A Washington state jury has issued a critical ruling regarding Olympus and their duodenoscopes and found that the corporation’s much debated product design is not unsafe. However, the jury did order the corporation to pay $6.6 million for failing to provide proper warnings for its scopes, which have been found to have contributed to outbreaks of an antibiotic-resistant “superbug” across the country since 2010.
Despite the ordered payout, Olympus may view the jury’s ruling as a win. With the corporation now largely absolved of any faults in the design of this controversial product, hospitals and their reprocessing procedures will now bear most of the brunt of any investigations or scrutiny over future superbug outbreaks.
But the corporation’s troubling history with its scopes may still suggest the possibility of some future finding of fault, and it’s possible that the Olympus story is far from over.
As in the past, the scope in question is the TJF-Q180V, which was once again linked to an infection in an unsuspecting patient. Olympus had previously recalled the model in 2016 to replace defective parts. This, however, wasn’t the first time Olympus had to fix a flaw with its scopes. A redesign was deemed necessary in 2010 to “seal a narrow internal channel to keep out blood and other infectious material.”
Superbug outbreaks have persisted despite multiple attempts by the manufacturer to make its scopes safer. Medical device expert Lawrence Muscarella notes that determining the cause of such outbreaks can be extremely difficult, based largely on the fact that the product’s design appears to make full sterilization unlikely.
A recent study in the American Journal of Infection Control that examined 20 Olympus scopes only serves to further complicate the matter. Of the devices studied, 17 were returned to the corporation because of a defect. Another 12 were found to be contaminated with bacteria “even after being disinfected using the current guidelines or [considerable] additional measures,” leaving potential patients squarely in harm’s way.
Epidemiologist Cori Ofstead says that the compromised scopes violate consumers’ “right to assume that clean instruments are being used on them.” The potential danger only increases when considering that Olympus has a whopping 85% market share of the medical scopes in the United States.
To date, the FDA has shown to be more reactive than proactive when it comes to the matter of contaminated duodenoscopes, which are used in roughly 700,000 procedures annually and can be linked to at least 450 patient infections and 35 deaths. One would think those numbers alone would spur the agency to some sort of action. However, as of this writing, agency administrators seem content to acknowledge that “a broader approach to understanding how well duodenoscope devices work” is needed, without actually enacting a policy to make it happen.
In the meantime, the next outbreak sits poised and ready, waiting to show itself to an unsuspecting public.
