Duodenoscope Infection Risk

The US Food and Drug Administration (FDA) has issued a warning that duodenoscopes could be linked to the spread of deadly bacteria. This warning concerns ERCP endoscopes, also known as duodenoscopes, and comes on the heels of reports of serious multi-drug resistant bacteria in patients who had medical procedures involving the medical devices. Duodenoscope lawsuits have now been filed after patients reportedly developed infections linked to devices.

On February 19, 2015, the FDA warned that the complex design of ERCP endoscopes may prevent them from being properly sanitized, even when manufacturer recommended sanitation guidelines are followed.

"Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it," the FDA warned.

The agency noted that from January 2013 to December 2014 it received 75 medical device reports involving around 135 patients who suffered a possible microbial transmission from duodenoscopes. The FDA said it will continue to monitor the association between duodenoscopes and infectious agents.

One medical center linked to the outbreak is Ronald Reagan Medical Center at UCLA. The medical center said seven patients were infected by a bacteria linked to duodenoscopes. Two people reportedly died and 179 others may have been exposed, according to the Los Angeles Times (2/25/15).

Duodenoscopes are lighted tubes inserted in a patient through the mouth to the top of the small intestine. They are used during endoscopic retrograde cholangiopancreatography (ERCP), a procedure involved in diagnosing and treating problems of the pancreas and bile ducts.

Because the duodenoscopes have many small parts, tissue or fluid from one patient can remain on a duodenoscope even after it is cleaned. This can result in a patient-to-patient infection. The FDA has said that the infections have occurred even after medical professionals followed proper manufacturer cleaning instructions.

An 18-year-old who developed a CRE (carbapenem-resistant Enterobacteriaceae) infection after undergoing a procedure involving a duodenoscope has filed a lawsuit against Olympus, maker of the device. According to the Los Angeles Times, although Olympus redesigned its duodenoscope it did not provide proper cleaning guidelines for the product.

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Last updated on Mar-17-15