|Olympus TJF-Q180V Duodenoscope--Courtesy of Olympus Australia|
The duodenoscope safety saga is growing ever more dramatic. The infected endoscopes for visualization of the bile and pancreatic duct have left dead patients in their wake, since at least 1987, it turns out. Are duodenoscopes this year's equivalent of power morcellators?
Attorney Peter Kaufman plans four to six additional lawsuits against duodenoscope manufacturer Olympus, including three wrongful death suits related to an outbreak of the antibiotic-resistant "superbug" known as CRE.
"These patients were exposed to the scope's cultured CRE, meaning they had tests done and the presence of the CRE was detected, and then they died," he said during an 89.3 KPCC broadcast out of California.
Kaufman is already suing Olympus for the death of one patient and the sickness of another. All of the incidents related to the actual or upcoming suits occurred at UCLA Medical Center, where at least 179 patients face possible exposure to CRE from two contaminated endoscopes, out of 7 used at that time.
Kaufman may sue UCLA too, according to the radio report.
The suit against Olympus says that the company failed to create a cleaning protocol for its redesigned Q180V Scope. The redesign occurred in 2014, but did not contain new cleaning instructions, the suit says, according to The Fresno Bee. It also alleges that the company knew about the problem in 2013, when it was informed of the deaths of four patients in Washington.
Outbreaks of CRE linked to endoscopes have also occurred in Philadelphia and Minnesota. The latter case occurred in 1987, CNN reports, raising the obvious question as to why the FDA didn't take action sooner. The article states the FDA believes it did not have "convincing evidence" of the link between duodenoscopes and CRE until 2013.
Now, the FDA is entering the fray. It just issued a safety warning saying, "Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it."
The traditional cleaning method involves brushing, rinsing and treating the scope with chemicals. But some hospitals are now using gas sterilization, including Virginia Mason Medical Center in Seattle (another affected hospital), at a cost of about $1 million.
Physicians' associations are also offering their opinion on the controversy. The American Gastroenterological Association is concerned about the development and is holding a workshop on effective scope cleaning on March 21. But it reaffirmed the benefits of ERCP, or the type of surgery that involves the use of duodenoscopes.
"The therapeutic benefits of ERCP outweigh the potential low risk of infection. The infectious complication rate for ERCP overall is in total only about 1 percent. That includes all types of bacteria and these CRE cases do not change the overall risk," it said in a Feb. 20 statement.
In addition, the Association for Professionals in Infection Control and Epidemiology released a list of key points and technical guidelines for practitioners.
Centers for Disease Control and Prevention director Thomas Friedan foreshadowed the event with his constant warnings about the lack of new antibiotics, as well as the rise of drug resistant pathogens due to the over prescription of the medications.
Besides Olympus, Fujifilm Holdings Pentax Medical also make duodenoscopes.
Boston Scientific ($BSX) just launched the SpyGlass DS, which contains a catheter tip that attaches to duodenoscopes for enhanced visualization. The catheter is a single-use device, eliminating the need for preprocessing and cleaning.