FDA wants input from surgeons regarding robotic surgery devices

Chicago patients may understand that surgery comes with risks, but patients also understand that certain types of risks can be avoided. A patient should never suffer injuries because a doctor performed the wrong surgery or surgery on the wrong body part. And a patient should never suffer disabling or life-threatening injuries if complications do arise because doctors were not paying attention to a patient’s condition while under the knife or while recovering from an operation.

These types of surgical errors are errors that are completely avoidable. However, doctors are human, and sometimes negligence gets in the way of providing patients with the type of medical care that they need and deserve. In an effort to take human error out of the equation when it comes to surgery, some companies have developed robots that are designed to perform surgical procedures on human patients. The question is: Are these devices safe?

Last year, robots sold by Intuitive Surgical Inc. were used for nearly half a million operations. Although some claim the medical devices are safe, the U.S. Food and Drug Administration is not so sure. The FDA recently reported that it has received a number of concerning complaints about the products from patients, medical professionals and healthcare companies. In an effort to better understand the safety and effectiveness of Intuitive Surgical’s robotic devices, the FDA is asking surgeons across the U.S. to take part in a survey regarding the devices and robotic surgeries.

The robots do not perform operations completely on their own. Doctors sit at a console that allows them to maneuver the robots during operations while watching a high-definition display that shows surgeons what is going on. While these types of procedures have been performed, though, some patients have suffered serious injuries. The FDA hopes to get a better understanding of why these injuries and adverse events are occurring. The survey asks surgeons to describe any complications they have experienced while using the robots during surgery and whether surgeons think they are receiving sufficient training to perform surgeries correctly and safely with robotic devices.

Source: Bloomberg News, “Surgical robots probed by U.S. in surgeon survey,” Robert Langreth, Feb. 28, 2013

Medical Devices


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