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Duodenoscope Lawsuit


As outbreaks of antibiotic-resistant “superbugs” become more and more common, the FDA is warning that some duodenoscopes pose a safety hazard because they are nearly impossible to sterilize between uses.

What is a Duodenoscope?

A duodenoscopes is a long, flexible tube about the diameter of a pen that is equipped with a tiny camera, light, and instruments at the tip. It is a type of endoscope that it is inserted into a patient’s mouth and carefully guided past the stomach, into the upper part of the intestines. It is most often used to treat digestive diseases, such as gallstones and pancreatic cancer.

What is an ERCP?

Duodenoscopes are used in a medical procedure called an Endoscopic Retrograde Cholangiopancreatography (ERCP), which uses fluoroscopic imaging to diagnose diseases involving the pancreas and bile ducts.

Specialized “side-viewing” duodenoscopes are used in ERCP procedures. At the tip of the scope, there is a catheter in a channel that can deploy instruments. The instruments are attached to a moveable “elevator” mechanism that can change the angle of the instrument to remove gallstones, insert a stent, or open up a blocked bile duct.

FDA Warning: ERCP Duodenoscopes and “Superbug” Infections

Since 2009, at least five major outbreaks of “superbug” infections have been traced to dirty duodenoscopes. In February 2014, the FDA published a Safety Communication and warned that the complex mechanisms in the tip of the scope may be extremely difficult to sterilize.

As antibiotic-resistant “superbugs” become increasingly common, duodenoscopes pose a safety hazard. According to the FDA:

“The moving parts of the elevator mechanism contain microscopic crevices that may not be reached with a brush. … Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection. If these fluids contain microbial contamination, subsequent patients may be exposed to serious infections.”

How Common is Disease Transmission on Duodenoscopes?

Duodenoscopes are used in about 500,000 procedures in the United States every year. Between January 2013 and December 2014, the FDA received reports of bacterial transmission from duodenoscopes in 135 patients. However, they cautioned that this may underestimate the actual number of cases.

Duodenoscope Infection Outbreaks

CRE, or Carbapenem-Resistant Enterobacteriaceae, is a family of “superbug” bacteria that have recently evolved a resistance to nearly all antibiotics. An estimated 50% of infections are fatal.

In February 2015, at least 179 people were exposed to CRE after undergoing ERCP duodenoscope procedures at a hospital in Los Angeles. Seven patients developed infections and two patients died. Meanwhile, at least 3 people were infected with CRE and one person died in North Carolina.

In January 2015, officials at Virginia Mason Medical Center in Seattle reported that 35 patients were exposed to CRE after undergoing duodenoscope prodceures in 2012 and 2014. At least 11 patients died after developing infections, but it is not clear that the infection caused all of the deaths.

In mid-2013, an outbreak of CRE at Advocate Lutheran General Hospital in Chicago, Illinois, infected at least 44 patients. Of those patients, 38 had recently undergone an endoscopic procedure.

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