FDA warns of device design amid UCLA superbug outbreak

Olympus TJF-Q180V Duodenoscope--Courtesy of Olympus Australia

Amid a drug-resistant "superbug" outbreak at the UCLA Health System in California, the FDA is warning doctors and hospitals that an endoscope device's complex design may hinder proper cleaning, contributing to the spread of deadly bacteria.

The agency's warning applies to duodenoscopes, or flexible tubes that are threaded through the mouth, throat, stomach or the top of the small intestine to drain fluids from blocked pancreatic or biliary ducts. The devices are used in more than half a million procedures each year in the U.S. and are the "least invasive way" to drain fluids, the FDA said its warning.

But duodenoscopes' design makes the devices hard to sterilize, which could lead to broad transmission of infectious bacteria. Even though cleaning and disinfecting the products should reduce the risk of transmitting infection, it "may not entirely eliminate it," the FDA noted in its warning. The agency also pointed to a "growing body of literature" and a recent internal assessment that found design issues in duodenoscopes, complicating the cleaning process for the devices.

The FDA warning comes a month after UCLA's Ronald Reagan Medical Center first reported deadly infections while conducting tests on a patient. An internal investigation showed that two medical duodenoscopes may have transmitted the infection between October and January at the hospital, even though the scopes were sterilized to manufacturer's standards, the Washington Post reports.

Since then, seven patients were infected with a potentially deadly, drug-resistant strain of bacteria and Los Angeles public health authorities are tracking down at least 179 other patients who might have been exposed through contaminated scopes, according to the Washington Post article.

Companies such as Olympus, Fujifilm Holdings and Pentax Medical make the devices, and Olympus, UCLA's endoscope supplier, told the Los Angeles Times that it is working with the FDA and healthcare systems to address the public's concerns.

Meanwhile, the agency has been "actively engaged" with other government agencies, including the CDC, and duodenoscope manufacturers in the U.S. to get to the root of the problem and find solutions to minimize patient exposure, the FDA said in its warning.

Still, some patient safety advocates say the industry and regulators have not responded quickly enough to the outbreak. Lawrence Muscarella, a Pennsylvania-based hospital safety consultant and expert on endoscopes, called the number of cases at UCLA and other hospitals "unprecedented."

"Hospitals and manufacturers often take months to assess what to do, with the infected patients being the last to know," Muscarella told the Los Angeles Times. "Bringing patients into the loop and answering their questions is important for hospitals to prevent outbreaks."

- read the FDA warning
- here's the Washington Post story
- get more from the Los Angeles Times