Deadly CRE Outbreak Raises Red Flags for GI

UCLA Medical CenterThe combination of antibiotic-resistant pathogens and a medical instrument known for being difficult to sanitize proved deadly for two patients at Ronald Reagan UCLA Medical Center in Los Angeles last week. The patients died from carbapenem-resistant Enterobacteriaceae (CRE) infections traced to contaminated duodenoscopes. So far seven patients have been confirmed with CRE infections and the hospital says a total of 179 were exposed from October 2014 through January 2015, with all exposures traced to two duodenoscopes that have since been removed from service. Hospital officials say the suspect scopes were being sanitized according to manufacturer’s directions, but the hospital has implemented even more stringent reprocessing procedures.

This is not the first time in memory that tainted duodenoscopes have caused a CRE outbreak. Hospitals in suburban Chicago and Pittsburg experienced scope-related CRE infections in recent years. From 2012 to 2014, Seattle-based Virginia Mason Medical Center had 35 patients acquire CRE infections. In response to that incident, Sen. Patty Murray from Washington earlier this month wrote to the Food and Drug Administration urging the agency to issue new standards and best practices for sanitizing duodenoscopes. She’s also asking the FDA to improve its tracking of problems caused by the devices.

Olympus-TJF-20-DuodenoscopePrincipally used to perform endoscopic retrograde cholangiopancreatography or ERCP, the complicated nature of the procedure itself makes duodenoscope design complex and intricate. The design requirements of extreme flexibility and precise functionality present inherent challenges to sanitizing and require that they be properly and thoroughly reprocessed to prevent the spread of bacteria and resulting infections. In this new day and age of quality-based care, with CMS challenging providers to lower hospital-acquired conditions, the urgency of proper endoscope reprocessing and sanitizing can’t be overstated.

The FDA responded to the UCLA Medical Center outbreak by issuing a safety warning last week, citing recent reports associating multidrug-resistant bacterial infections in patients undergoing ERCP with reprocessed side-viewing duodenoscopes. The FDA updated the safety communication on Monday. While the agency is calling attention to the problem of potential CRE infections and offering some new guidance, it doesn’t appear to be considering more drastic action like removing all side-viewing duodenoscopes from service, stated that “the lifesaving nature of ERCP…makes it important for these devices to remain available.”

Preventing the spread of CRE infections is a mission-critical imperative for healthcare providers due to the deadly nature of the bacteria involved. According to the Centers for Disease Control, CRE bacteria can be lethal for up to half of patients infected. Because they’re resistant to most and sometimes all antibiotics, CRE infections are especially difficult if not impossible to treat effectively. Likewise, duodenoscopes are especially difficult to clean and sanitize. A 2013 study from the infection prevention division of 3M showed duodenoscopes were ten times more likely to fail the study’s criteria for manual cleaning than colonoscopes.

Considering every year about half a million ERCP procedures are performed in the US, the actual incidence of CRE infection per procedure nationwide remains low. But because of the high mortality rates and resistance to antibiotics associated with CRE infections, it remains a risk that must be appropriately managed and mitigated to maximize patient safety.


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