Artificial intelligence has taken the medical device industry by storm \u2014 even adding a layer of complexity to the operating room that\u2019s resulting in patients being hurt, some health professionals claim.<\/p>\n
As Reuters reports<\/a>, 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.<\/p>\n 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.<\/p>\n While it\u2019s still unclear what role AI played in these instances, the resulting injuries can be grim, from the punctured base of a patient\u2019s skull to cerebrospinal fluid leaking from one another\u2019s nose, per the reports.<\/p>\n Two victims who say they\u2019ve experienced strokes following their sinuplasties involving the TruDi Navigation System have since sued the device\u2019s 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.<\/p>\n The AI is used in the TruDi Navigation System to confirm the position of the devices inside the patient\u2019s head.<\/p>\n \u201cThe product was arguably safer before integrating changes in the software to incorporate artificial intelligence than after the software modifications were implemented,\u201d one of these suits alleges, as quoted by Reuters.<\/p>\n The second lawsuit was filed by Donna Fernihough, whose carotid artery allegedly \u201cblew,\u201d causing blood to spray \u201call over,\u201d and resulting in her experiencing a stroke the same day.<\/p>\n Acclarent \u201cknew 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,\u201d Fernihough\u2019s case alleges.<\/p>\n The suit also accused Acclarent of lowering \u201cits safety standards to rush the new technology to market\u201d and setting \u201cas a goal only 80 percent accuracy for some of this new technology before integrating it into the TruDi Navigation System.\u201d<\/p>\n Integra LifeSciences pushed back, telling Reuters that \u201cthere is no credible evidence to show any causal connection between the TruDi Navigation System, AI technology, and any alleged injuries.\u201d Acclarent denied allegations in both suits, which are still ongoing.<\/p>\n Nonetheless, these instances illustrate how the operating room is quickly being overtaken by AI, a trend that started long before the advent of large language models (LLMs) like the ones powering ChatGPT. For instance, machine-learning algorithms have been used to screen for diseases like cancer in medical scans for decades<\/a>.<\/p>\n We\u2019ve already seen reports of AI-powered medical instruments falling victim to the known shortcomings of the tech. For instance, a recent study<\/a> found that two-thirds of more than 12,000 patients identified as having heart failure by an AI-enhanced stethoscope<\/a> didn\u2019t actually have heart failure.<\/p>\n We\u2019ve also seen LLM-based chatbots designed to give medical advice to real-world patients experience widespread hallucinations<\/a>. Experts also warn that doctors are losing the ability to identify cancer<\/a> in scans due to the reliance on AI-powered detectors.<\/p>\n Whether regulatory oversight is there to ensure patients don\u2019t get hurt by AI medical devices remains a subject of heated debate. Devices using AI don\u2019t even have to be used in clinical trials before being approved by the FDA. Instead, many device makers point to previously authorized devices before adding AI to them, according to Reuters.<\/p>\n Worse yet, the Trump administration\u2019s enormous cuts to the FDA\u2019s budget<\/a> have led to dozens of AI scientists being laid off or encouraged to leave, adding plenty of pressure to those who remain. <\/p>\n \u201cIf you don\u2019t have the resources, things are more likely to be missed,\u201d a former device reviewer told Reuters. <\/p>\n Meanwhile, the FDA has doubled down on the tech, outsourcing oversight duties to LLMs<\/a> to \u201cfuel innovation\u201d and accelerate drug approvals.<\/p>\n Most recently, administrator of the Centers for Medicare & Medicaid Services Mehmet \u201cDoctor Oz\u201d Oz gloated<\/a> over \u201crobots\u201d that can do anything from performing ultrasounds on pregnant women and \u201cwands\u201d that can determine \u201cwhether the child\u2019s OK or not.\u201d<\/p>\n \u201cAnd frankly, I don\u2019t have to see the image,\u201d he said. \u201cI just have to know if the image is good enough to tell me the child doesn\u2019t have a problem.\u201d<\/p>\n