One of the hottest new trends in health care includes surgical procedures conducted by robots, including those made by Intuitive Surgical Inc. (ISRG), such as its "da Vinci Surgical System." Recently, the U.S. Food & Drug Administration--responsible for overseeing the safety and efficacy of prescription drugs and medical devices--has decided to look into whether these techno-surgeons are safe.
Specifically, the FDA has requested that surgeons at particular hospitals across the country list the complications they have experienced or seen with the technology. According to reports, such surgeries cause about $1.5 million each and were used in nearly 500,000 procedures last year.
The FDA submitted a surgery to the surgeons also asking which surgeries the robots might be best at or worst at to perform. Apparently, the FDA is interested in whether there a rise in incidents may be due to problems with the machines. At this point, regulators have not pinpointed a specific cause of the rise in surgical incidents. Additionally, the results of the investigation will help answer the basic question of whether robotic surgeries (which are marketed as being less invasive) are worth their costs.
The incident reports may be adverse event reports (AERs) submitted to the FDA by doctors, patients or the robot-makers themselves. AERs involving the machines include gynecological surgeries that represent about half of the procedures using Intuitive's robotic machines. The AERs include damage such as when the instruments broke off and fell into patients. They also include instances of user errors and not with the machines themselves.
Intuitive continues to publically state that its products are extremely safe, and that the benefit of the technology far outweighs the risks and costs.