FDA investigates endoscopes linked to "superbug" infections

Seven patients have been infected with a drug-resistant “superbug” at UCLA’s Ronald Reagan Medical Center since last fall. Two patients have died, and public health officials are tracking down an additional 200 who might have been exposed.

Officials suspect a specialized endoscope, called a duodenoscope, is responsible for the infections. The instrument is used across the United States to open and drain small ducts that empty into the duodenum from the pancreas in patients with cancer or gallstones.

This is just the latest outbreak of infections associated with the duodenoscope and caused by a bacteria called CRE, carbapenem-resistent Enterobacteriaceae. It is resistant to practically all available antibiotics and has an almost 50 percent fatality rate in blood-borne infections.

The duodenoscopes, unlike the more common endoscopes, have a specialized tip that allows doctors to enter the small ducts of the pancreas. This specialized modification is extremely difficult to sterilize and is thought to be the source of the infections. Between January 2013 and December 2014, the Food and Drug Administration (FDA) has received 75 additional reports of CRE infections after using the same instrument.

The FDA has emphasized the need to carefully follow the sterilization procedure after each use, but the infections have occurred despite sterilization, indicating it’s not sufficient to eliminate the problem.

The FDA does not have plans to pull the scopes from use. Officials cite the relatively few number of infections compared to the vast number of procedures performed, as well as the clinical benefit for thousands of patients whose alternative would be a more serious surgical procedure.

But regulators are continuing to investigate the issue and might recommend modifications to the process for using the device.

Meanwhile, an 18-year-old student, one of seven sickened so far, is struggling to avoid being the third fatality in the UCLA outbreak. He has spent the last three months in the hospital. Similar infections involving the same instrument and bacterial organism have been noted in Chicago and Seattle.