EXECUTIVE SUMMARY
Healthcare providers could face liability related to the recall of an Olympus duodenoscope. Failure to properly clean the device or report adverse events could create liability exposure.
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Facilities are unlikely to be involved in strict liability claims. Failure to report scope-related infections creates liability.
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The manufacturer updated its cleaning guidelines after safety concerns.
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Two pieces of legislation were introduced after an investigation found gaps in a law contributed to superbug outbreaks due to duodenoscopes.
Healthcare facilities and providers face potential liability related to the use of a scope that has been recalled and is the subject of lawsuits against the manufacturer.
Olympus Corp., manufacturer of about 85% of U.S. medical scopes, has announced a recall and redesign of its duodenoscope, which has been linked to deadly infections. The announcement came after a U.S. Senate committee report that found that the medical device manufacturer knew about a design flaw in the device for years without taking action.
Hospitals, surgery centers, and surgeons are unlikely to face strict liability related to the questionable scopes because they didn’t sell the scope to the patient, but, rather, provided a service using the scope, says Amy Alderfer, JD, an attorney with the law firm of Cozen O’Connor in Los Angeles. However, there could be liability if plaintiffs allege that the facility or provider didn’t follow the manufacturer’s cleaning guidelines, she says.
Olympus updated its cleaning guidelines once concerns were raised about the scope, so a hospital or surgery center could be held liable for not following the updated procedures, Alderfer says. “There were very rigorous requirements for how the scope had to be cleaned,” she says. “You want to see documentation that you were very strictly following those cleaning requirements so that you are not exposed to a negligence action by a plaintiff.”
Another potential area of exposure involves adverse event reporting and patient notification. The Senate committee report noted a lack of adverse event reports and patient notifications from hospitals. The widow of a Seattle area man who died after contracting a drug-resistant infection at Virginia Mason Medical Center in Seattle is suing the hospital and Olympus, and part of the case hinges on allegations that the hospital did not tell his family that the infection came from an Olympus duodenoscope. Virginia Mason recently began notifying patients and family members who were part of an outbreak that infected 32 people between 2012 and 2014. (For more information, see “New duodenoscope, recalls, and revised reprocessing instructions,” Same-Day Surgery, March 2016, at http://bit.ly/1roTlSv.)
Facilities and providers that used the recalled scope should assess their liability exposure by determining how well they followed the updated cleaning guidelines, whether they reported adverse events, and whether they properly notified patients involved with any scope-related infections, Alderfer suggests.
“This also is an important learning opportunity, even if you determine that you have little or no exposure related to this particular recall,” she says. “There are lessons here regarding the importance of following a manufacturer’s infection control guidelines and also the liability that can arise when you fail to notify patients promptly. Even when the injury is the result more of the device than the service the hospital provided, neglecting patient notification is one of the most likely ways you will be involved in messy litigation.”
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