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FDA Was Warned Almost Six Years Ago about Duodenoscope Infection Risks

May 22, 2015

Nearly six years ago, state and federal health officials privately urged the Food and Drug Administration (FDA) to alert hospitals about infection risks from specialized medical scopes that have been tied to a series of deadly superbug outbreaks.

The 2009 appeal came after duodenoscopes were linked to drug-resistant infections in numerous Florida hospital patients, including 15 who died, USA Today reports. Epidemiologists at the Florida Department of Health and the Centers for Disease Control and Prevention (CDC) warned that the infections occurred because hospitals were having trouble properly cleaning the scopes.

"This is likely not an issue limited to FL hospitals and it's quite concerning," Arjun Srinivasan, a CDC infection control expert, warned in an email sent to six FDA officials on April 22, 2009. Srinivasan urged an "educational alert" issued jointly by the CDC and the FDA. Seven months later, duodenoscopes were mentioned briefly in the 57th paragraph of a general advisory on proper cleaning and disinfection of all medical scopes, Duodenoscopes are used about 650,000 times a year for procedures in the bile and pancreatic ducts, USA Today reports.

It was not until winter 2015 that the FDA issued a specific warning about contamination risks that can persist even after a duodenoscope has been meticulously cleaned. By then, duodenoscopes had been linked to superbug cases in Chicago, Seattle, Los Angeles, Pittsburgh, Hartford and elsewhere, according to USA Today. Scores of patients were sickened, most with carbapenem-resistant Enterobacteriaceae (CRE), a drug-resistant bacteria, with mortality rates of 40 percent or more. At least 15 of those patients died. Roger Sanderson, a Florida epidemiologist who pushed for a federal alert on duodenoscope safety in 2009, says the cleaning challenges with duodenoscopes are unique and especially risky.

FDA officials insist the reference in the 2009 advisory was adequate based on what was known at the time. It was not until September 2013 that there was sufficient evidence of the risk to consider a more detailed warning. But, USA Today reports, it took 17 more months to evaluate what sort of advisory was needed. U.S. Rep. Ted Lieu has requested congressional hearings on the matter. Lieu says the FDA "should have begun issuing safety alerts and had the manufacturers look at (developing) new designs."

At the time Sanderson investigated the outbreak at two Florida hospitals, CRE was a CRE was a newly emerging superbug. Sanderson traced the infections to patients who had undergone a procedure in which a duodenoscope is inserted down the throat to treat upper-intestinal blockages, such as gallstones or tumors. Sanderson found that technicians cleaning duodenoscopes did not follow protocols for cleaning the "elevator" mechanism, which controls tiny tools that remove blockages or insert stents in intestinal ducts. The mechanism must be carefully purged of biological debris. Sanderson reported that investigators had found accumulated tissue in the channel that was rife with bacteria, including CRE, according to USA Today. Patients who had been treated with the scope were at risk of infection.

In 2008, the CDC issued a broad guidance document on hospital disinfection that specifically noted the challenges of cleaning duodenoscopes properly. Co-author William Rutala, an infection control expert at the University of North Carolina Hospitals says, "no other instrument has such a narrow margin of safety."

Last week, an FDA advisory panel reached a broad consensus that duodenoscopes cannot be disinfected reliably under existing guidelines. But panelists nonetheless endorsed the FDA's decision to encourage continued use of duodenoscopes. They expressed broad agreement that infection risks are low and the device remains the safest, least invasive way to perform important, potentially life-saving procedures, according to USA Today.

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