Emails Show FDA Was Warned of Duodenoscope Infection Risks Six Years Ago

 Emails Show FDA Was Warned of Duodenoscope Infection

Emails Show FDA Was Warned of Duodenoscope Infection

The Food and Drug Administration (FDA) received warnings nearly six years ago about the risk of “superbug” infection from specialized medical scopes. The devices have been tied to a series of deadly superbug outbreaks.

In 2009, after duodenoscopes were linked numerous drug-resistant infections in Florida hospital patients (and to 15 deaths), 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, USA Today reports.

In an email sent to six FDA officials on April 22, 2009, Arjun Srinivasan, a CDC infection control expert, wrote, “This is likely not an issue limited to FL hospitals and it’s quite concerning.” Srinivasan urged a joint “educational alert” from the CDC and the FDA. Seven months later, in a general advisory on cleaning and disinfection of medical scopes, duodenoscopes received a brief mention in paragraph 57. These specialized scopes are used annually in about 650,000 procedures in the bile and pancreatic ducts, USA Today reports. 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.

Despite the 2009 warnings, it was not until winter 2015 that the FDA issued a specific alert about contamination risks that can persist even in a duodenoscope that has been meticulously cleaned. 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). CRE has mortality rates of 40 percent or more.

FDA officials say the 2009 advisory was adequate based on information at the time and it was not until September 2013 that they had sufficient evidence for 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 says the FDA ignored “red flags” and he has requested congressional hearings. Lieu says the FDA “should have begun issuing safety alerts and had the manufacturers look at (developing) new designs.”

CRE was a newly emerging superbug at the time Roger Sanderson investigated the outbreak at two Florida hospitals. He 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. Investigators at one hospital found accumulated tissue in the channel that was rife with bacteria, including CRE, according to USA Today. Patients 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 consensus that under existing procedures duodenoscopes cannot be reliably disinfected. But the panel nonetheless endorsed the FDA’s decision to encourage continued use of duodenoscopes. Panelists said the 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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