FDA surveys surgeons over safety of surgical robots

Thursday February 28, 2013

In the last several years, there have been huge technological advances in the medical world. While they are all meant to better medical care and research, it’s important that they be thoroughly tested to ensure that they are safe for use on patients. To this end, our readers may be interested in a current probe by the federal Food and Drug Administration into Intuitive Surgical Inc.’s surgical robots.

For those who are not familiar with surgical robots, they were first developed for use during war but have since made their way into operating rooms across the country. Physicians operate the robot like a video game, sitting behind a screen that shows a 3-D display of the patient’s body and using various controls to direct the machine’s arms to perform the surgery. Recently, however, the FDA has noticed a spike in adverse event reports, which could lead to medical malpractice.

The FDA says it’s not clear right now why there has been an upswing in negative reports coming in, but the agency hopes to get to the bottom of things. They have asked surgeons who work with the machines to report any problems they’ve noticed when using the robots. The survey also includes questions about the surgeons’ training to work with the robots and which surgeries they are most effective for and least effective for.

Although the rise in adverse event reports could be related to the fact that the number of surgeries performed with robots has increased, it’s still important to make sure that they are safe for use on patients. It will be interesting to see what information the FDA’s survey yields.

Source: Bloomberg, “Intuitive Surgical Robot Safety Probed by Regulators,” Robert Langreth, Feb. 28, 2013

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