As AI enters the operating room, reports arise of botched surgeries and misidentified body parts
Medical device makers have been rushing to add AI to their products. While proponents say the new technology will revolutionize medicine, regulators are receiving a rising number of claims of patient injuries.
In 2021, a unit of healthcare giant Johnson & Johnson announced “a leap forward”: It had added artificial intelligence to a medical device used to treat chronic sinusitis, an inflammation of the sinuses. Acclarent said the software for its TruDi Navigation System would now use a machine-learning algorithm to assist ear, nose and throat specialists in surgeries.
The device had already been on the market for about three years. Until then, the U.S. Food and Drug Administration had received unconfirmed reports of seven instances in which the device malfunctioned and another report of a patient injury. Since AI was added to the device, the FDA has received unconfirmed reports of at least 100 malfunctions and adverse events.
