ACTION STEPS Efforts to prevent duodenoscope-related infections have ramped up in recent months.The deadly outbreak at the UCLA Medical Center in Los Angeles that was linked to difficult-to-clean duodenoscopes certainly got people's attention, but trouble had been colonizing in reprocessing rooms across the country for years.
In the UCLA case, 2 patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) contracted carbapenem-resistant Enterobacteriaceae (CRE) from dirty scopes and died. Outbreaks related to the use of dirty duodenoscopes occurred in 2012 at the University of Pittsburgh Medical Center and in 2013 at Advocate Lutheran General Hospital in Park Ridge, Ill. Earlier this year, Virginia Mason Medical Center in Seattle, Wash., reported that 11 of 32 infected patients subsequently died. New reports suggest duodenoscopes were linked to the infections of 281 patients with a strand of E. coli at Hartford Hospital in Connecticut late last year.
The FDA says it received 75 Medical Device Reports between January 2013 and December 2014, involving approximately 135 patients, but it seems that concrete steps to address problems related to dirty scopes began in earnest this year. In late March, Olympus issued new reprocessing instructions for its TJF-Q180V duodenoscope. That's also when the American Society for Gastrointestinal Endoscopy (ASGE) gathered 60 experts for a duodenoscope infection control summit and the American Gastroenterological Association (AGA) convened a "Getting to Zero" meeting to figure out how to stop device-associated infections. Instruments manufactured by Fujifilm, Olympus and Pentax have been linked to the outbreak; the 3 companies said earlier this year that they will cooperate fully with the FDA to address concerns surrounding duodenoscopes and CRE infection.
Why didn't anyone act sooner? The answer, whether you choose to accept it or not, lies in striking a delicate balance between the undeniable benefit of using the scopes and the true risk of infection.
'A tough spot'
Patients who undergo ERCP are very sick, points out Stuart Gordon, MD, director of gastrointestinal endoscopy at Dartmouth-Hitchcock Medical Center in Lebanon, N.H. Duodenoscopes let physicians access the bile duct with minimal invasiveness during what are often outpatient procedures, says Dr. Gordon, who adds that major surgery is the only other option for treating complicated obstructions in the bile duct that duodenoscopes can remove.
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