An independent analysis of reports gathered by the U.S. Food and Drug Administration since 2000 shows that robotic surgery isn’t as safe as some people might assume.
Surgery involving robots, where a surgeon guides the steady and precise movements of a robotic arm, have increased dramatically in recent years. As reported in MIT Technology Review, patients underwent more than 1.7 million robotic procedures in the United States from 2007 to 2013. A new study by Jai Raman and colleagues at the Rush University Medical Center in Chicago shows these surgeries aren’t without risks.
By analyzing medical procedures involving robotic equipment and techniques, the researchers discovered that “adverse events” occur in about 550 out of 100,000 procedures (0.55%). An adverse event is defined as a complication that has a “significant negative impact for the patient.” What’s more, the researchers found that the number of deaths and injuries has increased 30 times since 2007, and that some forms of surgery are more risky than others. For instance, the mortality rate is almost 10 times higher for head, neck, and cardiothoracic surgery.
Technology Review provides a summary of the causes:
These include the equipment arcing or sparking during an operation, events that burned 193 patients between 2000 and 2013; in another category of incidents burned or broken pieces fell into the patient’s body, which occurred over 100 times and killed one patient; and another category involves uncontrolled movement of the instruments, which injured 52 patients and killed two of them. System errors such as the loss of video feed contributed to almost 800 other adverse events.
Curiously, although the database contains reports of 144 deaths during robotic surgery, the circumstances involved were recorded in detail in only a tiny fraction of cases. However, over 60 percent of these incidents were caused by device malfunctions while the rest were caused by factors such as operator error and the inherent risks of the surgery.
This all sounds pretty awful — and it is — but as noted in the TR article, Raman et al. failed to discuss “how these injury and death rates compare to procedures that take place without robotic techniques.” Indeed, it’s hard to put these figures into context without knowing how they compare to similar surgeries involving human surgeons. That said, a study from 2013 concluded that robots aren’t better at performing surgery, they just cost more.
At the very least, this study shows there’s considerable room for improvement.
Read the entire study at the pre-print arXiv: “Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data”. An earlier version of this work was presented at the 50th Annual Meeting of the Society of Thoracic Surgeons in January 2015.