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Faulty design and cleaning procedures in widely used endoscope may have caused superbug outbreak

CRE bacteria, Source: CDC

CRE bacteria, Source: CDC

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.

Olympus Dudenoscope

Olympus Dudenoscope

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.

ERCP endoscope tip, CDC

ERCP endoscope tip, CDC

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. keller jackson logo

 

5 Comments

  1. Dorothy says:

    I can’t believe my luck. Last Wednesday April 1 I received a procedure at Ann Arbor Hospital. It’s the 5th one I’ve had. A spot on my pancreas has required this procedure every year. My Doctor told me after 5 we can stop if I want. The procedure is an Upper Endoscopy (EDG) with Endoscopic Ultrasonograpy (EUS) with Anesthesia. What should I do Jane.

  2. Aaron Leigh says:

    Thank you Jane. I agree this is information VERY important for our community to have. Even UCLA was an offender. We need to hold all our providers to the standard of care, ESPECIALLY for sterilization and hygiene protocol in hospitals!

    • Jane akre says:

      And all of that training comes from the manufacturers! If it can’t be sterilized, it is unusable in the hands of its intended users,,, ie doctors and therefore is defective!

  3. Richard Howden aka All Meshed Up says:

    As a male I have a few Colonoscopy procedures, all at the VA here in Grand Junction Co.. I am surprised there are not more problems here other than the occasional punctured bowel. Yes, punctured bowels either by the probe or by sloppy technique when trying to remove a cyst or such is quite common at least at this VA.. For a number of years they were not even allowed to do these exams and a few other procedures because they had no surgical backup in case there was a major problem!

    I walked out of pre-op here after watching everyone around me go, come back, leave and be replaced again whilst I sat there in my gown awaiting my turn. I then heard my Doctor say he was leaving for lunch. I was the first patient in pre-op that morning and it was now 11:45 and my Dr. just left for a sandwich. 2 hours 45 minutes! I walked out into the hallway, carting my IV along with me and my white butt sticking out the back and yelled” GET MT THE %@*&$ OUTTA HERE!”. They still talk about me in pre-op. Looking back it’s funny. It wasn’t at the time. Just thought I would share!

    • Kitty says:

      Richard —you are a hoot I guess i had a little more class when my urologist left for emergency in the OR and then came back with lunch for the office crew—atre with them —- and then saw me and told me I should be on antidepressants when I infoormed her things were not going well after she cut my sling and I asked her “where were the anchors? I was only waiting 2 hours though. Luv Ya

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