More and more industries are investing in and relying on artificial intelligence, including surgeons in the operating room. But when algorithms guide surgical tools, regulators receive an increase in safety reports and lawsuits, according to a Reuters investigation.
What happened?
Since 2021, U.S. regulators have received more than 1,401 reports involving devices on the FDA’s artificial intelligence list, according to court documents and Food and Drug Administration records. The accusations include botched surgeries and software that misidentified body parts.
For example, a sinus surgery device called the TruDi Navigation System was updated in 2021 to include artificial intelligence. According to the FDA adverse event report cited by Reuters, there were 7 failure reports before the addition of AI, and at least 100 failure and adverse event reports after the update. Two patients in Texas suffered strokes after their surgeons allegedly misinformed them about the location of surgical instruments near their carotid arteries.
“[Acclarent] The lawsuit alleges that the company knew or should have known that the so-called artificial intelligence caused or exacerbated a tendency for integrated navigation system products to be inconsistent, inaccurate and unreliable, Reuters reported.
Integra LifeSciences responded to Reuters for comment, saying there was “no credible evidence” linking AI technology to harm.
Why is artificial intelligence gaining attention in surgery?
Dr. Alexander Everhart, a lecturer at the University of Washington School of Medicine, said artificial intelligence medical devices could pose safety risks, especially since they do not require clinical trials on patients. These include a prenatal ultrasound tool called Sonio Detect, which allegedly misidentified fetal body parts, and a heart monitor made by Medtronic that allegedly failed to identify abnormal heart rhythms.
Everhart said the FDA’s “traditional” way of regulating devices is not effective in ensuring the safety of AI technology, especially for medical treatments. For example, a research letter published in JAMA Health Forum cited by Reuters found that AI medical devices were linked to 182 recalls, 43% of which occurred less than a year after authorization.
In addition to reported medical risks, the use of artificial intelligence is putting pressure on global energy systems. AI systems may require large amounts of electricity and water, raising energy demands and costs. At the same time, AI can help improve the integration and efficiency of clean energy through the optimization of smart grids, suggesting that this technology has both promise and risks.
What are artificial intelligence medical devices doing?
Reuters quoted a spokesperson for the U.S. Department of Health and Human Services as saying that patient safety remains a top priority and the agency will continue to learn more about artificial intelligence and digital health. The FDA has expanded its roster of artificial intelligence experts, even as former employees say staff cuts have increased workload.
As artificial intelligence becomes increasingly integrated into everyday products and across industries, it’s important for consumers to understand how these emerging technologies are being marketed. Educating yourself on greenwashing can help evaluate a business’s commitment.
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