The rise of robotic surgery means that there has been a rise in complications related to robotic surgery, too: A new study links robotic surgery to nearly 150 patient deaths and almost 1,400 injuries between 2000 and 2013.
The study authors note that while the number of injuries and deaths per procedure has remained relatively constant, hospitals should implement safety improvements given the exponential rise in use of robotic surgery.
Robotic surgical systems, such as the da Vinci robot, make small incisions to conduct various surgical procedures, including removing ovaries and ovarian cysts. Supporters claim the robotic surgeries involve less blood loss than traditional minimally invasive surgery and have shorter recovery times and hospital stays.
However, others argue that regular laparoscopic surgery has the same benefits, without the high purchasing cost of robotic technology.
For the latest report, researchers from the Massachusetts Institute of Technology (MIT), Rush University Medical Center, and the University of Illinois at Urbana-Champaign looked at data from FDA's MAUDE database.
They studied more than 10,500 events related to robotic surgical instruments and systems over a 14-year period and found that 1,391 involved patient injuries, and 144 involved patient deaths. The remaining 8,061 events were device malfunctions. In all, the study found 550 reports of error per 100,000 robotic surgical procedures.
The researchers found that the rate of errors per surgery had remained largely constant since 2007. But because the use of robotic surgery has increased "exponentially," the number of adverse events increased every year, they wrote.
"Despite widespread adoption of robotic systems for minimally invasive surgery, a non-negligible number of technical difficulties and complications are still being experienced during procedures," the study authors said.
Some of the reported malfunctions and injuries include:
According to the researchers, many of the death reports included sparse details about how the individual died, so it is difficult to know whether the death came from a problem with the robot, human error, or standard surgical risks.
The study found that rates of death and injury were highest for cardiothoracic and head and neck surgery, likely because of procedures' complexity and because robotic devices are not frequently used to conduct those types of surgeries.
Researchers say providing surgical teams with troubleshooting workshops, including using computer simulations, can help them more easily adjust in the event of a malfunction or interruption during surgery.
Meanwhile, some experts say they are skeptical of the new data because it fails to address the injury and death rates of non-robotic surgery. Without that data as a comparison, it is hard to decide whether robots are resulting in better or worse surgical outcomes, according to MIT Technology Review (Wagstaff, NBC News, 7/21; Dvorak, FierceHealthIT, 7/21; BBC News, 7/22; MIT Technology Review, 7/20).
Vik Srinivasan, Senior Analyst
The robot is ultimately a tool, not so different from a scalpel. Like a scalpel, it can do harm in untrained hands, just as it can prove life-saving in the hands of a highly trained surgeon.
If hospitals have made the decision to purchase a da Vinci robot, they need to take ultimate responsibility for making sure that this clinical technology is used appropriately at their institutions. That means making sure they have the protocols and governance in place to guide their surgeons. We see this taking the form of volume thresholds for credentialing and re-credentialing, creating quality committees that involve surgeons and administrators, and setting clear processes for adopting new procedures on the platform.
If your organization doesn't currently have a da Vinci robot, there are many things to consider before making the investment.
The Advisory Board's Rachel Klein explains why the appeal of the robot has diminished in recent years, and how this expensive technology has changed from a way to differentiate your organization to, in many cases, simply the cost of doing business.
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