Recent media reports have raised concerns about the use of the Olympus TJF-Q180V Duodenoscopes during Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures. The use of this particular duodenosope was linked to seven patients being infected at Ronald Reagan UCLA Medical Center with the superbug CRE — also known as carbapenem-resistant Enterobacteriaceae. Even though ERCP procedures are not performed at McAfee Army Health Clinic, more than 500,000 ERCP procedures using duodenoscopes are performed in the United States annually. It should be noted that this scope is prevalent in operating rooms, emergency rooms, GI clinic/suites, and in civilian practice, including our TriCare network providers, who are continuing to use the TJF-Q180V scope in accordance with U.S Food and Drug Administration (FDA) guidance.
Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, this same complexity causes challenges for cleaning and high-level disinfection. The FDA is closely monitoring the association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections. The FDA is not recommending healthcare providers cancel procedures for their patients who need them, nor have they advocated for removal of the device from the market because it could lead to an insufficient number of available duodenoscopes to meet the clinical demand.
If you recently had a procedure that involved the use of a duodenoscope and you have concerns, please contact your primary care doctor. For more information please go to: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm