“We still don’t really know what the true answer is,” says Johns Hopkins University School of Medicine surgical professor Martin A. Makary.
That is unfortunate, given that the question pertains to surgical error and the number of mistakes that are made when surgeons use robotic tools as assists in operations.
Robotic surgery has grown from being a relative rarity in hospitals across the United States, including in New Jersey, to an extremely fast-growing field. Statistics indicate that robot use in surgery increased fourfold over a recent four-year period and that about 1,400 surgical robots were in use in hospitals across the country by the beginning of last year.
Doctor Makary and a Johns Hopkins research team took a close look at this escalating phenomenon, and note a reason to be troubled by it.
The concern: adverse events associated with robotic surgery are being underreported, with obvious implications for improving safety and ensuring patients’ health.
“The number reported is very low for any complex technology used over a million times,” says Makary. In fact, Makary’s team notes that only 245 complications involving one million-plus surgeries conducted since 2000 were reported as required to the Food and Drug Administration. Federal law mandates that hospitals report adverse outcomes to medical device makers, which then convey them to the FDA via its adverse events database.
That number doesn’t accurately correlate with additional adverse reports in media stories and court records, says Makary.
The Johns Hopkins researchers note that, until greater accuracy is achieved, there will flatly remain an element of the unknown about robotic surgery safety and outcomes, and whether given mistakes owe to human error or technological glitches.
“[W]e can only learn … if we accurately track outcomes,” says Makary.
Source: Health Canal, “Robotic surgery complications underreported, Johns Hopkins study suggests,” Sept. 5, 2013