Lieff Cabraser Civil Justice Blog

CRE Superbug Infections: Update On Outbreak From Contaminated Endoscopes

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Across the nation, from Seattle to Pittsburgh to North Carolina and Florida, hospital officials have revealed that patients have tested positive for drug-resistant “superbug” bacteria after being examined with a special kind of endoscope, called a duodenoscope. At the same time, some of these same officials assert that they have no evidence the medical scopes at their facility actually transmitted the infections.

Yet, the linkage between infections and contaminated medical scopes is well known. In 2009, the FDA warned hospitals and physicians about the risks to patients if flexible endoscopes and their accessories were not cleaned properly and recommended steps to reduce these risks. The following year, physicians in France reported in the medical journal Endoscopy that duodenoscopes “can act as a reservoir” for bacteria.

Duodenoscopes are used in ERCP procedures, and more than 500,000 of these procedures occur annually in the U.S. The duodenoscope is used to diagnose and treat certain problems of the liver, bile ducts, and pancreas, such as stones, narrowing, tumors, and blockages. Patients with pancreatitis and pancreatic cancer often receive ERCP.

After every procedure, the duodenoscope must be “reprocessed” before the scope can be used on a new patient. Reprocessing is a detailed, multistep, manual process to scrub and clean the medical scopes, followed by a soaking in disinfecting fluid. If the scope is not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope and spread a deadly superbug infection.

Even with rigorous cleaning, however, deadly germs can remain on duodenoscopes. At Virginia Mason Medical Center in Seattle, the superbug CRE, an abbreviation for carbapenem-resistant Enterobacteriaceae, was spread by contaminated scopes and infected 32 patients, including 11 who died. As explained by Bloomberg News, the hospital began taking the devices, known as ERCP endoscopes or duodenoscopes, out of service for 48 hours between procedures and culturing them to check for bacteria. Even with more diligent cleaning, 3 percent of the scopes tested positive for contamination and had to be re-cleaned.

“We suspect endoscope-associated transmission of pathogenic bacteria might be both more common than recognized and not adequately prevented by current endoscope reprocessing guidelines,” researchers from the Centers for Disease Control, Virginia Mason Medical Center, and Seattle public health authorities wrote in a recent report.

Why are duodenoscopes spreading superbugs?

In lawsuits filed against the manufacturers of the devices, the plaintiff charge that the duodenoscope are defectively designed. The latest versions of duodenoscopes have a sealed part near the tip, known as the “elevator channel.” Bacteria can become lodged in the elevator channel and be spread from one patient to another, as the elevator channel is not accessible for cleaning and disinfection during reprocessing.

Contact Lieff Cabraser Actos Lawyers

If you or a family member developed CRE following an endoscopic procedure, please use the form on our endoscopes case page to contact an experienced injury lawyer at Lieff Cabraser to discuss your case. There is no charge or obligation for our review, and all your information will be held in the strictest confidence.

You are also welcome to call us toll-free at 1-800-541-7358 and ask to speak to me, Lexi Hazam, or my colleague Fabrice Vincent.

By Lexi Hazam.