The Food and Drug Administration has issued a general warning to health providers regarding the use of medical endoscopes for complex endoscopic procedures such as the one that led to seven people becoming infected with a superbug bacteria at a Los Angeles hospital. Two of those patients died.
The complex design of endoscopes used in endoscopic retrograde cholangiopancreatography, also known as duodenoscopes, might impede the ability to effectively “clean, disinfect and sterilize reusable devices,” stated the warning, posted on the agency's website Thursday.
“Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection,” the warning stated. “Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible.”
More than 500,000 ERCP procedures using duodenoscopes are performed in the United States annually, according to the FDA, as a minimally invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions.
The agency said it has received 75 medical device reports between Jan. 2103 and Dec. 2014 regarding duodenoscopes and possible transmission of microbial pathogens to approximately 135 patients.
Despite acknowledging the difficulty in cleaning the devices, the agency recommended health facilities adhere to manufacturer instructions as a means of minimizing the risk of infection.
The warning comes as health officials in California are trying to trace as many as 179 patients who may have been exposed to Carbapenem-Resistant Enterobacteriaceae, an infection resistant to most antibiotics after undergoing ECRP procedures at Ronald Reagan Medical Center at the University of California at Los Angeles between October 2014 and January 2015.
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