A study presented at the 50th Annual Meeting of the Society of Thoracic Surgeons made headlines this week for revealing that from 2000 to 2013, 144 patients have died while or after undergoing surgeries performed with robotic assistance.
While "robotic surgery death" makes for good headline fodder, the big question is whether that's more than the average for traditional surgical procedures. There are tens of millions of surgical procedures performed every year, according to the CDC's figures. Unfortunately, the CDC doesn't break out robotic procedures from manual ones, leaving deaths from surgical procedures grouped under a larger umbrella called "complications from surgical and medical care." Without that distinction, it's not clear from CDC data if 144 robotic surgery deaths over 13 years is a rate we should be proud of or horrified by.
The new study relied on a different data set pulled from the FDA's Manufacturer And User facility Device Experience (MAUDE) database, which is used to collect incident reports from manufacturers, professional operators, and patients of medical technologies. Over the course of those 13 years, over 10,000 incidents were reported for surgeries involving robotic systems, like the da Vinci Robotic Surgical System.
Reporting to the MAUDE database is only partly mandatory. Manufacturers have to submit incidents they're aware of, but it's voluntary for medical professionals. This means that the numbers of incidents are very likely underreported.
"The results are about the same as what you would see with laparoscopic surgery," Dr. Jai Raman, one of the authors of the study, told me. "So [robotic surgery is] not significantly better or significantly worse than other technologies as it stands... The purpose of doing all this, was to see if we could identify specific areas where the human/machine interface could be improved, and specific areas where safety could be improved upon, by simple things like the surgical team understanding how to troubleshoot these complex machines."
Laparoscopic surgery, in which a snakelike camera is inserted into a small incision, makes for a compelling comparison on the surface. It's a procedure that's been used for both diagnosis and surgery, and is over 100 years old. The laparoscope itself has advanced from little more than a thin microscope to a digital camera with its own internal chips. By comparison, robotic-assisted surgery is less than 30 years old, and the da Vinci was only approved by the FDA in 2000. Robotic surgery systems are the logical next step for surgery, but they still have a lot of research and development ahead.
Most systems, including the da Vinci, are about as autonomous as a claw machine in an arcade. They're a telemanipulation platform designed to allow surgeons to work further away from the operation and allow them to operate on an area with smaller incisions and greater stability; ideally making surgeries less invasive and easier to recover from.
"It's as good or as safe as any other surgical procedure. It's not any more dangerous."
The study found that the kinds of issues that occur with robotic surgery platforms are the same kinds that can be expected in any sufficiently advanced electronic device: video/imaging errors, components falling off the device, electrical circuits arcing and overheating, spontaneous powering on/off, and so on. That all sounds horrible, and during a complicated surgery, any one of those things can be fatal.
There are two ways to make the use of this technology safer, and reduce the number of accidents and deaths. The first, as Dr. Raman points out, is to make sure surgical teams get the proper amount of training using them. The second is to ensure that the certification of the systems themselves is as foolproof as possible. That second part is exponentially harder than the first.
Ryan Calo, an assistant professor of law at the University of Washington Law School and co-director of the school's Tech Policy Lab, has some ideas about that. He's written papers about the government's glaring lack of experience when it comes to evaluating new robotic technologies before. Robotic surgery technology is here to stay, and is going to get more advanced. How will regulators respond?
In a conversation with Motherboard, he said, "What will the FDA do when Google and Johnson & Johnson come to it and say, 'Hey we have this autonomous robotic surgeon. It's just like what you already have, it's just that we added some software to it.' How would the FDA go about evaluating that?"
"I'm not against robot surgery in any way," he added. "What I'm saying is that when you have a hammer, everything looks like a nail, and when you lack expertise, you're not able necessarily to see the way that new technologies differ from what came before."
Calo has written before about the need for some sort of "Federal Robotics Commission" to do just what he's describing, making sure the proper steps are taken to ensure robotic tech is used safely and correctly. These surgery platforms aren't autonomous yet, and before they are we need to understand them better, without scaremongering. For now, Dr. Raman is definitive about their current applications.
"It's as good or as safe as any other surgical procedure. It's not any more dangerous," he said. "Definitely not."