Deadly drug-resistant bacteria can be difficult or even impossible to remove from the tiny crevices of a reusable medical scope doctors use to remove gallstones and detect cancer in half a million Americans a year, the Food and Drug Administration warned Thursday.
The FDA alert on contaminated duodenoscopes comes after news reports that two patients in California died after contracting forms of a drug-resistant form of bacteria known as Carbapenem-resistant enterobacteriaceae, or CRE. The FDA said at least 135 people have probably gotten the bacteria from scopes nationwide, but health officials in Los Angeles County said the outbreak has affected more than 180 patients there.
CRE, which is sometimes called a "superbug" because it is resistant to multiple antibiotics, has been a public health concern in Minnesota as well. More than 370 cases have been reported in the state since 2011, though state Health Department officials on Thursday said none is related to duodenoscopes.
Doctors on Thursday said the FDA alert is a pointed reminder of the need to be vigilant to prevent and detect transmission of CRE, but that the public must be assured that the risk of getting sick from the bacteria remains less significant than the harm that could come if gallstone and cancer patients forgo necessary procedures.
"We're taking this very seriously," said Dr. Martin Freeman, chief of gastroenterology and hepatology at the University of Minnesota Medical Center, which does about 1,200 such procedures a year. "I don't think the public should be alarmed to the point of being afraid to have one of these. The appropriate steps are being taken, and I think it's getting the attention it deserves."
The United States has seen half a dozen confirmed CRE outbreaks related to endoscopes in recent years, including in Seattle and Chicago. But Thursday's FDA alert came one day after the Los Angeles Times reported two patients died at UCLA's Ronald Reagan Medical Center after contracting the bacteria following scoping procedures there.
The duodenoscope is a complex type of reusable endoscope that is fed down the esophagus and into the bile duct, where it can be used to drain fluids and remove gallstones that have migrated out of the gallbladder. The device can be used with other tools to snip samples for cancer testing or even place small stents to hold a gallbladder open.
The FDA warned duodenoscopes may harbor infectious bacteria even after cleaning because of the difficult design, which includes a long hollow tube through which to run a surgical tool and a moving part on the end of the scope called an elevator. Residual bodily fluids and organic debris may collect in the tiny crevices in the device and potentially transmit bacteria, including CRE bugs that are immune to multiple forms of antibiotics.
