The use of robotic surgical systems is expanding rapidly, but hospitals, patients and regulators may not be getting enough information to determine whether the high tech approach is worth its cost.
Problems resulting from surgery using robotic equipment—including deaths—have been reported late, inaccurately or not at all to the Food and Drug Administration, according to one study.
Dr. Martin A. Makary, an associate professor of surgery and health policy and management at John Hopkins University and one of the study’s authors, said that, while the future for robotic surgery is promising, there is a gray area when it comes to assessing the difference between doctor and device error. And benefits from the use of the device may be inconsistent, he said.
Makary and his co-authors noted an earlier finding that “among the 37 percent of U.S. hospitals that describe robotic surgery on their hospital website, none mentioned any potential risks or complications.
“We rely on a haphazard reporting system that uses immature data and only the best experiences make it into the data,” Makary said. “We introduce things but we don’t evaluate them very well. If we’re relying on the FDA about what (products) are superior, then we need a new process...you can’t make conclusions on the safety profile of a device based on a shoddy reporting system.”
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