms, defined as organisms that are more often associated with disease, such as E. coli, and Pseudomonas aeruginosa, updated culturing results appear to show that up to 5.4 percent of properly collected samples test positive – and increase from 3 percent previously reported.

FDA says root cause analyses are underway to determine why the culturing results are so high and is urging healthcare systems to strictly adhere to the manufacturer’s instructions for use (IFU), follow best practices, and report adverse events to the FDA. The numbers of samples collected, contamination results to date, and summary of the study plans, are available on the respective FDA 522 Postmarket Surveillance Studies webpage for each manufacturer.

“Let me be clear, the percent of contaminated samples based on these interim results shows that improvements are necessary, and we are committed to taking additional steps to reduce infections and contamination even further,” stated FDA’s Jeff Shuren, Director of the Center for Devices and Radiological Health in a news release. “We are considering whether additional recommendations will be necessary to help healthcare facilities with proper cleaning and high-level disinfection of duodenoscopes to lower contamination rates to less than 1 percent.

Last year FDA said it observed a decline in the number of medical device reports associated with patient infections after safety measures to improve reprocessing techniques were implemented, beginning in 2015. The agency’s analysis of medical device reports associated with patient infections from duodenoscopes indicates that report numbers peaked in 2015 at 250 reports and declined 62 percent to fewer than 100 in 2017.

Now  FDA says it has received additional medical device reports of patient infections and device contamination. FDA analysis of the 205 medical device reports received from October 15, 2018 through March 31, 2019 includes 45 reports of patient infection, one report of patient exposure, and 159 reports of device contamination. In 2018, three deaths were reported in the U.S. related to duodenoscopes.

“We are exploring whether supplemental measures, such as sterilization, in addition to meticulous cleaning, might offer a more effective option,” Shuren said  “This will take careful consideration because we know some sterilization methods could damage the duodenoscope over time and lead to a shorter lifespan for the expensive device.”

FDA issued Warning Letters in March to all three manufacturers for failure to provide enough data to address requirements under Section 522. The companies responded with plans that outline how study milestones will be achieved including enrolling new sites and collecting samples. Visit FDA’s recommendations for reprocessing duodenoscopes, which the agency says have not changed.