Infection Lawsuit Compels Equipment Recall

Infection Lawsuit Compels Equipment Recall

Lawsuits change behavior and big lawsuits can make big changes.” So said an attorney for plaintiffs who sued Olympus Corporation and Virginia Mason Medical Center (VMMC) for failing to provide adequate cleaning and sterilization instructions for its duodenoscope. Surgeons at VMMC used a contaminated Olympus duodenoscope during an August 2013 surgery on 57-year-old Richard Bigler, who was suffering from pancreatic cancer, and who contracted an infection from the device and subsequently died.

The Jury Blamed Olympus and the Hospital

In its verdict, the jury stated that both VMMC and Olympus were liable for the death.

Olympus

The evidence proved that the manufacturer knew as early as 2012 that the device’s potential flaws could result in infection transmissions, but did nothing to alert either hospitals or regulators about the threat.

The jury also held the manufacturer responsible because of its sufficiently detailed cleaning instructions, which did not show how to prevent bacteria from being trapped in the device. Designed to be reusable, the device is expected to be completely cleaned and sterilized between uses to prevent the spread of any infectious bacteria. Despite the finding, the duodenoscope design was not declared defective, even though it may have contributed to the deaths of 35 people between 2013 and 2017. All of those patients had had surgery using the same model of TJF-Q180V Olympus duodenoscope used in Bigler’s case, and in 2016, Olympus recalled all 4,400 of those devices.

VMMC

The hospital was culpable because it failed to apply adequate sterilization standards when handling the reusable device. Doctors thread the duodenoscope down the patient’s throat to detect gastrointestinal anomalies, which means it is in frequent contact with potentially infected tissue. The hospital argued that it couldn’t clean the equipment properly because Olympus hadn’t provided appropriate instructions on how to do so.

What Hospitals Can Learn from the Olympus Case

The Olympus case demonstrates that maintaining rigorous sterilization and disinfection techniques is critical to avoiding liability for medical equipment-related infection outbreaks. Regardless of the sufficiency (or failure) of the manufacturer’s recommended sterilization procedures, it remains the obligation of every medical center to ensure that its infection control procedures are current, accurate, and well-documented. The services and testimony of a highly-trained Infection Control Professional can help other hospitals to avoid the big lawsuits such as the one in the Bi

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