Editor's Note: A spike in the number of adverse event reports (AERs) associated with the da Vinci® Surgical System (Intuitive Surgical®, Sunnyvale, California) last year has prompted the US Food and Drug Administration (FDA) to survey surgeons about their experience with robot-assisted surgery. The number of AERs increased 34%, going from 211 in 2011 to 282 in 2012. During that period, the number of procedures performed with the da Vinci system in the United States increased 26%, going from 292,000 to 367,000. Medscape spoke to Joseph Colella, MD, Director of Robotic Surgery, Magee Women's Hospital, University of Pittsburgh Medical Center, and a founding member of the Clinical Robotic Surgery Association, about the FDA survey and the current state of robotic surgery in general.
Medscape: Do you think this FDA survey is warranted? And to what would you attribute the increase in AERs?
Joseph Colella, MD: When a new technology is being used and adopted in a relatively rapid fashion, oversight of that new technology needs to be very carefully employed. Learning-curve issues can arise, just as they did when we adopted laparoscopic technology.
AERs can be due to lack of training, to inappropriate use of this technology, or to the technology itself. In the case of AERs and robotic surgery, in the numbers that you quoted, there's a roughly proportional increase relative to the AERs and to the volume of cases done. It's not quite one to one, but it is relatively close.
One can also take into account the fact that as the technology is becoming more widely adopted, the individual hospitals that are using it have also matured relative to their ability to scrutinize events as they occur, report them, and then collect the data. As the hospital systems' ability to do these things developed, of course you are going to get more AERs. They are looking in places and for events that they were not looking in before. When I talk to other robotic surgeons, we seem to have a fair amount of unanimity that the increase in the numbers of these events is really due to the maturation of the oversight process among hospitals and individual hospital systems.
Medscape: Is this different from when laparoscopy was introduced?
Dr. Colella: The curves of adoption and adverse events that occur with robotics and that occurred with laparoscopic surgery are very similar, and I would go so far as to say they are almost identical. I should add that we're still learning today about complications and adverse events that occurred in laparoscopic surgery years after its widespread adoption.
Medscape General Surgery © 2013 WebMD, LLC
Cite this: Is Robotic Surgery Worth Its Price? An Interview With Dr. Joseph Colella - Medscape - Jun 20, 2013.