Artificial intelligence has taken the medical device industry by storm — even adding a layer of complexity to the operating room that’s resulting in patients being hurt, some health professionals claim.
As Reuters reports, the TruDi Navigation System by device maker Acclarent was designed to treat chronic sinusitis, inflammation of the nasal sinuses, by inserting a tiny balloon to enlarge the sinus cavity openings.
But ever since the company added AI to the device, the US Food and Drug Administration has received at least unconfirmed 100 reports of malfunctions and adverse events, including at least ten instances of patients being injured.
While it’s still unclear what role AI played in these instances, the resulting injuries can be grim, from the punctured base of a patient’s skull to cerebrospinal fluid leaking from one another’s nose, per the reports.
Two victims who say they’ve experienced strokes following their sinuplasties involving the TruDi Navigation System have since sued the device’s maker, Acclarent, which has since been acquired by Integra LifeSciences. The plaintiff in one of the cases, Erin Ralph, accused the company of having the device mislead surgeon Marc Dean during a 2022 procedure, causing him to injure a carotid artery, leading to a blood clot and eventually a stroke.
The AI is used in the TruDi Navigation System to confirm the position of the devices inside the patient’s head.
“The product was arguably safer before integrating changes in the software to incorporate artificial intelligence than after the software modifications were implemented,” one of these suits alleges, as quoted by Reuters.
The second lawsuit was filed by Donna Fernihough, whose carotid artery allegedly “blew,” causing blood to spray “all over,” and resulting in her experiencing a stroke the same day.
Acclarent “knew or should have known that the purported artificial intelligence caused or exacerbated the tendency of the integrated navigation system product to be inconsistent, inaccurate, and unreliable,” Fernihough’s case alleges.
The suit also accused Acclarent of lowering “its safety standards to rush the new technology to market” and setting “as a goal only 80 percent accuracy for some of this new technology before integrating it into the TruDi Navigation System.”
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