Better training needed for surgeons using da Vinci robots?

There is an interesting article on the Bloomberg web site today addressing the appropriate training of surgeons prior to unsupervised use of Intuitive Surgical’s da Vinci robot.

It is easy to point fingers at all parties regarding the complications and more severe problems associated with robot-assisted surgery using the da Vinci system (including the 70 documented deaths). There have clearly been some technical problems with the robot itself, but it is also apparent that many surgeons have not received sufficient training on the system before being allowed to do unsupervised procedures.

In the article on the Bloomberg web site, a spokesperson for Intuitive is quoted as stating that

added training is available for surgeons who request it “in many forms — from the manufacturer, from their hospital and from surgical societies.

However, a reaction to that statement from Prof. Erik Gordon, of the Ross School of Business at the University of Michigan in Ann Arbor, is also worth quoting. Said Prof. Gordon,

We don’t let inadequately trained people fly airplanes and excuse it by saying that added training is available for pilots who request it.

The “New” Prostate Cancer InfoLink is of the opinion that both Intuitive Surgical and many hospitals failed in their social obligation to ensure that surgeons were appropriately and fully trained prior to being allowed to carry out unsupervised procedures on patients who were being (inappropriately) led to believe that “robotic” surgery was in some significant way “better” or “safer” than other surgical procedures. This was not by any means limited to radical prostatectomies. The da Vinci robot has been adopted for use in a wide variety of invasive surgical procedures from hysterectomies and radical prostatectomies to repairing torn heart valves.

According to the U.S. Food and Drug Administration, in a statement last week, during 2013 the agency has

received 3,697 adverse event reports through Nov. 3, compared with 1,595 through all of 2012.

However, William Maisel, the chief scientist for the FDA’s Center for Devices and Radiological Health, also was careful to note that while

We identified issues that warranted additional investigation, and that prompted us to go out to the company and inspect them, … No one should be concluding simply from the increase in adverse event reports that there is a problem with the device and [that] it should not be used.

6 Responses

  1. When I was diagnosed with prostate cancer almost 6 years ago, my urologist strongly suggested having prostatectomy via the da Vinci system. He said that the risk of complications were much better and my recovery would be much quicker. I still remember the ads on TV showing the fellow playing golf right after surgery using the da Vinci system. What a bunch of bull. I had major complications that could have been compounded by an inexperienced surgeon. I was his 10th da Vinci procedure. I had a lot of confidence in my doctor and trusted him. Now, we learn that the outcome of the da Vinci procedure is not any better; or possibly even worse than an open surgical procedure. I am one angry person who now must live with all of the complications. Sad that the marketing hype and inexperienced surgeons have created irreversible damage or even death to so many.

  2. While I cannot lay my hand on the reference, I believe there is a study/report that suggests patients should look for surgeons who have completed at least 1,500 procedures!

  3. There was a poster presented a couple of years ago (I think at the Genitourinary Cancer Symposium) that did indeed suggest that the three surgeons in the study who had completed 1,500 or more procedures had the highest skill levels. What I do not think was necessarily proven in this study was whether that made them the “best” surgeons from a patient perspective. Surgeons who do three or more procedures a day do not necessarily have the same level of ability to discuss their findings in detail with patients post-operatively. Why? Because if you do three or more procedures a day, the details of each operation tend to start “blending” into one another — and that is not helpful from a patient communication perspective.

    Ideally, the wise patient is looking for a surgeon who has done enough procedures to be “really good” as a surgical technician but who is also sufficiently focused on exactly what he/she did during any one procedure to be able to recount important details to individual patients. That requires thoughtful communication skills in addition to technical surgical expertise. Doin a lot of operations is not the only criterion of measurement for skill. It is what you do with that accumulated experience that is important! Every really good surgeon will tell you that s/he continues to learn from every procedure that s/he does, so yes, the more you do the better, but the better you do them the better too!

  4. Not sure I understand why Medicare and private insurance pay for da Vinci RP when it produces no better results than open RP. How does this help bend the healthcare cost curve?

  5. The statistic of adverse events over time provides little useful information. Rather than there having been changes at Intuitive Surgical, It probably reflects increased use and possibly more surgeons rushing into using the devices.

    The FDA would be better advised to investigate the training standards of hospitals and professional accrediting organizations.

    Only in emergency situations should patients be subjected to any sort of operations by surgeons who have not had very thorough training on artificial and animal models, extensive supervised experience, and lengthy and frequent performance of the specific procedure. There are many ways for entering surgeons to train, and there are good reasons for specialization.

    That is what I considered, when I chose a urologist who had already done 600 RALPs.

  6. David C:

    Honest question … Why on earth would you pick a guy who had done 9 surgeries? I picked a guy who had done 5,000 and have no complications at all.

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