2017-03-13T15:17:30+00:00Pritzker Hageman, P.A.Fred Pritzker 45 S 7th St, #2950 Minneapolis, MN, 55402 U.S.A +1.612.338.0202

The Olympus duodenoscope (ERCP endoscope) , TJF-Q180V, has been linked to an outbreak of CRE infections at UCLA.  At least 7 patients were infected at UCLA Ronald Reagan Medical Center. Two of the 7 died. Carbapenem-resistant Enterobacteriaceae, also referred to as CRE, are a bacteria from the Enterobacteriaceae family that have become extremely resistant to antibiotics, even the kind used as a last resort, carbapenem. So all standard antibiotic treatments are ineffectual, and about 40% of patients with this infection die.

These duodenoscopes are used for endoscopic retrograde cholangiopancreatography (ERCP). Olympus, Fujifilm and and Pentax manufacture and market these scopes. The FDA issued a safety communication stating there are problems with cleaning these devices. And it came out this week that the Olympus TJF-Q180V duodenoscope was not approved for sale by the FDA.

These Olympus TFJ-Q180V duodenoscopes were sold and marketed without FDA approval. The company made modifications to an older model and did not take measures to get the new model approved.

Karen Riley, deputy director of strategy for the FDA’s Office of External Affairs, told CNN, “Why didn’t we notice it? I don’t know.”

Our lawyers are investigating lawsuits for CRE infection from ERCP endoscopes.

Lawsuits have been filed against Olympus America Medical, one on behalf of an 18-year-old and one on behalf of the family of a woman who died. Both were patients at UCLA.

UCLA was not sued. It claims it followed instructions for cleaning provided by Olympus. The lawsuit alleges the instructions provided with the Olympus Q180V used in the UCLA procedures were instructions for an older model.

CRE Infection Outbreak Information

The FDA has said it received reports of about 135 patients in the U.S. getting infections from “reprocessed” (cleaned) duodenoscopes from January of 2013 to December of 2014.  There are many more than this, however, because hospitals are not required to report CRE infections and they have not been notifying patients that they were sickened by these devices.

Three recent CRE outbreaks linked to ERPC duodenoscopes have been reported:

  • UCLA Ronald Reagan Medical Center has 7 confirmed cases, 2 of whom died, and has notified 179 others who may have been infected;
  • Cedars-Sinai Medical Center in Los Angeles has 4 confirmed cases, one of whom has died, and almost 70 others could have been infected;
  • Virginia Mason Medical Center in Seattle has 32 confirmed cases, 11 of whom died, from either CRE or a specific kind of E. coli infection from Hyper-AmpC producing E. coli.

CRE infections can involve any bacteria in the Enterobacteriaceae family, including Salmonella, E. coli, Yersinia, Klebsiella, Shigella, Proteus, Enterobacter, Serratia, and Citrobacter.

 

Sources:
1. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm
2. http://www.cnn.com/2015/03/04/us/superbug-endoscope-no-permission/