|Intuitive Surgical's da Vinci surgical robot faces scrutiny over alleged safety issues.--Courtesy of Intuitive Surgical|
Robotic surgery-related complications are grossly underreported, Johns Hopkins researchers have concluded, and they argue this leaves an uncertain picture of how safe the devices actually are.
Their report, published in the Journal for Healthcare Quality, comes as surgical robots are in the midst of increased scrutiny in general. Industry leader Intuitive Surgical ($ISRG), for example, faces lawsuits and some regulatory scrutiny about the safety and efficacy of its signature da Vinci surgical robots. But the findings also hit as the robotic surgical boom has continued almost unabated. The researchers note that 1,400 surgical robots were installed in U.S. hospitals as of 2011, a jump of 600 over the previous four years.
The researchers note that more than 1 million robotic surgeries have been performed in the U.S. since 2000, but hospitals only reported 245 complications to the FDA (including 71 deaths). And the low number comes even as procedures using surgical robots jumped over 400% in the U.S. between 2007 and 2011, the researchers note.
"The number reported is very low for any complex technology used over a million times," Martin Makary, study author and associate professor of surgery at the Johns Hopkins University School of Medicine, said in a statement.
They looked at reporting of adverse events to the FDA from Jan. 1, 2000 to Aug. 1, 2012, plus legal judgments, news media reports and court records, and then cross-referenced to see if everything matched. What they found: eight cases weren't appropriately reported to the FDA. Five of those were never filed with regulators at all, and two were only filed after the press reported the specific cases first.
And while complications such as excessive bleeding were reported, there were other problems that may not have been reported correctly, or at all, the researchers speculate. For example, they note that surgeons can accidentally cut the aorta during robotic surgery because they can't feel how firm it is. But the data was unclear as to whether this would be reported as a surgeon- or device-related problem. Also, they cite a previous study in which nearly 57% of surgeons surveyed anonymously said that they had to convert to laparoscopic or open surgery after the robotic device malfunctioned. And it is unclear how, or if, those errors are reported with the FDA.
Makary noted in his statement that his teams findings is as much about unanswered questions in measuring a wider impact of robotic surgery-use. A broader roster of errors must be tracked as device-related problems, he said.
"Decisions should not be made based on the information in the FDA database," he said in a statement. "We need to be able to give patients answers to their questions about safety and how much risk is associated with the robot."
- read the release
- here's the journal abstract