The Food and Drug Administration on Thursday warned doctors and hospitals that a commonly used type of medical scope can be difficult to sanitize between uses and “may facilitate the spread of deadly bacteria.”
The agency’s warning came a day after news broke that seven patients had been infected by a drug-resistant “superbug” at UCLA’s Ronald Reagan Medical Center since last fall. Two of the patients died, and public health authorities are tracking down nearly 200 others who might have been exposed to the dangerous bacteria through the use of the contaminated medical scopes.
Known as duodenoscopes, the devices are used in hundreds of thousands of procedures each year in the United States to drain fluids from pancreatic and bile ducts blocked by cancer tumors, gallstones and other conditions. Doctors consider them an important tool in detecting and treating medical problems early and in a minimally invasive way.
The California outbreak, first reported by the Los Angeles Times, represented the latest in a string of lethal superbug episodes linked to the specialized scopes.
Since 2012, similar outbreaks have occurred at Advocate Lutheran General Hospital near Chicago, where 44 people were infected, and at the Virginia Mason Medical Center in Seattle, where at least 32 patients became ill and 11 died. It’s unclear how significant a role the bacterial outbreak played in those deaths, but the Seattle hospital stressed that the instruments were cleaned according to the manufacturer’s stipulations.
Lawmakers and patient-safety experts have increasingly pressed the FDA and device manufacturers to issue warnings about the problem and take steps to fix it. The Centers for Disease Control and Prevention alerted the FDA to the potential problem in the fall of 2013. Over the past two years, the FDA has received at least 75 reports of incidents involving at least 135 patients. Sen. Patty Murray (D-Wash.) earlier this month wrote to FDA Commissioner Margaret Hamburg, urging the agency to publicly address the issue. Until Thursday, that had not happened.
“The FDA is not doing its job,” said Lawrence Muscarella, a hospital-safety consultant and expert on endoscopes who has been monitoring the problem in recent years. “It’s really not acceptable. . . . These reports have been coming for at least 3 to 5 years.”
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