FDA Issues Warning About Endoscopes in Wake of ‘Superbug’ Infection

The U.S. Food and Drug Administration (FDA) is warning doctors and hospitals nationwide that a commonly used medical scope could be difficult to clean and  “may facilitate the spread of deadly bacteria.”

The agency’s Feb. 19 warning was triggered by an outbreak of a drug-resistant “superbug” at University of California-Los Angeles Ronald Reagan Medical Center that infected  seven patients and killed two others. Public health authorities are tracking down at least 179 other patients who might have been exposed to the dangerous bacteria through the use of contaminated medical scopes.

The affected patients suffered from a drug-resistant superbug known as CRE, or Carbapenem-Resistant Enterobacteriaceae, during “complex endoscopic procedures” to diagnose and treat diseases in the pancreas between October and January at the hospital, UCLA’s Health System said in an emailed statement.

In its warning, the FDA said the medical scopes in question — duodenoscopes — are used in more than 500,000 procedures annually in the United States as the “least invasive way” of draining fluids from pancreatic and biliary ducts blocked by tumors, gallstones and other conditions. The light, flexible tubes are typically threaded through the mouth, throat, stomach, or into the top of the small intestine. Unlike other endoscopes, they have a movable “elevator” mechanism at one end that allows the instrument to treat problems with fluid drainage.

But that intricate design also can make the devices difficult to sterilize, the FDA said. “Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible,” the FDA said in a notice to medical professionals. One mechanism at the tip has microscopic crevices that a brush cannot access. “Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection,” the FDA noted.

Cleaning the scopes is “a detailed, multi-step process,” and meticulously following the manufacturer’s directions for disinfecting them “should reduce the risk of transmitting infection, but may not entirely eliminate it,” the agency continued.

UCLA told the Los Angeles Times, which first reported the deadly infections, that it detected the bacteria in January while conducting tests on a patient and alerted both the California and Los Angeles County health departments. An internal investigation revealed that two medical endoscopes may have transmitted the infection, though the scopes had been sterilized in line with the manufacturer’s standards, it said.

The CRE superbug has been described as a form of “nightmare bacteria” by Tom Frieden, head of the Centers for Disease Control and Prevention (CDC). “Our strongest antibiotics don’t work and patients are left with potentially untreatable infections,” he said. CRE infections, most of which occur in hospital settings, can lead to infections in the bladder or lungs, causing coughing, fever or chills. And according to the CDC, the bacteria kills nearly half of patients who get infections in the bloodstream.

The patients infected at the Ronald Reagan Medical Center had undergone a procedure called an ERCP, or endoscopic retrograde cholangiopancreatography, the Los Angeles Times reported. The test uses an endoscope and X-ray images to examine the pancreatic system to help diagnose tumors or treat gallstones, for instance. It is not the same one used for more common endoscopies and colonoscopies, the newspaper said.

Over the past couple years, similar outbreaks have occurred when contaminated scopes were used at Advocate Lutheran General Hospital near Chicago, Ill., where 44 people were infected, and at the Virginia Mason Medical Center in Seattle, Wash., where at least 32 patients became ill and 11 died, the Washington Post reported. Although it was unclear whether the outbreak in Seattle contributed to the deaths, the hospital stressed that medical professionals there, too, had cleaned the instruments according to the manufacturer’s stipulations.

Olympus Medical Systems Group, which is UCLA’s endoscope supplier, told the Los Angeles Times it is working with the FDA as well as doctors and hospitals to address public health concerns.

Patients who may have been exposed at Ronald Reagan Medical Center have been given a home-testing kit that medical professionals will analyze. The university is now taking steps to ensure patients’ safety.

“The two scopes involved with the infection were immediately removed and UCLA is now utilizing a decontamination process that goes above and beyond the manufacturer and national standards,” UCLA said in the statement.