The last time we mentioned duodenoscopes and the risk of infection that comes with their use, the United States had a different president. Britain was still firmly in place as a part of the European Union and the first #metoo post hadn’t yet been posted to social media.
It was 2015, and in response to a number of infections and multiple deaths stemming from infections contracted from the use of unclean and contaminated duodenoscopes, the FDA was taking measures to force manufacturers of the devices to study the problem and develop a solution. Those manufacturers; namely Fujifilm Medical Systems USA Inc., Olympus Medical Systems Corporation, and Pentax of America, were told to monitor the situation and surveil the market themselves and report back to the agency.
The results of those studies are in, and they’re worse than expected.
CNN reports that earlier this month the FDA stated that “the preliminary results as of March 2019 indicate higher than expected levels of contamination. Our analysis of medical device reports associated with patient infections for duodenoscope indicates that the number of medical device reports peaked in 2015 at 250 reports and declined 62% to fewer than 100 reports per year in 2017.”
2018, however, would not be so kind. 205 reports submitted that year alone yielded 45 patient infections and 159 reports of contaminated devices. Three deaths were also reported during that time.
Putting all of this another way, people are still dying of infections contracted from contaminated and unclean duodenoscopes more than three years after the problem first started gaining traction in the medical community. And, after dropping to less than 100 in one year, the number more than doubled the following year.
Duodenoscopes were designed to be a minimally-invasive way for doctors to peer into the human body and view the pancreas, bile duct, and other abdominal organs without the need for exploratory surgery. Their design, however, makes them very difficult to clean. Even after revised instructions were released by their manufacturers pertaining to cleaning and reprocessing of the scopes between uses, subsequent inspections of the devices continued to find contamination by a superbug known as CRE, or carbapenem-resistant Enterobacteriaceae.
Duodenoscopes are used in over 500,000 procedures every year. The FDA is currently pushing manufacturers to redesign the scopes or incorporate disposable materials into their construction in an effort to reduce ongoing infection numbers.