FDA Issues Safety Warning on Endoscopes as News of Superbug Threat Hits UCLA Hospital

The Food and Drug Administration (FDA) has issued recommendations for healthcare professionals regarding endoscopic retrograde cholangiopancreatography (ERCP) endoscopes (duodenoscopes) in response to adverse event reports of multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly.

While the design of duodenoscopes can improve the efficiency and effectiveness of ERCP, it may also create challenges in cleaning and high-level disinfection; some parts of the duodenoscopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be feasible. Residual body fluids and organic debris may remain in these crevices following cleaning and disinfection, which may expose patients to serious infections if the fluids contain microbial contamination.

From January 2013 to December 2014, the FDA received 75 Medical Device Reports encompassing approximately 135 patients in the United States regarding possible microbial transmission from reprocessed duodenoscopes. In October 2014 an Illinois hospital reported an outbreak of Escherichia coli outbreak from endoscopes that had bacterial contamination despite being disinfected in the recommended way. At least 35 patients became ill and 11 died after becoming infected with carbapenem-resistant Enterobacteriaceae (CRE) as a result of contact with contaminated endoscopes at a hospital in Seattle, WA in January, despite cleaning of the devices that was performed in accordance with the manufacturer’s instructions. The UCLA Health System has recently notified over 100 patients that they may have been infected by the same drug-resistant bacteria during complex endoscopic procedures that took place between October 2014 and January 2015. Infection in seven patients has been confirmed and may have been a contributing factor in two patient deaths. Both healthcare organizations are now utilizing a decontamination process that exceeds beyond manufacturer and national standards.

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