Robotic surgery injuries lead to questions about FDA oversight
Many patients and physicians in New York are taking note of claims of injuries caused by robotic medical devices that are not being reported to the Food and Drug Administration. The incidents have led some to call for the FDA to revise its protocol for overseeing surgical procedures and the reporting of surgical errors.
Thousands of surgeries are performed each year using robotic surgical devices manufactured by companies like Intuitive Surgical Inc. Some patients who have undergone surgical procedures performed by these robotic medical devices have reported adverse outcomes such as severe burns, nerve damage and punctured organs. Although training on robotic surgical devices is available from the companies that manufacture them and from the hospitals where they are used, it is not very adequate adequate, letting doctors perform any procedure they want after just a few expert-supervised surgeries, according to the head of the surgery department at the University of Illinois at Chicago.
Bloomberg recently conducted a review of surgical outcomes for procedures performed using Intuitive Surgical's robotic medical devices. It found that several incidents of adverse patient outcomes went unreported. Although hospitals are required to report surgical errors to the FDA, under the current system, many surgical injuries and errors are reported years after they occur or not at all. To address these concerns, the FDA is working on several improvements to the current system such as assigning unique identifiers to help the tracking of medical devices and developing more comprehensive medical device registries to track outcomes and expedite the identification of potential problems.
Those recovering from adverse outcomes resulting from a surgical error may feel unsure of what steps they should take to seek compensation for their injuries. A consultation with an attorney working in the area of medical malpractice could help to provide a clearer picture of the legal options available.
Source: Bloomberg, "Unreported Robot Surgery Injuries Open Questions for FDA", Robert Langerth, December 29, 2013