Robotic surgery has been one of the most touted medical care developments in the past several years, but the technology has also invited its share of controversy. While advocates claim that robotic tools can increase the precision of surgical procedures and reduce recovery times, detractors have argued that the technology introduces a number of high risk of complications while increasing the cost of care.
A recent flurry of attention has surrounded the technology due to several lawsuits and an investigation by the FDA. At the same time, researchers are looking for ways to improve the software of such tools and increase safety.
A booming technology
The dominant market force in robotic surgery is Intuitive Surgical. The company’s da Vinci robots first appeared in hospitals 13 years ago, and there are now more than 2,500 deployed worldwide. In total, around 450,000 robotic surgeries were performed last year, an increase of 25 percent, according to CNBC. The machines cost more than $1.5 million each. They are mostly used in prostate and gynecological surgeries, although their use has expanded. Technically, they are not true robots in that they are not fully autonomous. Rather, such tools are considered hybrid, or cyber-physical systems.
Some studies have shown that robotic surgeries have improved surgical outcomes, but critics argue that the technology has been overly hyped through aggressive marketing and sales quotas at Intuitive, CNBC noted. Hospital officials can feel driven to use the tools more than necessary to justify the large expense, the Boston Globe reported. Additionally, some detractors worry that training requirements are not substantial enough for the machines.
At least 10 lawsuits have been filed in the past two years, CNBC reported. The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, a voluntary reporting tool, has listings of 85 deaths and 245 da Vinci injuries since 2000, while a separate independent report listed 4,600 adverse events. Out of the 1.5 million procedures carried out during this time, those numbers are statistically insignificant, but critics say the true rates are underreported. Common complications include impotence and incontinence. Temporary nerve damage resulting from the suspended operating position patients are often kept in is a frequent complaint as well.
The FDA recently opened a probe into the safety of Intuitive’s machines, causing its stock to tumble, Bloomberg reported. According to many onlookers and analysts, there is room for additional review of the technology and added safeguards.
“This tool was brought to us [by the manufacturer] solely as a marketing device,” Dr. Peter Dunn, director of perioperative services at Massachusetts General Hospital, told the Globe. “The medical community didn’t do what it should have done – say, ‘Wait a minute, hold on.’”
Improving confidence with source code analysis
While surgical robots can enable a level of precision that human surgeons can’t match, a software flaw can create serious safety issues. A surgical instrument might pierce an organ outside of a surgeon’s view – or outside of the spatial parameters a surgeon has designated. This latter flaw was uncovered in a research surgical robot being tested by Carnegie Mellon and Johns Hopkins University researchers. The team worked to develop a form of source code analysis that could reliably detect bugs in such systems. Testing surgical robots is inadequate because of the number of possible circumstances the devices could encounter.
“Because the consequences of these systems malfunctioning are so great, finding a way to prove they are free of design errors has been one of the most important and pressing challenges in computer science,” said André Platzer, assistant professor of computer science at Carnegie Mellon.
As legal, safety and FDA compliance concerns mount surrounding robotic surgery technology, ensuring flawless operation is paramount. Manufacturers of sensitive medical devices need to adopt source code analysis processes such as those being used by leading researchers in the field to meet regulatory standards and reassure industry professionals. With static analysis software, vendors can decrease the likelihood of a software flaw being at the heart of future legal incidents.
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