FDA Probes Docs Over da Vinci Robot Problems
"Surgeons and patients around the world have found da Vinci surgery to be safe and effective minimally invasive treatment option for a range of complex conditions," Intuitive has stated. "In fact, roughly 3,000 peer-reviewed studies have been published demonstrating the clinical effectiveness of da Vinci surgery."
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The Massachusetts Board of Registration in Medicine issued an advisory to physicians last month after finding increasing complications in robot-assisted surgeries. The board outlined steps that should be used to properly use the robot, including proper quality, safety and credentialing measures.
"As with any new technology, care should be taken that protocols are in place to ensure appropriate patient selection, and the full explanation of risks and benefits for all surgical options," it adds. Board officials did not respond for interview requests.
A significant concern involves lack of adequate training of physicians in handling of the robot. "How does the procedure present itself? The robot plays a supporting role in that," Thomas Skorup, FACHE, VP for the ECRI Institute, a non-profit that researches safety, quality and cost-effectiveness of patient care, told me in a recent conversation about the issue.
"How many 'at bats' are these surgeons getting to keep up their proficiency level at the appropriate level?" Skorup asks, referring to training of physicians in the use of the robot. "The safety issue is a key," he says. "There's a strong correlation, in my mind, to the proficiency and training of physicians."
Joe Cantlupe is a senior editor with HealthLeaders Media Online.
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