Robotic surgery: revisiting “no innovation without evaluation”

Far from being restricted to the realm of science fiction, robots are now used in many spheres—creating cars, taking inventories, and even cleaning homes (www.irobot.com).1 2 Robots have also become part of healthcare, particularly surgical procedures. Recent articles such as that in the New York Times, “When Robotic Surgery Leaves Just a Scratch,” reinforce this image.3 But what is the evidence to support the use of robotic technology in surgery?

The safety and effectiveness of surgical devices and corresponding outcomes after surgery have consistently come under scrutiny in the past two decades. Despite concerns over safety, effectiveness, and sometimes costs, new devices and technologies for surgery are constantly and uncontrollably developed. These new technologies are often rapidly adopted with minimal scientific evidence.4 The da Vinci robotic system made by Intuitive Surgical was approved by the United States Food and Drug Administration in 2000 under its much criticized 510(k) device provisions with minimal clinical evidence of safety or effectiveness. The FDA has recognized the need for reform of device regulation and recently announced its new postmarket surveillance vision.5 6 The FDA’s strategy provides a clear but high level view on how to identify problems with devices in the “real world.” The proposal relies on physicians, hospitals, patients, and device manufacturers …