Olympus Corp., manufacturer of the TJF-Q180V duodenoscope, might have known about a risk involving their product at least two years ago. At least that’s when it issued letters to European hospitals warning that, without proper cleaning, it’s a possibility that Olympus duodenoscopes carry deadly disease.
Unfortunately, in the U.S. that possibility may have become a reality. A “super-bug” outbreak affecting only patients upon whom the duodenoscopes had been used surfaced between October 3, 2014 and January 28 of this year. The patients, at UCLA’s Ronald Reagan Medical Center in L.A., had a procedure known as endoscopic retrograde cholangiopancreatography (ERCP) after which they contracted carbapenen-resistant Enterobacteriacieae (CRE). Two of the patients died, seven others became very sick and another 179 were told they might have been accidentally exposed to CRE.
The flexible, side-viewing scopes are necessary “tools of the trade” for upper GI work. However, the design makes them almost impossible to clean completely. In fact, the hospital in L.A. now has what the Los Angeles Times calls “one of the most stringent scope protocols in the United States.” The scopes are manually cleaned and “high-level” disinfected, as well as being sent offsite for sterilization using ethylene oxide (EtO) gas. No new cases of CRE have surfaced at the facility since putting the new protocol into place.
The really nasty part of all of this (aside from the killer bacteria and dead patients) is that Olympus warned European hospitals two years before the first CRE infections were reported in the U.S. However, no U.S. facilities were warned. The first notice was a 2013 letter warning of the risks of improper cleaning and giving recommended cleaning practices.
The second letter was in the summer of 2014 and addressed complaints that the recommended practices were leaving the scopes dirty. This warning specifically mentioned the elevator section of the scope, a high-risk area for bacteria according to the FDA.
Olympus finally sent a warning to U.S. users in February 2015, after the CRE outbreak. Speaking of the FDA, what was it doing during all this? The Times says that the FDA admits to knowing about the European warnings as early as last summer. However, it chose to do nothing as officials were working with scope producers to provide best-level cleaning protocols. Olympus just released new protocols in March of this year.
This is, as my mother was fond of saying, closing the barn door after the horses get out.
It’s appalling (on so many levels) that Olympus felt it unnecessary to warn U.S. hospitals along with the European hospitals. I strive to find the logic in such a move. I’m not a doctor, but the last I knew anatomy and physiology didn’t differ simply based on one’s continent of birth. If the dirty scopes (ugh!) were a risk for European derrières, then why not for North American buttocks?
This whole messy case should find its way into court, at least one hopes it does. It certainly works under basic product liability/failure to warn theory. I don’t fancy Olympus’ chances of successfully defending such suits either, given that they knew there might be a problem and warned other customers. And, for the families of the deceased patients, a wrongful death suit may stand.
Perhaps it’s an issue of standards? One dips into speculation now, but maybe Olympus thought they’d lose business if the truth were known in the U.S.? That doesn’t speak very highly of European standards, though. Maybe it’s because the FDA didn’t seem to be too concerned with the issue? Illogical, given that its purpose is to protect citizens from suspected dangers and the agency had every reason to suspect a risk of danger based on Olympus’ actions in Europe. The FDA would never dream of risking American lives, right?
It’ll all (hopefully) come out in court soon enough. How does one say “my bad” in French?
Never mind, Olympus, just break out the checkbook.