Infection Using ERCP Endoscopes

Abstract

© 2016 by the AGA Institute 0016-5085/$36.00 http://dx.doi.org/10.1053/j.gastro.2016.05.040 Ttion during endoscopic retrograde cholangiopancreatography (ERCP) continues to evolve. The occurrence of carbapenem-resistant Enterobacteriaceae infections after ERCP reached the awareness of the medical community in 2014 when the Centers for Disease Control and Prevention (CDC) published the findings of their investigation of a suburban Chicago case cluster. In early 2015, reports of similar outbreaks at several major medical centers across the United States prompted the US Food and Drug Administration (FDA) to issue safety alerts and convene an FDA expert panel; there was intense media attention and both the CDC and industry provided guidance regarding steps for ensuring safe clinical care in the absence of definitive solutions. In 2016, the release of a US Senate committee investigative report culminated in a closely coordinated FDA and industry recall of duodenoscopes for refurbishment and replacement of suspect parts, among other related actions. Despite progress in our awareness and understanding of the problem, the currently proposed solutions remain cumbersome and unproven. Endoscope cleaning and reprocessing technologies and practices progressed greatly in the latter part of the 20th century, culminating in enduring standards for high-level disinfection (HLD). In the Spaulding classification for reprocessing of durable medical devices, endoscopes are designated as “semicritical” devices that make contact with mucous membranes and thus are suitable for HLD. Transmission of infection by flexible endoscopes has historically been ascribed to inconsistent practice of manual cleaning and HLD. Outbreaks of Pseudomonas aeruginosa after ERCP using side-viewing duodenoscopes dating to the 1980s were noted to occur particularly in the first patient of the day after overnight storage and shortly after reprocessing. This problem was largely eliminated with adoption of complete channel drying by alcohol flushing and forced air perfusion after HLD. Clinical infections occasionally follow the use of ERCP in patients with preexisting chronic colonization of bacteria (owing to obstructing pathology, abnormal anatomy, indwelling prostheses, or prior interventions). The recent occurrences of interpatient transmission via the duodenoscope only became evident when infections with newly recognized, highly resistant species prompted point source investigations using sophisticated bacterial typing to determine their origin. A recent single-center study using universal culturing of reprocessed endoscopes demonstrated that 2% of patient-ready instruments harbored persistent enteric pathogens. Thus, we now realize that contaminated endoscopes can transmit some antibioticsensitive, as well as highly resistant cases, of post-ERCP cholangitis. Furthermore, the unusual resistant cases can result in chronic colonization of the gastrointestinal tract, with delayed infectious complications weeks to months later in unrelated organ systems. Infectious cross-contamination also occurs from other hospital or institutional sources, as demonstrated in outbreaks of carbapenem-resistant Enterobacteriaceae in intensive care units and chronic nursing facilities. The frequency of transmission through the environment, however, is generally far lower than for iatrogenic exposure and investigations strongly suggest that the endoscope is the transmission source in most outbreaks of post-ERCP multidrug-resistant infections. The recent report of the Senate’s Health, Education, Labor, and Pensions Committee thoroughly outlines the breadth of the problem and potential regulatory and industry factors contributing to the delay in response to the risk of duodenoscope transmission of infection (Table 1).