Duodenoscopes, a tool used in the treatment of gallstones, cancer, and other disorders of the digestive system, are currently under scrutiny for their ability to spread infectious disease among patients. Because the tool cannot be properly sterilized, bacteria is spread from patient to patient during use – a fact that was not addressed in a timely manner by the FDA, device manufacturers, or the hospitals using them.
Virginia Mason Medical Center Joins Bigler Family in Lawsuit Against Duodenoscope Manufacturer
In one case currently under investigation, a Seattle hospital plans to join with the family of a deceased patient to take legal action against Olympus Corp. Olympus Corp. is the primary manufacturer of duodenoscopes for hospitals in the United States.
Theresa Bigler took legal action against both Virginia Mason Medical Center and Olympus after the death of her husband, following a duodenoscope procedure in 2013. Bigler claims his death was directly the result of exposure to infection on a contaminated scope. Bigler's attorney stated to the L.A. Times, “It's not very common to get a healthcare provider to join with a patient who sued them. It's a big deal because they obviously have a lot more knowledge about the product and how it should be used and cleaned.”
The hospital, as well as others that use the devices, claim they are doing everything they can to sterilize the tools, but dangerous debris remains present. The hospital claims it followed Olympus' instructions for cleaning the duodenoscopes, but still had a superbug outbreak that affected 39 patients over the course of two years beginning in 2012. The hospital filed its suit after action was taken by the Bigler family claiming the hospital was responsible.
Virginia Mason is still named as a defendant in the case, but is working with the Bigler family. Olympus Corp. is accused of being aware of the problem, but failing to issue an alert, a move the plaintiff's call “unethical and irresponsible.”
Ongoing Concerns about the Safety of Duodenoscopes Triggers Warning in the Netherlands
The L.A. Times reported a similar superbug outbreak occurred in 2012 in the Netherlands. Olympus issued a safety alert to European hospitals in January 2013 and sent a second warning in Europe in August 2014 after receiving complaints of debris on the scopes despite sanitization. It wasn't until after The Times reported on seven infections at UCLA on February 2015 that Olympus bothered to issue a warning to US hospitals about the potential danger.