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ERCP Duodenoscopes Linked to Superbug Infections

Personal Injury Lawsuit: Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes Linked to Superbug Infections

Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes Linked to Superbug Infections

Our firm is investigating lawsuits on behalf of patients infected with a multidrug-resistant bacteria, CRE.

Our firm is investigating potential lawsuits on behalf of patients who were infected with a multidrug-resistant bacteria, such as Carbapenem-Resistant Enterobacteriaceae (CRE), associated with the use of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes. These devices, which are inserted down a patient's throat for certain medical procedures, have been implicated in several "superbug" outbreaks. The devices have also come under intense scrutiny as a growing body of evidence reveals that they cannot be completely sterilized, even when following manufacturer's instructions. If you or someone you know suffered an infection linked to an ERCP endoscope, contact Parker Waichman LLP today.

FDA Warns that Scopes Can Spread Multidrug-Resistant Bacteria

Duodenoscopes are long, flexible instruments that are inserted through the patient's throat to diagnose and treat disorders of the digestive tract, including gallstones, cancers, and bile duct blockages; the devices are used in a procedure called ERCP.

In February 2015, the U.S. Food and Drug Administration (FDA) announced that the complex design of duodenoscopes may impede effective sterilization of the devices. The agency stated that the devices may spread bacterial infections to patients even if the duodenoscopes are cleaned meticulously and manufacturers' instructions are appropriately followed. "Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it," the agency wrote.

According to the safety notification, the FDA received 75 medical device reports involving 135 patients between January 2013 and December 2014 related to potential infections spread by duodenoscopes. The FDA stated that it was "closely monitoring the association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia coli."

Superbug Outbreaks Linked to Duodenoscopes

Contaminated duodenoscopes were linked to two superbug outbreaks in 2015. At UCLA's Ronald Reagan Medical Center and Cedars-Sinai hospital in Los Angeles, a total of 11 patients were infected with CRE and 246 additional patients were potentially exposed. CRE is a so-called "superbug" that is highly resistant to antibiotics; may kill up to 50 percent of infected patients; and falls into a type of bacteria considered "gram-positive," meaning the bacteria has a thick cell wall, making the bacteria very difficult to kill with antibiotics.

A report published in The Association of Health Care Journalists found that 9 of 113 patients at Advocate Lutheran General Hospital in Park Ridge, Illinois exhibited "signs and symptoms of" CRE after undergoing ERCP procedures. The report noted that the hospital did not follow the manufacturer's guidelines for reprocessing.

In 2014, a study published in The World Journal of Gastrointestinal Endoscopy focused on the risk of transmitting CRE and other superbugs during gastrointestinal endoscopy. The review involved reports of outbreaks linked to GI endoscopes over the course of 30 years, and found that the endoscopes were an important risk factor in CRE infection. The scopes were linked to patient morbidity and mortality following ERCP.

Legal Advice for ERCP Duodenoscope Patients

If you were, or someone you know was, infected with CRE or another multidrug-resistant bacteria after a procedure involving an ERCP duodenoscope, we urge you to contact Parker Waichman LLP for a free, no-obligation evaluation of your case. For more information, fill out our online form to the right or call one of our experienced personal injury attorneys today at 1(800)968-7529.


ERCP Duodenoscopes Linked to Superbug InfectionsRSS Feed

Olympus Allegedly Neglected to Alert U.S. Users of Tainted Medical Scopes

Jul 26, 2016
As early as 2013, Japanese device giant Olympus Corporation was aware of superbug outbreaks in three counties and did not issue a warning to American hospitals about possible deadly infections from tainted medical scopes (duodenoscopes). Following two dozen infections reported in French and Dutch hospitals, Olympus alerted European customers that their medical scopes could become contaminated, reports the Los Angeles Times. Concern grew when a similar outbreak occurred at a Pittsburgh...

FDA Continues to Advise against use of Custom Ultrasonics Duodenoscope Reprocessor

Feb 26, 2016
Following a mandatory recall, the U.S Food and Drug Administration (FDA) is asking hospitals to stop using Custom Ultrasonics duodenoscope reprocessors. Duodenoscopes are devices that are snaked through the gastrointestinal tract to visualize and treat problems in the duodenum, the first section of the small intestine. The devices came under increased scrutiny after they were linked to outbreaks of CRE bacterial infections; these are "superbugs" resistant to antibiotics. In November, the FDA...

New Senate Report Critical of Device Makers Hospitals and FDA in Superbug Outbreaks

Jan 15, 2016
An investigative report released on January 13, 2016 by Senator Patty Murray criticizes medical device makers, hospitals and the Food and Drug Administration (FDA) for their roles in superbug outbreaks linked to inadequately cleaned medical devices. Sen. Murray, of Washington, launched the investigation of duodenoscopes after a cluster of infections in Seattle, the New York Times reports. Duodenoscopes, which can be difficult to clean and sterilize between uses, were linked to at least 250...

Olympus Fails to Warn US Hospitals about Risk of Infection with Duodenoscopes

Dec 30, 2015
The duodenoscope debacle continues to grow, as an LA Times investigation reveals that scope maker Olympus failed to warn US hospitals about the risk of infection with its TJF-Q180V duodenoscope. According to LA Times, Olympus became aware of potential infections in 2012 when a technician found a film of bacteria inside a scope at a Netherlands hospital. The device was suspected to be the source of an infection that sickened 22 patients, Qmed reports. The technician also discovered that the...

Wrongful Death Lawsuit Filed over Infection Linked to Duodenoscope

Nov 25, 2015
The family of a man who died from an antibiotic-resistant bacterial infection following a routine medical procedure has filed a wrongful death lawsuit against Olympus America, Olympus Medical Systems Corp., and Custom Ultrasonics. The lawsuit was filed on November 20, 2015, in United States District Court for the Eastern District of Pennsylvania. The man had undergone endoscopic retrograde cholangiopancreatography (ERCP) at Carolinas Medical Center in Charlotte, North Carolina. During an ERCP,...

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