Faulty design and cleaning procedures in widely used endoscope may have caused superbug outbreak
By Farid Zakaria, Keller, Fishback & Jackson LLP
An outbreak of a drug-resistant strain of bacteria at a major southern California hospital last February has been linked to a medical device used in the treatment of cancers, gallstones, and other ailments of the digestive system.
On February 18, the Los Angeles Times reported that nearly 180 patients who were treated with endoscopes at UCLA’s Ronald Reagan Medical Center may have been exposed to CRE (carbapenem-resistant Enterobacteriaceae), a bacteria which according to some estimates can kill 40% to 50% of infected patients.
The instrument linked to the UCLA outbreak is a duodenoscope that is used to diagnose and treat problems of the ducts that carry bile and pancreatic fluid. Medical experts say its complex design makes it difficult to disinfect, resulting in bacteria being transmitted from patient to patient.
The device contains a video camera and a small “elevator” designed to maneuver precision instruments into tiny ducts. A little pocket behind the elevator and a thin cable connected to the elevator are thought to be potential sites for contamination.
Endoscopes are inserted down the throats of about 500,000 patients annually in the United States in a procedure known as ERCP, or endoscopic retrograde cholangiopancreatography, which is distinct from routine endoscopy and colonoscopy.
According to UCLA, the first patient infected with CRE was identified last December but it took until January 28 for doctors to confirm the infections were tied to the medical scopes used in ERCP.
So far, UCLA has confirmed seven CRE infections.
The risks associated with endoscopes have been known for some time. In October, a study in the Journal of the American Medical Association linked bacterial infections to duodenoscopes at an Illinois hospital, even though researchers found no cleaning lapses. And the FDA has known about the problem for more than 2 years; between January 2013 and December 2014, it received reports of 135 patients potentially infected by contaminated scopes.
Following the bacterial outbreak in Illinois, the FDA requested in 2014 that Olympus, the market leader in duodenoscopes and UCLA’s supplier, provide proof that its devices could be cleaned adequately. Responses submitted by Olympus on two separate occasions were deemed insufficient.
What’s more, Olympus redesigned its duodenoscope in 2010 but never tried to get the necessary government clearance, the FDA said.
The FDA now recognizes that the scope linked to the UCLA outbreak may be so flawed that it cannot be properly cleaned.
One 18-year old patient who was first diagnosed with CRE last October after he was treated with a scope at UCLA has filed a lawsuit against Olympus, claiming that it failed to provide the hospital with appropriate cleaning instructions. The patient remains hospitalized while battling the infection.
Another lawsuit has been brought against Olympus by the family of a 48-year old woman who died on November 8 after being exposed to a contaminated scope at UCLA in October. The lawsuit alleges that Olympus marketed a “defective” device.
In light of the UCLA outbreak, many hospitals are investigating infections for possible links to contaminated endoscopes. On March 4, Cedars Sinai Medical Center said it had discovered that four patients were infected with CRE and 68 more people may have been exposed to the bug after being treated with Olympus scopes. One of the 4 patients has died.
If you were treated with an endoscope and became infected with CRE or other life-threatening bacteria, contact attorney Dan Bolton or Farid Zakaria of the law firm of Keller, Fishback & Jackson LLP at 1-800-LAW-4-YOU for a free, confidential consultation.