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Training and Credentialing Standards Proposed for Surgeons Offering Robotic Surgery

Posted Oct 05 2009 10:02pm

Have you ever noticed billboards on your way to working placed by local hospitals bragging about their newly purchased robotic surgery device, da Vinci? I'll bet that the advertisement did not bother to mention that some of the surgeons operating in that hospital may not be qualified to use this expensive piece of equipment. Read on for an excerpt from a recent article on this topic (see: Medical societies push standards for robotic surgery ):

Surgeons are increasingly turning to high-tech robotic equipment to operate on patients with prostate cancer and other conditions but some medical authorities worry about inadequate training and lax standards among practitioners. Doctors are opting for Intuitive Surgical's popular da Vinci Surgical System over conventional surgery, especially for removing the prostate gland, because it is less invasive and allows for greater precision. There were some 80,000 robotic prostatectomy procedures in the United States last year....The rate of failure for such surgeries is comparable to that of traditional surgeries but patients are more at risk if inexperienced surgeons use the robots.... [A]n article in the September issue of the Journal of Urology...proposed instituting training standards for surgeons using the equipment. Currently, there is no credentialing system to evaluate a surgeon's competency and surgeons cannot practice on simulators before taking on live patients....[The author of the article], who said he has performed more than 500 robot-assisted surgeries, reckoned a surgeon must use the system at least 20 times before becoming familiar enough with the set-up and the procedure to do the surgery safely.... [He] said that surgeons, not manufacturers, carry ultimate responsibility for proper training. Ben Gong, vice president of finance at Intuitive, agreed, saying that while the company is committed to training, it is not the manufacturer's responsibility to set standards.

My understanding of the da Vinci robotic surgery system is that it is certainly radically different than normal surgery and even from laparoscopic (minimally invasive) surgery. So now we are faced with a situation where "some 80,000 robotic prostatectomy procedures in the United States last year" and urological societies are only now considering whether to require some sort of formal training standards and credentialing for the equipment. How much damage may have already been done to patients by urologists who are inadequately trained on the equipment? Think of the hue and cry that would ensure if even a handful of patients were harmed by a new drug on the market, even after rigorous clinical trials. As most of the readers of this blog will understand, surgical techniques and instruments are not subjected to the same scrutiny as drugs when they first come on the market. It seems to me that "using" the da Vinci device only "20 times," as suggested above, would constitute only a minimal demonstration of competence, given that the term "using" can be broadly interpreted. But let's not quibble. It's time for some long-overdue consideration of this problem of the introduction of new surgical equipment and devices. Let's pay more attention to patient safety and physician training and less to the marketing opportunities of some new piece of equipment.

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