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As deadly outbreaks of “superbug” infections become increasingly common, the FDA is warning about disease-transmission on duodenoscopes that are extremely difficult to sterilize.

What is a Duodenoscope?

A duodenoscope is a type of endoscope — a long, flexible tube about the diameter of a pen that is outfitted with a tiny light and camera at the tip.

They are inserted into a patient’s mouth, throat, and past the stomach into the upper part of the intestine. The scope is most often to drain bile and pancreatic ducts that are blocked by tumors or gallstones.

What is an ERCP?

Endoscopic retrograde cholangiopancreatography (ERCP) is a medical procedure that uses a duodensocope and fluoroscopic imaging to diagnose or treat diseases involving the pancreas and bile ducts.

During an ERCP, a special type of “side-viewing” duodenoscope is used. This scope is outfitted with a catheter in an instrument channel. Instruments are used to remove gallstones, for example, or insert a stent into a blocked bile duct.

These scopes also have a movable “elevator” mechanism at the tip. The elevator mechanism changes the angle of the instrument, which allows the instrument to access the ducts to treat problems with fluid drainage.

FDA Warning for “Superbug” Infections

In February 2015, the FDA issued a Safety Communication to warn that duodenoscopes have a “complex design” that may be “extremely difficult” to sterilize effectively:

“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.”

What is the problem?

More than 500,000 duodenoscope procedures are done every year in the United States. From January 2013 through December 2014, the FDA received 135 reports of patients who had microbial transmission from reprocessed duodenoscopes, but it is likely that many cases were never reported.

The superbug, Carbapenem-Resistant Enterobacteriaceae, or CRE, can kill up to 50% of people who develop infections. The bacteria recently evolved an enzyme that deactivates nearly all antibiotics. It wasn’t until spring 2013 that the Centers for Disease Control (CDC) recognized CRE as a nationwide threat.

Unfortunately, outbreaks of antibiotic-resistant bacteria are becoming more common.

In February 2015, an outbreak of CRE infected seven people in Los Angeles, including two who died. About 179 people were exposed to the deadly bacteria after undergoing ERCP procedures at UCLA’s Ronald Reagan Medical Center. A similar outbreak in North Carolina infected three people, including one person who died.

Just one month earlier, a similar outbreak was traced to dirty scopes at Seattle’s Virginia Mason Medical Center. Between 2012 and 2014, at least 35 patients were infected. Eleven deaths were linked to those infections, but it is not clear that the deaths were directly related to the superbug infection.

From March-July 2013, at least 44 patients developed CRE infections at Advocate Lutheran General Hospital in Chicago, Illinois, including 38 patients who had endoscopic procedures.