The Food and Drug Administration recently issued a “safety communication” warning that a common medical device used to perform procedures that over 500,000 Americans undergo annually, may put patients at risk for developing “super bug” infections.   The FDA communication, Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication, was issued on February 19, 2015 and updated on February 23rd.  The communication includes a summary and scope of the problem, as well as recommendations for facilities and staff that reprocess ERCP duodenoscopes.  While the intended audience of the safety communication is health care providers (gastroenterologists, surgeons, nurses, health care facility staff) and patients, the alert underscores the importance of the design, warnings and instruction manuals for these devices.

Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat and stomach to diagnose and treat conditions in the small intestine.  They are widely used for common procedures.  But, the design of the duodenoscope makes it very difficult to clean.  According to the FDA, they “contain microscopic crevices” that are not easy to clean.  As a result, the FDA warns, “[r]esidual body fluids and organic debris may remain in these crevices.”  When used with another patient, these contaminants can cause infection.  The FDA reported that in the last two years, 135 patients developed infections that may be associated with contaminated duodenoscopes.   Many of these infections were with antibiotic-resistant “super bugs.” These “super bugs” are extremely dangerous, especially to patients with weakened immune systems.

“Residual body fluids and organic debris may remain in these crevices.”

According to the FDA communication, the agency is “closely monitoring the association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia coli.”  It is continually evaluating “information about documented and potential infections from multiple sources, including Medical Device Reports (MDRs) submitted to the FDA, the medical literature, the health care community, professional medical societies, and the Centers for Disease Control and Prevention (CDC).”  From January 2013 through December 2014, the FDA “received 75 MDRs encompassing approximately 135 patients in the United States relating to possible microbial transmission from reprocessed duodenoscopes.”

Questions about the FDA’s communication, can be directed to the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.