Staying Ahead of the Learning Curve
Medscape: Another issue that is raised in regard to the use of robotic-assisted procedures is the learning curve. Because it is a newer type of technique, will we have to wait until we have 10, 20, or even 30 years of data to get to the point where we could obtain level-1 evidence? And does it mean that, at least for the time being, we should consider the idea of establishing centers of excellence for robotic-assisted surgery?
Dr. Parsons: Many experts have pointed out that there is no standardized process for credentialing, teaching, proctoring, or obtaining hospital privileges for robotic-assisted surgery. The learning process is very heterogeneous and very informal; there are continuing education courses and proctoring sessions that are sponsored by Intuitive Surgical, Inc. (manufacturer of the da Vinci® Surgical System), but there is no national standard by which an organization credentials surgeons to perform robotic surgery.
Clearly, we need a conversation about developing more structured processes for credentialing. But more specifically, we need to establish a process for determining how many procedures a surgeon needs to do before becoming proficient with a new surgical device like the robot. Simulator technologies enable us to assess qualitative proficiency, but we lack the tools for a quantitative assessment, and both are needed if we are to develop a uniform credentialing system. All of the stakeholders involved should take an active part in these discussions.
There has been discussion about regionalizing robotic surgery into centers of excellence, but it's not clear how something like that could be accomplished. Who gets to determine these centers of excellence? Who is going to pay for it? Who is going to address the logistical issues associated with getting patients who live 50 or 100 or 500 miles away and have very limited economic means to travel to that center of excellence for their surgery?
Both the Institute of Medicine and the US Food and Drug Administration (FDA) have recognized that the process by which new devices enter into practice needs to be revised, which you can see by the FDA's more aggressive postmarket surveillance stance now with the robot.[9,10] If we can become more thoughtful about the processes by which these new devices are brought into broader clinical practice beyond FDA approval as well as about the channels by which devices like the robot are marketed both to physicians and patients, I think there's a greater opportunity to improve the public health.
The robot is very promising technology which, like any other surgical tool, needs to be applied and studied in a thoughtful manner. In urologic surgery, I don't think randomized trials are feasible now simply because the technology is already in use. But we can learn from the way the robot entered into practice and improve this process in the future for the next surgical innovation that comes along. In the urology community, we've figured out that the robot can be applied appropriately in the cases of prostatectomy, cystectomy, and partial nephrectomy. Perhaps gynecologists are now looking to modify their own experience based on what they've seen happen in the field of urology.
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Cite this: Making the Most of Robotic-Assisted Surgery: An Interview With Dr. J. Kellogg Parsons - Medscape - Jul 15, 2013.