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.