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FDA Probes Docs Over da Vinci Robot Problems

 |  By jcantlupe@healthleadersmedia.com  
   April 25, 2013

No medical device dominates the news as much as the multi-armed robot, particularly the da Vinci, which is at once fiercely loved and incredibly despised.

Some doctors tell me it's the greatest tool they've got to improve efficiencies in the operating room. Others say it's a disaster waiting to happen. In some instances, they believe it already has. While some hospitals are counting on the robot for higher ROI, a growing number of lawsuits is taking center stage over allegations of improper procedures.

In the meantime, the federal Food and Drug Administration has launched a survey to evaluate the robot, focusing on physicians' opinions about the device.

Indeed, the controversy isn't just about the mechanics of the device itself. Often, the robot problems are associated with physician training. Questions about training involving the manufacturer have been raised and there have been allegations of physicians mishandling the device.

The FDA acknowledges there have been increasing reports of adverse events related to the da Vinci, and agency officials want to talk to surgeons about the reasons behind the complaints. Are physicians to blame? Are the robots to blame?

Federal officials have begun a survey of physicians "after we observed an increase in the number of (adverse events) we received about the da Vinci surgical system," FDA spokeswoman Synim Rivers told me.

While the FDA isn't revealing numbers, Rivers emphasized that the "increases in reporting can be due to a number of factors, including an increase in the number of devices being used—as well as an increase in awareness of how to report device issues to the FDA."

To get a better sense of how to interpret the da Vinci reports, the FDA is surveying a "small sample of surgeons" who use the da Vinci system. "Since it is difficult to know why the reports have increased, FDA has elected to talk with surgeons to better understand the factors that may be contributing to the rise in report numbers," Rivers says.

The surveys are considered a "routine part of surveillance" and one of several postmarket tools that the FDA uses to help evaluate device performance and use and to "further understand the risk-benefit profile for devices."

"Increased publicity resulting from product recalls, media coverage, litigation, and other influences can also increase the number of reports, but this doesn't necessarily indicate a true rise in event occurrence," Rivers explains.

And because reports submitted to the FDA can contain "incomplete, inaccurate, duplicative, and unverified information, an upward trend of adverse event reports is not by itself directly indicative of a faulty or defective medical device," she says.

As part of the survey, the FDA is interested in questioning surgeons who use the da Vinci device for "a variety of procedures." The agency sent a letter to surgeons at hospitals that participate in the FDA's center for devices and radiological health's Medical Product Safety Network, known as MedSun.

In the letter, the FDA says it wants to "better understand users' perspectives on the different challenges raised when using the da Vinci surgical system interface for performing surgery versus conventional surgical procedures." Among the questions to surgeons:

  • How many surgeries and what types of surgeries have you performed using the da Vinci surgical system over the last three years?
  • What procedures do you believe are most suited, or least suited for the da Vinci;
  • Do you prefer the da Vinci system to conventional systems?
  • What are the "problems or challenges" of the da Vinci?
  • What "kind of complications" are you seeing?
  • How is training usually conducted and how often does it occur?

The FDA says the survey "is intended to help us better understand [users'] perspectives on the different challenges raised when using the da Vinci system interface for performing surgery versus using conventional surgical procedures." The survey also could assess current and future trends in the robotic surgery. The survey results would be "qualitative in nature, not quantitative."

For now, the FDA is holding back on its view about the da Vinci – or even how physicians are using the robot until it gets more facts.

But the agency shouldn't wait too long, since many patient outcomes and huge dollars are hanging in the balance.

The issue of physician training is spotlighted in a case that is playing out in Washington state, where a jury will decide whether Intuitive Surgical, the maker of da Vinci, properly trained a physician who, in his first unassisted surgery using the company's da Vinci surgical system, removed the prostate gland of a patient who later died, according to Bloomberg News.

"Surgeons and patients around the world have found da Vinci surgery to be safe and effective minimally invasive treatment option for a range of complex conditions," Intuitive has stated. "In fact, roughly 3,000 peer-reviewed studies have been published demonstrating the clinical effectiveness of da Vinci surgery."

The Massachusetts Board of Registration in Medicine issued an advisory to physicians last month after finding increasing complications in robot-assisted surgeries. The board outlined steps that should be used to properly use the robot, including proper quality, safety and credentialing measures.

"As with any new technology, care should be taken that protocols are in place to ensure appropriate patient selection, and the full explanation of risks and benefits for all surgical options," it adds. Board officials did not respond for interview requests.

A significant concern involves lack of adequate training of physicians in handling of the robot. "How does the procedure present itself? The robot plays a supporting role in that," Thomas Skorup, FACHE, VP for the ECRI Institute, a non-profit that researches safety, quality and cost-effectiveness of patient care, told me in a recent conversation about the issue.

"How many 'at bats' are these surgeons getting to keep up their proficiency level at the appropriate level?" Skorup asks, referring to training of physicians in the use of the robot. "The safety issue is a key," he says. "There's a strong correlation, in my mind, to the proficiency and training of physicians."

Joe Cantlupe is a senior editor with HealthLeaders Media Online.
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