The growing popularity of robotic surgery over the past decade has created a "slapdash" system of reporting complications that raises patient-safety concerns, according to Johns Hopkins researchers.
In a new report published online in the Journal for Healthcare Quality, the Johns Hopkins team says that of the 1 million or so robotic surgeries performed since 2000, only 245 complications — including 71 deaths — were reported to the U.S. Food and Drug Administration. But the researchers suggested these figures may underestimate the actual level of adverse events, because of "haphazard" reporting protocols.
Hospitals are required to report any complications or device malfunctions to the manufacturer, which in turn is required to report them to the FDA. But this doesn't always happen, the researchers said.
"The number reported is very low for any complex technology used over a million times," said Martin A. Makary, M.D., an associate professor of surgery at the Johns Hopkins University School of Medicine.
"Doctors and patients can't properly evaluate safety when we have a haphazard system of collecting data that is not independent and not transparent. There may be some complications specific to the use of this device, but we can only learn about them if we accurately track outcomes."
The researchers cited several incidents reported in the national news media that were not reported to the FDA until after the stories appeared in the press. Dr. Makary said it's likely many other incidents go unreported.
"We need innovation in medicine and, in this country, we are tremendously good at introducing new technologies," he said. "But we have to evaluate new technology properly so we don't over-adopt — or under-adopt — important advances that could benefit patients."
Robot-assisted surgery is used in a variety of operations from hysterectomy to removal of the gallbladder to repair of the mitral valve of the heart. Surgeons make small incisions are made through which remote-controlled instruments are inserted into the body. The surgeon directs the movement of the instruments via console.
The new study found the number of procedures performed using robotic technology increased by more than 400 percent in the United Between 2007 and 2011, and by more than 300 percent internationally. At the end of 2011, there were 1,400 surgical robots installed in American hospitals, up from 800 just four years before.
Dr. Makary's team reviewed FDA reports of adverse events from Jan. 1, 2000, to Aug. 1, 2012, and searched legal judgments and news reports for cases. They then compared the findings to see if they matched. The results turned up eight cases that were not appropriately reported to the FDA, five of which were never filed and two of which were filed only after a story about them appeared in the press.
The results also showed the procedures most commonly associated with death were gynecologic (22 of the 71 deaths), urologic (15 deaths), and cardiothoracic (12 deaths). The cause of death was most often excessive bleeding.
Dr. Makary said the findings indicate uniform standards need to be established for reporting adverse events related to robotic devices. One option: Create a database like the one maintained by the American College of Surgeons in which independent nurses identify and track adverse events and complications of traditional operations.
"We need to be able to give patients answers to their questions about safety and how much risk is associated with the robot," he said. "We have all suspected the answer has not been zero. We still don't really know what the true answer is."
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