The FDA issued a “safety communication” aimed at gastroenterologists, surgeons, health-care staff and patients warning that the design of duodenoscopes may impede effective cleaning.
Amid new reports of deadly superbug outbreaks tied to contaminated medical scopes, Food and Drug Administration officials on Thursday warned health workers, hospitals and patients that the specialized devices may transmit infections, even when cleaned as directed.
The move comes a day after the instruments were blamed for infecting seven patients at a Los Angeles hospital, including two who died, and weeks after reports of an outbreak of drug-resistant bacteria at Seattle’s Virginia Mason Medical Center that involved at least 32 patients, including 11 who died. It’s not clear whether the superbug infections were to blame for those deaths.
The FDA issued a “safety communication” aimed at gastroenterologists, surgeons, health-care staff and patients warning that the design of duodenoscopes used in procedures known as endoscopic retrograde cholangiopancreatography, or ERCP, may impede effective cleaning.
“Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it,” the warning said.
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More than 500,000 ERCP procedures using the scopes are performed in the U.S. each year, typically to treat problems with pancreatic and bile ducts.
The instruments were blamed for seven infections at Ronald Reagan UCLA Medical Center, including in two people who died, the Los Angeles Times reported Wednesday. The patients were infected with CRE, or carbapenem-resistant enterobacteriaceae, during the procedures. Nearly 180 patients were notified that they may have been exposed to the antibiotic-resistant bacteria, which have a mortality rate of as high as 50 percent, according to the Centers for Disease Control and Prevention.
At Virginia Mason, the infections included some carbapenem-resistant bacteria, but also drug-resistant bacteria known as HyperAmpC. Officials at the Seattle hospital, along with those from Public Health — Seattle & King County, declined to notify patients and families involved in the local outbreak. Officials said there was little that the very sick people could have done in response to this information.
Virginia Mason officials say they’ve overhauled their cleaning protocol for the devices.
News of the rare, multidrug-resistant infections at Virginia Mason was released this fall, more than two years after the first infections were detected, in a small abstract published at a conference of the Infectious Diseases Society of America.
FDA officials said they were “closely monitoring” the potential link between the scopes and the transmission of infections, Thursday’s warning noted.