The introduction of AI to the operating theater doesn’t always work out as expected. Reuters has published a detailed report, with examples taken from lawsuits involving three ‘AI-enhanced’ medical machines. In the most excruciating example of an AI-assisted medical device going wrong, the ‘enhanced’ system is blamed for causing major medical emergencies, resulting in blood spraying around the operating room, and causing victims to suffer strokes.
Before we go into detail, it must be noted that the FDA reports seen by Reuters aren’t complete, so don't definitively indicate the introduction of AI was the root cause behind the increase in mishaps. However, lawsuits are pushing the argument that AI contributed to the injuries that occurred since the medical machinery ‘enhancements’ arrived.
It was also noted by Reuters that FDA-authorized medical AI devices have seen twice the recall rate compared to the baseline. Meanwhile, the FDA is struggling to keep pace with the AI-enhanced medical devices headed to market. Sadly, the FDA has been affected by cuts under the DOGE initiative. Here, specifically, 15 out of 40 AI scientists in the Division of Imaging, Diagnostics and Software Reliability (DIDSR) have been laid off or left, say insiders.
TruDi Navigation System from Acclarent
TruDi from Acclarent is used by clinicians to treat chronic sinusitis. It is designed to simplify surgical planning and provide real-time feedback during delicate procedures such as sinus operations.
After three years on the market, and a reported eight malfunctions, the device was ‘enhanced’ by AI algorithms and has since been involved in “at least 100 malfunctions and adverse events,” notes the Reuters report.
Problems attributed to TruDi AI have included cerebrospinal fluid leaks, puncture of the base of the skull, major arterial damage, and strokes.
Two specific (horrific) cases are detailed in the source story. The first involves Erin Ralph. This victim is currently taking legal action, and their lawsuit alleges that the TruDi system misdirected the doctor to put surgical instruments near the carotid artery. This caused a blood clot incident and stroke, it is claimed.
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Ralph subsequently needed five days in intensive care, experienced brain swelling, and a portion of skull needed to be removed as part of the remedial treatment. One year later, Ralph is still in physical therapy due to ongoing physical issues.
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