Klein: What hospitals should take away from the da Vinci debate

The Daily Briefing's Hanna Jaquith spoke with Technology Insights' Rachel Klein to discuss the recent spike in lawsuits and complaints involving da Vinci surgical robots.

Q: The da Vinci robot has received some negative press in recent weeks. Why is the da Vinci making so many headlines?

Klein: One reason is the FDA's April announcement that it would investigate a 500-incident jump in da Vinci-related adverse events since January. Intuitive—the da Vinci's manufacturer—says it's because they changed how they report things.

To me, a 500-incident jump is more of a reporting change, rather than something that went wrong with the robot in four months. If the robot was malfunctioning in 500 cases, we would have heard about it.

Overall, I think the bad press is the result of overblown expectations by Intuitive and surgeons who said that patients would start to demand the robot. Meanwhile, studies are starting to find that the robot costs more and doesn't provide any clinical benefit above what a skilled surgeon can do.

Q: To boil it down, what's the difference between traditional surgery and surgery with the da Vinci?

Klein: The da Vinci system doesn't actually do surgery any differently—it's just a tool, like a scalpel. At the heart of the dozen or so lawsuits against Intuitive alleging complications from the da Vinci system is the idea that a robot is just a tool.

So, the question becomes: Is the vendor at fault for a malfunctioning robot, or was the complication a result of a relatively unskilled surgeon who shouldn't be doing the case anyway? I think that the court—and for that matter, FDA—is going to have a hard time determining who is at fault in these situations.

Q: In one of those lawsuits, a jury last month found in favor of Intuitive. The plaintiffs' attorneys argued that Intuitive should be held liable for recommending just two supervised surgeries and a one-day training seminar before a surgeon can use the da Vinci. Thoughts?

Klein: I think the plaintiffs' assertion that the surgeon had only done two cases prior to performing this surgery is important. However, that is all that's required by the FDA right now and until that changes, there isn’t much incentive for surgeons to ask for additional training.

Instead, many hospitals we work with through Technology Insights require higher levels of proctored cases—about five to 10.

The case also raises the idea of patient selection criteria, or who should have robotic surgery. Right now, there aren’t any standards on who should or should not receive the surgery—it's up to the surgeon's discretion. As a result of this case, I could see more hospitals encouraging their robotics committees to arrive at these standards to set some parameters on ideal cases so risk is minimized here.

Q: The plaintiffs' also argued that Intuitive tried to manipulate surgeons by placing sales reps in the OR. A recent New York Times article also criticized this practice. But putting sales reps in the OR isn't exactly new, is it?

Klein: That bothered me about the Times article; we shouldn't be too surprised that Intuitive wants more robotic surgery. However, pressure to increase use of robotic surgery comes from a number of places; the vendor is just one of them. Patients ask for it themselves, and some hospital administrators—who bought the $2 million robot primarily for prostatectomy—now are stuck with a $2 million doorstop. They're looking for other ways to use it.

Q: Overall, what should hospitals take away from recent events?

Klein: We've helped a lot of hospitals determine if the robot is right for them. For them, the question used to be, "Is this robot right for me, can I break even?" Now, there's pretty broad consensus that no, it's not profitable. For 95% of organizations, this is a money-losing investment. The questions have shifted to—"How can I better use the robot that I already have so that I don't have to buy another one. And how do I pick which surgeons should be using it?"


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