The use of surgical robots has increased by more than 400 percent in the US over the past six years. But a new study published in the Journal for Healthcare Quality suggests that there’s underreporting of complications resulting from robotic surgeries.
Robot-assisted surgery is a minimally-invasive method in which a small incision allows remote-controlled instruments to be inserted into the body. The instruments are then controlled during the procedure by the surgeon using a console.
At the end of 2011 there were more than 1,400 surgical robots in US hospitals. Now, one group of researchers from Johns Hopkins University school of medicine are saying the technology’s badly monitored, and lacks a robust and transparent reporting system for resulting complications.
“Many drugs when they’re introduced to the market are closely monitored, but with devices we simply approve them, they go to market and we’re not really asking is this better for patients in a systematic, audited, structured way,” says co-author of the study, Dr. Martin Makary.
Makary says during their research they found multiple instances of complications from robotic surgery that had been covered in the media, but never reported to the U.S Food and Drug Administration (FDA).
Although hospitals are required to report all complications to manufacturers, and manufacturers in turn are required to report incidents to the FDA, that’s not happening 100 percent of the time, he says.
Makary says this type of underreporting and haphazard collection of data means patients and doctors can’t properly evaluate how safe or useful a technology is.
But, Dr. John Monson, head of the Surgical Health Outcomes and Research Enterprise at the University of Rochester in western New York, says there’s a wealth of reporting. It’s just not always at the regulatory level.
He says most hospitals have a very thorough system for recording complications that occur in surgeries, and those records filter down to the wider community.
“There is a huge [amount of] literature in scientific publications that are robust reports and peer reviewed assessments of outcomes of, for example, robotic or laparoscopic surgery that have documented exhaustively the rates of complications.”
Despite this, Dr. Martin Makary says the medical system isn’t held to the same reporting standards as many financial or business institutions, and that’s a flaw in the system.
He says unless more rigorous reporting practices are introduced, it will be difficult to track the efficacy of increasing amounts of medical technology.