FDA issues warning on endoscopes linked to superbug outbreaks

Cleaning 'may not entirely eliminate' the risk of infection, agency says

FDA last week issued a general warning to hospitals over the design of duodenoscopes, noting that they are difficult to clean and can "facilitate the spread of deadly bacteria."

The warning came as Ronald Reagan UCLA Medical Center began notifying 179 patients who had undergone endoscopic retrograde cholangiopancreatography (ERCP), letting them know that the endoscopes used in their procedure may have been contaminated with Carbapenem-resistant Enterobacteriaceae (CRE). CRE has been called a "nightmare bacteria" by CDC Director Tom Frieden because it does not respond to most antibiotics and—if it spreads to the bloodstream—kills nearly half of its victims.

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UCLA says seven patients have tested positive for the bacteria so far and two have died, although hospital officials say that other factors besides CRE infection may have contributed to those deaths.

Other hospitals—including one in Seattle earlier this year—have also report CRE infections linked to contaminated endoscopes.

Overall, FDA says it has received 75 reports of infections linked to ERCP between Jan. 2013 and Dec. 2014, and says more cases may have gone unreported. However, this is the first time that FDA has issued a formal warning to doctors.

"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 agency says, adding, "Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection."

Duodenoscopes are different from other endoscopes used in procedures like colonoscopies. They are used on about 500,000 patients annually to treat cancers, gallstones, and other digestive-related illnesses.

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FDA says it is working with manufactures to better understand what causes the infections and "develop solutions to minimize patient exposure." In the interim, FDA is advising providers to follow the manufacturers' cleaning instructions. "Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it," the agency says.

Experts say that the advisory does not mean doctors should stop using duodenscopes. "Some of these patients (needing ERCP) are very sick and to take them into a surgical procedure could be risky," says Colleen Schmitt, president of the American Society for Gastrointestinal Endoscopy.

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The FDA says, "For most patients, the benefits of ERCP outweigh the risks of infection. ERCP often treats life-threatening conditions that can lead to serious health consequences if not addressed" (Eisler/Stanglin, USA Today, 2/19; Bever/Dennis, Washington Post, 2/19; Fox, NBC News, 2/19; Johnson, Modern Healthcare, 2/19 [subscription required]).

The takeaway: FDA has issued a formal warning noting that certain endoscopes have been linked to infection outbreaks and may be hard to clean adequately because of their complex design. However, FDA and other medical experts warn that the advisory does not mean doctors should stop using the devices.


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