Cedars-Sinai Medical Center has determined that four of its patients were infected with drug-resistant bacteria after undergoing a procedure, known as ERCP. The same device – a duodenoscope – was used in all four patients, between August 2014 and January 2015.
One of the four patients died from their underlying disease, and not the infection of Carbapenem-resistant Enterobacteriaceae, or CRE for short, according to Cedars-Sinai. The hospital says the patient's infection had already cleared.
Cedars says it began investigating whether any of its patients had CRE from a duodenoscope procedure, upon learning that seven people were infected with the so-called "superbug" after undergoing the same type of procedure with the same type of scope at Ronald Reagan UCLA Medical Center.
In a statement, Cedars says it meticulously followed the manufacturer's recommended disinfection procedures.
But the effectiveness of those recommended procedures has been questioned: The U.S. Food and Drug Administration warned Feb. 19 that, "meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it."
And last week, two UCLA patients filed lawsuits against the scope's manufacturer, Olympus Corp. of the Americas, for failing to fulfill its responsibility to provide a proven cleaning method for the device.
Cedars says there's no evidence that any other patients contracted CRE from a duodeonscope at the hospital. But, out of an "abundance of caution," the hospital says it's notifying 71 patients who had duodenoscope procedures since August 2014. It's offering them free home testing kits for CRE, which they can send to Cedars for analysis.
Cedars doctors have stopped using the specific scope that was linked to the infections. It also halted conducting elective duodenoscope procedures after it first learned of the outbreak at UCLA, but the hospital resumed the procedure today after taking several steps to protect patient health, it says.
Those steps include using enhanced disinfection procedures "above and beyond the manufacturer's recommendations," and instituting additional monitoring techniques, such as "a waiting period for duodenoscopes after disinfection, to allow for an additional bacterial analysis of the duodenoscope before use."
The FDA points out that there are more than 500,000 procedures performed with this type of duodenoscope each year, and that the risk of infection is extremely low.
This post has been updated.