Today’s video is an update on endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes that have been linked to infections of the superbug CRE, or Carbapenem-resistant Enterobacteriaceae (bacteria in the family Enterobacteriaceae that are highly resistant to Carbapenem antibiotics, including certain types of E. coli and Klebsiella).
Today the FDA issued a number of documents about this outbreak and about procedures to sanitize these devices. We believe that the FDA is being especially proactive in its communications now because of criticism of the agency for not reacting fast enough, or not being proactive enough about alerting the public.
Another new development today is the fact that Cedars-Sinai hospital in Los Angeles has been identified as another site of these infections. Reports indicate that at least one person has died who got an infection from an ERCP duodenoscope at this hospital.
Another piece of information is that Olympus, which is the maker of one of the duodenoscopes linked to an outbreak of CRE infections at UCLA, has come out today that they had not sought appropriate FDA clearance for marketing and selling this device, which is a very disconcerting piece of information, especially about a device that has been linked to deadly infections.
Also we learned today that Virginia-Mason Hospital, which is a hospital in Seattle and which has also been a site of one of these outbreaks almost a year ago, may not have notified patients that their infection may have been linked to this device and the CRE superbug. If this holds true, it is profoundly disturbing that such information was withheld from patients. Our law firm is representing a number of people who have been sickened or died as a result of these infections. If you have any questions or you would to get a free consultation about these cases, please call us toll free 888-377-8900 or you can email me at fhp@pritzkerlaw.com, thank you.