The latest outbreak of a deadly drug-resistant bacterial infection spread through contaminated endoscopes has prompted calls for re-evaluating the adequacy of currently recommended cleaning and reprocessing procedures. It's also led some observers to question why the Food and Drug Administration didn't act sooner despite previous outbreaks involving the scopes.
Leaders at Ronald Reagan UCLA Medical Center, where as many as 179 people were exposed to drug-resistant bacteria while undergoing endoscopic procedures, say the manufacturer-recommended protocols they followed were inadequate.
Between Oct. 3 and Jan. 28, two patients at the Los Angeles hospital died and as many as seven others were infected with carbapenem-resistant enterobacteriaceae, or CRE, an infection resistant to most antibiotics. They were exposed while undergoing endoscopic retrograde cholangiopancreatography procedures, said Dr. Zachary Rubin, UCLA Medical Center's director of clinical epidemiology and infection prevention.
His hospital's outbreak and several other recent outbreaks involving duodenoscopes suggest the problem may lie with the recommendations from the manufacturers, Rubin said. The ERCP procedures are a minimally invasive way to treat blockages in the pancreas and bile duct.
UCLA officials said their investigation found that staff fully adhered to the manufacturer's recommendations on properly sterilizing the devices. “The fact that we've identified this infection in a couple of different hospitals now suggests that the routine process we were using was just not quite adequate even though at the time they were FDA-approved,” Rubin said.
In response to the UCLA outbreak, the FDA issued an advisory last week that the complex designs of duodenoscopes “might impede the ability to effectively clean, disinfect and sterilize reusable devices.” The agency acknowledged that even strict adherence to manufacturers' disinfection instructions will not fully eliminate the risk.