Are robotic tools truly safe, or are we being mislead by inaccurate and missing incident reports?
The New York Times documents the case of Erin Izumi, who underwent robotically assisted surgery to treat endometriosis. Ten days after the 11-hour operation, Izumi was rushed to an emergency room, where doctors found that her colon and rectum had been torn during the operation -- resulting in hospitalization for five weeks.
Hospitals and medical device manufacturers are required to report such incidents to the U.S. Food and Drug Administration (FDA), but no report was made about this case -- the manufacturer only became aware of the issue once Izumi filed a lawsuit.
A team of researchers from Johns Hopkins say this is not the only time such reports have gone astray.
Published in The Journal for Healthcare Quality, the team says that there is evidence that botched operations are not always reported. In particular, Intuitive Surgical Inc's da Vinci system -- the equipment used in the above case study -- has been on the market for a decade and is linked to 174 injuries and 71 deaths.
The team say that such events associated with the da Vinci are "vastly underreported."
While robotic surgical tools have the potential to reduce human error, improve efficiency and perform complex procedures, the authors believe that too little is known about injuries and fatalities caused by the equipment.
Despite safety concerns, robotic surgical tool use has grew by over 400 percent between 2007 and 2011. Roughly 1,4000 of the $1.5 - $2.5 million da Vinci systems have been purchased by hospitals in the United States.
Vice president of corporate communications at Intuitive Angela Wonson said the research "gives the misleading impression that Intuitive Surgical has systematically failed in its obligation to timely report known adverse events to the F.D.A," and the firm "takes this requirement very seriously."
Senior author of the paper Dr. Martin A. Makary, an associate professor of surgery at Johns Hopkins, said:
"This whole issue is symbolic of a larger problem in American health care, which is the lack of proper evaluation of what we do. We adopt expensive new technologies, but we don't even know what we're getting for our money -- if it's of good value or harmful."
Via: The New York Times
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