Despite widespread adoption by hospitals of surgical robot technology over the past decade, a “slapdash” system of reporting complications paints an unclear picture of its safety, according to Johns Hopkins University researchers.
In a 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 Food and Drug Administration.
“The number reported is very low for any complex technology used over a million times,” Martin Makary, M.D., an associate professor of surgery at the Johns Hopkins University School of Medicine, said in a statement accompanying the research's publication. “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.”
As part of their study, the researchers found several incidents reported in the national news media that were not reported to the FDA until after the stories appeared in the press, even though the incidents took place long before the media exposure. Makary said it’s likely many other incidents go unreported, never to be captured by research like his or by the FDA.
Makary and his colleagues reviewed the FDA adverse events database from Jan. 1, 2000, to Aug. 1, 2012. They also searched legal judgments and adverse events using LexisNexis to scan news media, and PACER to scan court records. The cases were then cross-referenced to see if they matched. They found that eight cases 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 researchers also reviewed all reported complications. 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. In cases where patients survived, hysterectomy by far had the most complications (43 percent of injuries).
Makary said there needs to be standardized reporting of adverse events related to robotic devices. One rare complication that occurs, he says, is that a surgeon can accidently cut the aorta because the surgeon cannot feel its firmness. For reporting purposes, however, it’s unclear whether such an event is surgeon error or device-related error.
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