FDA Issues Important Safety Communication:
Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning
In previous emails, we have made members aware of reported cases of multi-drug resistant organisms (MDRO) being transmitted via ERCP. Transmission is thought to have occurred in the absence of a reprocessing protocol breach or evidence of defects in the duodenoscope. At this time, it is thought that cleaning the elevator and elevator channel of the duodenoscope are presenting challenges for reprocessing.
MDRO are bacteria that cannot be eradicated with many common antibiotics due to resistance. MDRO include carbapenem-resistant Enterobacteriacae (CRE) such as Escherichia coli or Klebsiella pneumoniae harboring one of several classes of carbapenemases resistance factors, which include the Klebsiella Pneumonia Carbapenemase (KPC) and the emerging New Delhi mettalo-b-lactamase (NDM-1). While it may be difficult to link an infection with CRE to a particular procedure such as an ERCP, these infections are a significant public health concern as the mortality from these kinds of infection is high and treatment options are limited.
Today, the FDA issued a safety communication on this matter to raise awareness among health care professionals that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing. According to the FDA statement, “Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.”
The FDA monitors Medical Device Reports (MDRs) for health-risk issues related to these devices. According to the FDA, “In total, 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. It is possible that not all cases have been reported to the FDA. The agency is continuing to evaluate 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).”
As you are aware, ERCP is an important and often life-saving procedure for patients in need. It is estimated that some 500,000 ERCPs are performed annually. While this infection risk is concerning, for many patients in need of ERCP, the benefits of ERCP outweigh the risk of infection when reprocessing guidelines are followed.
Read the complete FDA safety communication. We urge you to forward and share the FDA safety communication with providers and staff involved in reprocessing at your institution. In addition, below are suggestions of actions you can take at this time.
ASGE Recommendations Based on What is Known at this Time
ASGE Convenes Duodenoscope Infection Control Summit