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 to decontaminate scopes proved to be inadequate.
The Los Angeles hospital's account on Thursday came hours after the Food and Drug Administration issued an advisory to health providers warning that the complex design of duodenoscopes—the endoscopes used in endoscopic retrograde cholangiopancreatography, or ERCP—might impede the ability to effectively “clean, disinfect and sterilize reusable devices." The FDA advised that strict adherence to manufacturers' instructions would minimize the risk of infection.
But according to Dr. Zachary Rubin, UCLA Medical's director of clinical epidemiology and infection prevention, his hospital's bacteria outbreak and several others involving duodenoscopes suggest the problem may lie with the recommendations from product makers.
UCLA officials said their investigation found no deficiencies in the facility's internal cleaning processes for the devices and that the staff fully adhered to the manufacturer's recommendations on properly sterilizing them.
“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.
Two people have died and as many as seven others have been infected from carbapenem-resistant enterobacteriaceae, or CRE, an infection resistant to most antibiotics after undergoing ERCP procedures at UCLA between Oct. 3 and Jan. 28, Rubin said.
After Jan. 28, the hospital began using more stringent sterilizing measures and has seen no subsequent cases of infection.
More than 500,000 ERCP procedures using duodenoscopes are performed in the U.S. each year as a minimally invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other conditions, according to the FDA. The agency said it received 75 medical-device reports between January 2013 and December 2014 regarding duodenoscopes and transmission of microbial pathogens to approximately 135 patients.
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