Dive Brief:
- The FDA released a warning Thursday about the risks associated with ERCP endoscopes (side-viewing duodenoscopes) which have been linked to another superbug outbreak, this time at Ronald Reagan UCLA Medical Center.
- The FDA announcement followed the hospital's statement that seven patients had been infected with CRE related to contaminated duodenescopes, and that two of those patients had died. The hospital said up to 179 patients underwent procedures that utilized those scopes and were potentially exposed during a period from January 2013 to January 2014.
- The FDA warns that even with meticulous cleaning, duodenoscopes may still pose a risk. The agency says it is investigating possible solutions such as new disinfection protocols, as CRE is fatal in approximately 50% of cases and is resistant to most antibiotics.
Dive Insight:
This CRE outbreak is the latest of several across the US that have been tied to duodenoscopes, including one at a Seattle hospital that caused 35 patients to fall ill and 11 to die over a muti-year period. In January, a few experts registered concern about the design of the particular endoscope in question, which has "elevator wire channels" at the end of the scope. These small flaps, which hold stents and other components, are difficult to clean and might provide a haven for bacteria. The CDC said the design "makes them difficult to clean with the potential for contamination persisting following reprocessing and subsequent transmission of pathogenic bacteria to patients."
The CDC touched base with the FDA at the time, but the agency issued no recall or warning, despite encouragement from Virginia Mason Medical Center to do so. An FDA spokesperson told the Seattle Times that such action was unlikely as the agency then believed the device had a low infection rate and is a critical tool in a lifesaving procedure performed on as many as 500,000 patients per year.
This latest outbreak seems to have changed the agency's tune:
"Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it," the FDA announced. The agency says it is engaged with other agencies, including the CDC, as well as duodenoscope manufacturers "to identify the causes and risk factors for transmission of infectious agents and develop solutions to minimize patient exposure."