Today's post is shared from kaiserhealthnews.org.
The use of robotic surgical systems is expanding rapidly, but hospitals, patients and regulators may not be getting enough information to determine whether the high tech approach is worth its cost.
Problems resulting from surgery using robotic equipment—including deaths—have been reported late, inaccurately or not at all to the Food and Drug Administration, according to one study.
The FDA assesses and approves products based on reported device-related complications. If a medical device malfunctions, hospitals are required to report the incident to the manufacturer, which then reports it to the agency. The FDA, in turn, creates a report for its Manufacturer and User Facility Device Experience database.
The use of surgical robots has grown rapidly since it was first approved for laparoscopic surgery (a type of surgery that uses smaller incisions than in traditional surgery) by the FDA in 2000. Between 2007 and 2011 the number of da Vinci systems installed increased by 75 percent in the United...
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