Do Surgical Robots Need a Second Opinion?

What was it that Ben Franklin said: “An ounce of prevention is worth a pound of cure.”

A recent paper, Robotic Surgery & The Law in the USA—A Critique, indicates that manufacturers of robotic surgical tools, a sizeable swath of the U.S. medical establishment and government officials seem to prefer the pound of cure.

RBR50 company Intuitive Surgical‘s new da Vinci Xi just won the approval of the U.S. Food and Drug Administration (FDA), paving the way for the company to start selling it.  More than a decade previous, 2000, the FDA similarly approved Intuitive’s very first da Vinci; the company has since racked up some 1.5M robotic surgeries with its robots.

However, as Sulbha Sankhla, author of Robotic Surgery & The Law in the USA—A Critique, points out: “Years after the FDA first approved the da Vinci, there is still no industry standard for training and credentialing of doctors to use the robot, beyond a basic course by the manufacturer.”

It seems rather odd that the woman who cuts my hair seems to be more closely monitored than the surgical robot that might one day remove my prostate.

Between January 2000 and August 2012, thousands of mishaps were reported to the FDA involving the da Vinci robot, reported the New York Times. “In the vast majority of cases, the patient was not harmed, but among the reports were 174 injuries and 71 deaths related to da Vinci surgery, according to a study published…in the Journal for Healthcare Quality.

“We’re not learning from our performance,” said study coauthor Martin Makary, MD, MPH.

More injuries and deaths are linked to da Vinci robotic surgery than meet the eye, according to this study, published in August of 2013. Dr. Makary said the 8 cases uncovered by his study, including the 5 never submitted to the FDA, make up a “sampling” of a large but unknown number of unreported or misreported AEs (Adverse Events) associated with da Vinci surgery.

“We think that based on the sample, the 245 reported cases represent a small fraction of the true events out there,” said Dr. Makary (associate professor of surgery at the Johns Hopkins University School of Medicine). The number of reported cases, he added, “seems very low, given the discussion of these events in the surgical community.”

With almost 1,400 U.S. hospitals —out of a total of 5,000 registered hospitals—there’s at least one da Vinci system in service. Each one costs about $1.45 million, plus $100,000 or more a year in service agreements (the new da Vinci Xi rings in at $1.85M; the dual-console version for $2.3M).

With such expensive surgical tools operating on such priceless patients; with Intuitive shares topping near $500 and being gobbled up by investors, one would think that the manufacturer would opt for the ounce of prevention. However, it doesn’t seem to be the case.

The Journal of Robotic Surgery this month counters with, Training current and future robotic surgeons simultaneously: initial experiences with safety and efficiency, writing that its experience shows, “A robotic general surgery program can be initiated while concurrently instructing surgical trainees on robotic surgery in a safe and efficient manner.”

Is that really enough? Could and should more be done by the industry to ensure patient safety?

As Sankhla sees it: “Robot-assisted surgeries are so new that patients, doctors, surgeons, hospitals, insurers, manufacturers, and the FDA are still trying to determine their efficacy and risks and when would it work better especially in comparison to alternative surgical methods.”

Is it better to err on the side of too much training and prevention rather than too little, which also seems to be the case?

The legal wrath awaiting trespassers that she potently sets out in her paper is downright scary. It should be more than enough to shock all parties—manufacturers, hospitals and government alike—to immediately reach out for the ounce of prevention.

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