W&L Investigates Duodenoscopes That May Cause Serious InfectionsFebruary 27th, 2015
W&L today began investigating possible claims against the manufacturers of special types of duodenoscopes, known as ERCP duodenoscopes. News recently broke that the medical instruments are capable of harboring a potentially deadly strain of a rare antibiotic-resistant “superbug” bacteria, as well as other infections. This bacteria, which is known as carbapenem-resistent Enterobacteriaceae (CRE), is now implicated in deaths and serious illnesses across the nation.
In January, seven patients at UCLA’s Ronald Reagan Medical Center in Los Angeles developed symptoms of the bacterial infection after having undergone procedures with the ERCP duodenoscopes. Two of them reportedly died from their infections.
The Los Angeles Times reports that, since 2012, a half-dozen outbreaks affecting up to 150 patients have occurred in Washington, Illinois and Pennsylvania.
The Times characterizes the superbug outbreak as serious because it can be difficult to detect and treat. It is lethal in as many as half the people who catch it, as it is resistant to most antibiotics, if it finds its way into the bloodstream.
The Times quoted one hospital safety consultant as saying the breadth of the recent outbreaks is unprecedented and could add up to the “most significant instance of disease transmission ever linked to a contaminated reusable medical instrument.”
ERCP Duodenoscopes Have Possible Design Flaw
The outbreak of the antibiotic-resistant Enterobacteriaceae superbug at UCLA, as elsewhere, is believed to be due to a possible design flaw that allows germs to survive the ERCP duodenoscope manufacturer’s recommended cleaning process, The Times reports. Though many reports detail that hospitals have diligently followed manufacturer-specified cleaning procedures, bacteria has still been found on ERCP duodenoscopes.
The newspaper wondered whether medical device companies and others have done enough to protect patient safety. W&L attorneys probing the problem say it is looking more and more as though they have not.
Among other things, ERCP duodenoscopes are used more than 500,000 times per year in the U.S. to perform a procedure called an endoscopic retrograde cholangiopancreatography, or ERCP.
In an ERCP, a doctor can drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other conditions, according to the U.S. Food and Drug Administration.
The FDA describes an ERCP duodenoscope as a flexible, lighted tube that is fed into a patient’s mouth, down the throat, through the stomach, all the way to the small intestine for a view of the duodenum.
The devices allow for the attachment of instruments at their tips. The instruments are adjusted into various angles with the aid of the ERCP duodenoscope’s movable platform, or elevator.
FDA Expresses Duodenoscope Concern
The FDA indicates that the design of ERCP duodenoscopes as well as the elevator mechanism is “complex.” It attributes the cleaning difficulty users encounter to this complexity.
In a Medical Devices Safety Alerts and Notices statement issued on Feb. 19, the FDA revealed that a recent engineering assessment it conducted “identified design issues” in ERCP duodenoscopes.
These design issues are believed responsible for allowing the CRE superbug and other strains of bacteria to survive the manufacturer’s recommended cleaning process, potentially allowing for bacteria and infection to spread from one patient to the next when undergoing procedures that utilize the reusable ERCP duodenoscopes.
USA Today reports that other germs and viruses besides the antibiotic-resistant Enterobacteriaceae may be transmitted from contaminated duodenoscopes. A review of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, through which consumers and healthcare providers can submit adverse event and other reports to the FDA, reveals that cases of cleaning problems, contamination and infection were reported to the FDA regarding ERCP duodenoscopes as early as 2012.
As of February 26, one manufacturer of ERCP duodenoscopes, Olympus, has had two lawsuits filed against it by patients who were infected with CRE after undergoing procedures in which its ERCP duodenoscope was used.
W&L welcomes calls from patients who believe that they may have become ill after an ERCP duodenoscope procedure or any other in which an ERCP duodenoscope was utilized.
UPDATE: On March 4, 2015 there was a new story in The Times revealing that another area hospital had discovered patients who had probably been infected by ERCP duodenoscopes. Cedars-Sinai Medical Center disclosed that four people were infected with the possibly fatal bacteria and 67 more were exposed.
On that same day, the FDA issued Updated Information for Healthcare Providers Regarding Duodenoscopes. It acknowledged that there is a pending 510(k) application by Olympus for this device that, though the application is still under review, is already being marketed by the company. The update also reiterated the importance of properly cleaning and sterilizing these instruments, and emphasized the risk of infection to patients undergoing an ERCP duodenoscope procedure.