Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum) and are used in endoscopic retrograde cholangiopancreatography procedures (ERCP).
ERCP is the least invasive way to drain fluids from the digestive system which may be blocked by tumors, gallstones or other health conditions, and is not to be confused with the endoscopes used for routine upper gastrointestinal endoscopy or colonoscopy.
Although these procedures are often for very common conditions, the resulting infections can be deadly.
More than 500,000 of these procedures are performed annually and Olympus America is the largest supplier in the U.S. of the TJF-Q180V duodenoscope, which is the subject of the recent bacterial ‘super bug’ outbreak, specifically CRE (carbapenem-resistant Enterobacteriaceae) infections which tend to be more resistant to treatment. Other manufacturers of these duodenoscopes include FujiFilm and Pentax.
On February 19, 2015, the FDA warned that the design of these duodenoscopes, which have many small parts, is more complex and therefore may be more difficult to clean and disinfect, contributing to the spread of disease.
From January 2013 until December 2014, the FDA received 75 adverse event reports involving approximately 135 patients who may have contracted an infection after use of the duodenoscope. The FDA has admitted that based on its review of the information it has received to date “Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.” The FDA is continuing to investigate the connection between the use of these scopes and the transmission of antibiotic-resistant microbes.
According to an article in the Los Angeles Times, the Ronald Reagan Medical Center at UCLA has been at the center of this ‘super bug’ outbreak and, at least 7 people have been infected by a bacteria linked to the duodenoscopes; 2 people have died and more than 179 others may be at risk.
Sterilization procedures have now been enhanced beyond those required by the manufacturer and in excess of the national standards, to include using a gas called ethylene oxide in a second sterilization.
An article from the NY Times claims that the FDA never previously reviewed data from manufacturers regarding the procedures for cleaning duodenoscopes and is only now asking manufacturers to provide evidence that the method they recommend for disinfecting the devices does in fact work.
As early as 2013, duodenoscopes have been associated with similar outbreaks like in a hospital in Illinois where 39 patients were also infected with CRE, the same bacteria responsible for the infections in Los Angeles. The CDC team which investigated that outbreak in Illinois, found at that time that the duodenoscopes used in those procedures remained contaminated even after the proper cleaning process.
According to the Wall Street Journal, the FDA now recommends that the cleaning process for gastrointestinal medical devices such as duodenoscopes, include mandatory sterilization with ethylene oxide before reuse. This process and the chemical it uses can be expensive and potentially toxic to workers.
Despite these findings and the current outbreak, the FDA has not recommended that hospitals stop using these medical scopes.