35 E. coli Cases Linked to Duodenoscopes Used for ERCP

Apparently, for at least 35 patients, duodenoscopes used in procedures were not sterile and caused an outbreak of E. coli illnesses, according to an article in JAMA* published this week. A duodenoscope is a specialized endoscope that does endoscopic retrograde cholangiopancreatography (ERCP), which is used to diagnose and treat problems in the bile and pancreatic ducts.

E. coli Outbreak Linked to Dirty Duodenoscopes

Between January and December of 2013, 35 people tested positive for NDM-producing E. coli (highly drug resistant) after having ERPC using a duodenoscope.

All 35 of the patients with E. coli had the ERCP at one hospital.

The researchers determined the hospital followed all manufacturer-recommended “reprocessing” instructions to ensure sterilization prior to using the duodenoscope. With all 35 cases in one hospital, though, one of the following is true:

  1. The hospital did not follow all of the reprocessing procedures; or
  2. The hospital followed the manufacturer’s instructions, but the instructions are faulty and the reprocessing methods provided by the manufacturer do not adequately sterilize the product.

If it is #1, the patients who contracted E. coli infections have medical malpractice claims against the hospital. There appears to be sufficient evidence that this outbreak of illnesses is linked to the hospital. Patients would be able to sue the hospital for malpractice.

If it is #2, the patients would have product liability claims against the manufacturer of the duoenoscopes. This is a bit of a tricky claim with medical devices because of a recent U.S. Supreme Court ruling. Having only one hospital involved in the outbreak also makes the cases more difficult. The claims would be much better if patients from other hospitals also contracted the same type of E. coli.

Interestingly, after the hospital changed to a gas sterilization method (instead of the method recommended by the manufacturer), no other patients were diagnosed with the NDM-producing E. coli after undergoing a duodenoscope procedure. This is evidence that the manufacturer’s recommendations were inadequate to prevent the outbreak.

Any patient who contracted an E. coli infection after a medical procedure should contact their local health department and our law firm.

These cases of E. coli may be the “tip of the iceberg” as 2 doctors from University of North Carolina Health Care wrote in an accompanying editorial.  There may be more patients who contracted infections from NDM-producing E. coli, or another dangerous pathogen, including MRSA.

With the rise of drug-resistant bacteria, it is critical that hospitals and manufacturers take every measure to prevent the spread of disease.


* Journal of the American Medical Association, October 8, 2014, Vol 312, No. 14.

Share this article:

Category: Product Liability
Ready to talk?

We're here to listen. Tell us what happened to you.

We are not paid unless you win. Submitting this form does not create an attorney-client relationship.

Related Articles

Leave a Reply