FDA Safety Communication Follows Superbugs Emerging from Dirty Endoscopes

February 20, 2015

On February 19, 2015, the FDA issued a safety communication regarding medical devices used to perform endoscopies because their design “may impede effective cleaning.” That is, the design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes, which can be “re-used, and cleaned” several times each day” according to NBC News, allows contamination such that patients can be infected with “superbugs”—drug-resistant bacteria. The ERCP duodenoscopes have been linked to “superbug” infections most recently at the Ronald Reagan/UCLA Medical Center in Los Angeles.

bacteriaCarbapenem-resistant Enterobacteriaceae (CRE) is the name for “superbugs,” which cannot be treated with antibiotics. CRE include bacteria that live in the colon, such as Klebsiella species and E. coli, which have obtain way to become multi-drug resistant, according to UCLA and the FDA. The Los Angeles County Department of Public Health and UCLA, for example, found that “routine cleaning of the ERCP scopes as recommended by the scope manufacturer does not completely eradicate CRE as it does for other bacteria and viruses.”

Patient Deaths Connected to Endoscopes

A statement from UCLA explained that 179 patients who underwent a procedure with an ERCP endoscope between October 3, 2014 and January 28, 2015, were notified they may be at risk of exposure to CRE. During this period, seven patients were injured, two of whom died, due to the exposure to the CRE “superbug,” according to USA Today. USA Today further reported that in a 2012 Seattle, Washington, outbreak of CRE connected to the duodenoscopes, revealed 32 patient diagnoses and seven deaths within 30 days. The UK’s Daily Mail reported on dirty endoscopes leading to 44 infected patients in Illinois earlier this year. The Associated Press reports that an 18-year-old who had a procedure at UCLA Medical Center in October 2014 involving a contaminated endoscope is fighting to survive.

ERCP Duodenoscopes Involved in 500,000 Procedures Yearly in United States

duodenoscopeThe FDA’s Safety Communication targets all ERCP endoscopes, which are “side-viewing duodenoscopes” used in “[m]ore than 500,000 ERCP procedures each year in the U.S. These devices are “flexible, lighted tubes that are threaded through the mouth, throat, stomach, and into the top of the small intestine (duodenum).” As the FDA discusses, the design of these endoscopes is complex, which “improves the efficiency and effectiveness of ERCP” but “causes challenges for cleaning and high-level disinfection.” In fact, “part of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible.” The duodenoscopes are manufactured by companies primarily involved in camera design, including FUJIFILM, Olympus Corp. of the Americas., and Pentax, according to news outlets and the FDA. The FDA is monitoring the connection between CRE and the duodenoscopes while working with manufacturers to develop better disinfection procedures.

Injured by an ERCP Endoscope?

If you or a loved one have been injured by an ERCP endoscope, call 1-800-254-9493 or fill out the form to the top right for a free consultation with our personal injury attorneys.