In a recent issue of Medical Device Daily, Integrity Life Sciences (ILS; Tampa) reported that FDA will investigate the use of robotic surgery, a move said to be sparked by a tripling of adverse events reports between 2008 and 2012.
The company statement indicates that the more than 1,400 U.S. hospitals deploying surgical robots have filed enough reports to render a report rate that is a "higher than acceptable rate," although the announcement acknowledges that the data do not clearly disclose whether "the failure is attributable to the robot itself, operator error, the FDA marketing clearance process, or the training provided by the manufacturers." Integrity says that FDA indicated that it will "make a further determination in this matter and offer industry guidance."
The ILS statement indicated that a soon-to-be-published paper by a researcher with Johns Hopkins University (Baltimore) likely sparked FDA's interest. Martin Makary, MD, said to be one of the authors of the paper, is purported to have alleged that adverse events are under-reported.
The Food and Drug Administration asked surgeons at key hospitals to list the complications they may have seen with the machines, which cost about $1.5 million each and were used last year in almost 500,000 procedures. The doctors were also surveyed on which surgeries the robots might be most and least suited for, and asked to discuss their training.
The surveys were sent to hospitals that belong to a product safety network overseen by the FDA. What the agency is trying to determine is whether a rise seen in incident reports sent to the agency are “a true reflection of problems” with the robots, or the result of other issues.
In a move that seemingly looks to head off any of the trouble for the machines, David Samadi, MD, appears to have borrowed a page out of the National Rifle Association (Washington) handbook, noting that the surgical robots don’t make mistakes, rather, the surgeons using the machines are the ones responsible for potentially catastrophic surgical errors.
Samadi, Chief of Robotics and Minimally Invasive Surgery and Vice Chairman of the Department of Urology at the Mount Sinai Medical Center, performs a high volume of robotic prostate surgeries and argues that more stringent robotic surgery training requirements are the solution to protecting patients.
Samadi has performed more than 4,500 robotic prostate cancer surgeries, employing Intuitive Surgical’s (Sunnyvale, California) da Vinci surgical robot in his SMART Samadi Modified Advanced Robotic Technique (SMART) prostate removal procedure.
Samadi stressed the safety of robotic surgery with one critical caveat--the robot does not perform the surgery. That responsibility, he says, falls squarely in the hands of the surgeon.
"The robot is a tremendous technology that reduces time in the operating room and improves patient recovery. But you have to know what you're doing; the learning curve cannot be overlooked," he said.
Samadi expressed concerns that the training recommendations for these surgical robotic systems may be "watered down" by some hospitals eager to acquire and promote the innovative technology. "Many hospital-level requirements for performing robotic surgery are insufficient," cautioned Samadi. "We're now seeing the fallout of institutions that may have rushed to market with a shiny new robot and less experienced surgeons. My hope is that the FDA can lead us to enforced national standards for robotic surgeon training and specific procedure experience. Our patients deserve that level of safety and assurance."
In a Bloomberg story, Intuitive said it faces 26 lawsuits from people alleging injuries tied to its da Vinci surgical system, according to a regulatory filing in April. The company also has entered into agreements with some plaintiff lawyers temporarily suspending the statutory deadline for filing suits for other patients who say they were hurt by robotic surgery, it said. Intuitive has seen a “substantial increase” in such claims, according to the filing.
The Bloomberg story discussed how the stress and complications from a lengthy prostate operation assisted by an Intuitive Surgical robot hastened a patient’s death from heart disease.
The patient, Fred Taylor might have lived five more years, and had a much better quality of life, had he never suffered the consequences of the botched robotic procedure in 2008, John MacGregor, a cardiologist and professor of medicine at University of California, San Francisco, told a jury as a state court trial entered its third week in Port Orchard, Washington.
“A number of complications put stress on his heart and his body in general,” MacGregor said. “I think the prostatectomy and the aftermath of his prostatectomy accelerated his cardiovascular disease and hastened his death.”
Lawyers for Intuitive have argued that Taylor never should have been a candidate for robotic surgery because of his obesity, and that he didn’t regularly take his prescriptions to control his heart-disease risks.
Under cross examination by defense attorney Jeffrey Johnson, MacGregor agreed that Taylor’s out-of-control diabetes, morbid obesity and his family history of cardiac disease risks put him at greatest risk for eventual death from coronary artery disease. Defense lawyers had previously said that medical records indicate Taylor’s health conditions were better controlled when Taylor was in a hospital or a rehabilitation facility.
After seven hours of trouble with robotic surgery on Taylor in September 2008, urologist Scott Bildsten and other doctors turned to traditional surgery and then emergency care to repair a rectal laceration. Bildsten had performed 100 successful prostatectomies using a traditional procedure and hadn’t used the da Vinci system on a patient unassisted.
Bildsten testified that while Intuitive deemed him ready after one day of the company’s training and two supervised operations, he now knows he needed more training to perform the robotic surgery unassisted.
So what do you think, is operator error strictly to blame for the problems with these robotic surgical systems, or are there flaws of the HAL 9000 variety contained within the devices?