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According to researchers at Johns Hopkins University, even though usage of surgical robots in hospitals has increased dramatically over the past 10 years, a disorganized system for reporting surgical errors makes the robot’s safety information inaccurate.
Robot-assisted surgery is a minimally invasive technique used in a variety of operations, ranging from a hysterectomy to gallbladder removal. Some surgeons have complained that surgical robots reduce tactile sensations, making it difficult to be certain they are making appropriate incisions.
In a report for the Journal for Healthcare Quality, researchers revealed that of the 1 million or so robotic surgeries performed since 2000, only 245 surgical errors (including 71 deaths) were reported to the U.S. Food and Drug Administration (FDA). When a surgical error occurs, hospitals are required to report the incident to the manufacturer, which in turn is required to report them to the FDA; however, research shows that this does not always happen.
The researchers found several incidents reported in the national media were not reported to the FDA until after the stories already appeared in the press, even though the incidents took place long before the news exposure. Researchers say that it is likely many other incidents go unreported, leaving the FDA in the dark.
“Doctors and patients can’t properly evaluate safety when we have a haphazard system of collecting data that is not independent and not transparent,” stated Martin A. Makary, M.D., M.P.H., the associate professor of surgery at the Johns Hopkins University School of Medicine.
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Koonz, McKenney, Johnson & DePaolis L.L.P.
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