FDA investigating the safety of surgical robots

Apr 18 2013

With more than 4,500 robotic prostate surgeries under his belt, David Samadi , MD may be the last person you'd expect to welcome an FDA investigation of robotic surgery. But late Tuesday he appeared on Fox 5 News saying, "Let the FDA do their investigation and clear the air. This is about our prostate cancer patients."

Dr. David Samadi is Vice Chairman of the Department of Urology and Chief of Robotics and Minimally Invasive Surgery at Mount Sinai Medical Center. He was among the first in the world to perform robotic prostate surgery and today he uses the da Vinici robot in his highly successful SMART (Samadi Modified Advanced Robotic Technique) version of the procedure.

Dr. Samadi offers these key questions for patients to ask their prospective surgeon:

1. How many successful robotic surgeries have you performed?
2. Will I be your only patient/operating room during my procedure?
3. What are the typical complications following your robotic surgeries?

Over the past few years, hospitals have invested big money in procuring and promoting surgical robots, but enthusiasm for the technology may be waning amid reports of robotic surgery mistakes and deaths. In 2012, the nationwide count for robotic surgeries hit almost 400,000. Some experts say more robotic procedures are bound to result in increased data on negative surgical outcomes. But is it really a matter of odds or just an excuse for surgeon inexperience and limited training requirements?

Dr. Samadi stands by the robot, instead directing patient focus to the surgeon and the hospital. Stressing the surgeon-robot duo he says, "The technology is safe; you have to know how to use it."

Dr. Samadi believes the robot may be little more than a scapegoat for robotic surgery complications that might otherwise be prevented with more stringent hospital credentialing of robotic surgeons. A 2010 study, published in The New England Journal of Medicine, suggested surgeons need to perform only 150 robotic procedures to become adept, http://www.nejm.org/doi/full/10.1056/NEJMp1006602

While it may be easier to take aim at technology, surgery is still surgery and, "The robot doesn't do the surgery by itself," Dr. Samadi states.