Robotic surgical systems maker Intuitive Surgical (NSDQ:ISRG) is once again getting some unwanted attention after a team of California researchers used the technology as a prime example of the dangers of novel devices.
In a study published this month in the Journal of the American Medical Assn. researchers warned that rapid adoption of new surgical devices may put patients in danger as doctors navigate a sometimes steep learning curve. Although the study focused on Intuitive Surgical’s da Vinci robot, the authors took care to emphasize that the problem is not with the technology itself, but is a systemic issue that highlights the need for thorough training and cautious adoption of new devices.
Intuitive Surgical took issue with the study results, calling the researchers’ methods "incomplete and inaccurate," but the authors have maintained that the limitations of their study don’t change the bottom line.
"This study looked at the stages of innovation and how the rapid adoption of a new surgical technology – in this case, a surgical robotic system – can lead to adverse events for patients," lead author and UC San Diego Health System surgical oncologist Dr. Kellogg Parsons said in prepared remarks. "There is a real need for standardized training programs, rules governing surgeon competence and credentialing, and guidelines for hospital privileging when novel technologies reach the operating rooms of teaching and community hospitals."
Intuitive Surgical won FDA approval for the da Vinci system, and the technology took a few years to gain a foothold. U.S. adoption of the technology skyrocketed from 620 minimally invasive robotic prostatectomies in 2003 to more than 37,700 in 2009.
The authors examined more than 400,000 prostatectomy patients reported in the Nationwide Inpatient Sample from January 1, 2003 through December 31, 2009, the vast majority of which underwent traditional surgery. Over the course of the entire study both groups experienced similar rates of complications (about 1% to 2%), but prostatectomy risk rates nearly doubled in 2006, a peak year for adoption of the da Vinci system. That year about 1 out of every 10 prostatectomies was conducted with robotic assistance, researchers said.
Intuitive Surgical criticized the study, saying that researchers weren’t able to properly distinguish complications associated with radical prostatectomy from robot-assisted prostatectomy. The company has published a raft of studies of its own that show that the device is safe and effective.
"Independent, peer-reviewed studies that use appropriate methodology and databases come to conclusions similar to ours regarding both safety and diffusion of robotic-assisted prostatectomy," Intuitive scientific affairs senior vice president Dave Rosa told MassDevice.com via email. "The procedure codes required to identify minimally invasive prostatectomies are not available prior to Oct. 1, 2008 in the NIS database used by the authors."
The study authors maintained that Intuitive’s rebuttal doesn’t affect their conclusion, adding that the research is unique in combining data from hundreds of thousands of cases, Reuters reported.
Covidien (NYSE:COV) chief medical officer Mike Tarnoff offered his perspective on the study, noting that the so-called "learning curve phenomenon" is a fact of new technology, and not just in healthcare.
"I would apply it to any new technology, period. I’d apply it to a new airplane, I’d apply it to a new car, and it certainly applies to new health care,"Tarnoff told MassDevice.com. "Any casual observer can say the 1st time you use something or the 1st time you do something, you’re probably not going to be as skilled at it as the hundredth time you do it. The difference between the 1st time and the hundredth time is experience, and the question then becomes how do you provide appropriate experience to someone that’s only done it once as if they’d done it a hundred times?"
"Any time there’s a new approach, a new technique, a new technology, there’s going to be a learning curve associated with it. Patients that are within that learning curve are going to be at risk,"he added. "I think most people probably accept that that’s true. My point in all of this is to say that I don’t think that has to be true."
Tarnoff also warned against a "one-size-fits-all" model of training that assigns a rigid regiment to help physicians get acquainted with a new technology. Based on existing skill-sets and past experiences, one surgeon may need 5 cases to gain expertise where another may need 20. It’s also important that surgeons get time with a trainer who is a skilled teacher as well as an expert in the procedure in question.
"The industry as a whole could be looked at and on the one hand said to have put the reasonable amount of investment into training that was necessary to make it happen, but maybe not the right amount of thought," he added. "The dollars have always been there for physician training on new technology, but the thought in terms of how to use those dollars and how to execute that training really hasn’t always been there. That’s what creates this dynamic where this learning curve phenomenon exists."