A recent court ruling over liability for da Vinci robotic surgery gone wrong has sparked a debate over how physicians should train to use new devices. Do credentialing methods keep up with the pace of technological change?
When a patient suffered a cascade of complications after robotic surgery, his lawyers thought the doctor, the hospital, and the device maker should be liable. But in a malpractice case involving the da Vinci Surgical System, the courts disagreed.
The 2013 decision that Intuitive Surgical, the maker of da Vinci, was not responsible for the action of a poorly trained doctor may be good news for the medical device makers. The ruling is under appeal, but the case raises a question for hospitals, according to a recent commentary published in the Journal of the American Medical Association: Do hospitals need to strengthen traditional credentialing programs to ensure that doctors are adequately trained in the use of new devices?
A group of researchers from the Center for Healthcare Outcomes and Policy at the University of Michigan thinks so.
"By concluding that Intuitive was not negligent, this decision implies that the medicolegal responsibility for training, credentialing, and privileging surgeons to use new technologies belongs to physicians and the hospitals (or other institutions) where they work," they wrote in a JAMA opinion article titled "Hospital Credentialing and Privileging of Surgeons: A Potential Safety Blind Spot."
However, guidelines for how do to that are "vague and scarce," says lead author Jason C. Pradarelli, a fourth-year medical student at the University of Michigan currently working with the school's clinical research program.
"We were hoping to start a discussion about safely introducing new procedures and where that responsibility lies," he said in a recent conversation.
Mary Logan thinks that discussion is long overdue. She's the president of the Association for the Advancement of Medical Instrumentation, a nonprofit group that develops standards for the development and use healthcare technology. Logan says the JAMA article was sound and timely. Many hospitals assume that traditional approaches to credentialing, like board certification, ensure that doctors have the skill they need to adopt new tools. But rapid technological change makes it hard for doctors to keep up.
"Healthcare delivery has become so technology dependent, that's not a fair assumption any longer," she says.
The JAMA article notes that the Joint Commission gives medical staff organizations the responsibility for credentialing. However, least 25 states define "negligent credentialing" as a valid malpractice claim against hospitals, making institutions liable for the medical errors of their poorly trained doctors.
In the case in question, the surgeon was a board-certified urologist who had performed open prostatectomies for ten years. As required for hospital credentialing, he had completed Intuitive training to use the da Vinci system. But, for his first unsupervised case, he operated on a morbidly obese patient who "would have presented a challenge for nearly all inexperienced operators," the article notes. The patient suffered from "rectal laceration leading to reoperation and colostomy, sepsis, acute renal and respiratory failure, stroke, and incontinence."
Acknowledging their responsibility, the surgeon and hospitals settled individual malpractice lawsuits out of court, according to the article. The device maker went to court, where a judge ruled it not liable in the case.
Ensuring adequate training beyond surgical residency or fellowship "is a major challenge for hospitals that want to grant privileges for new procedural skills," according to the article. The authors recommend against relying on manufacturers for training. Instead, institutions need to evaluate the efficacy of programs designed to ensure that doctors are trained to use new devices and procedures, including board certification and training programs offered by professional groups.
The authors call for an effort to identify and validate "effective and novel" approaches to credentialing, including the use of "peer review to better assess competency in new procedures." Pradarelli cite an example of the peer rating program developed at University of Michigan to assess the technical skills of bariatric surgeons.
In a study of that approach, bariatric surgical procedures were videotaped and rated by ten peer surgeons. The surgeons ranked highly by their peers had lower rates of reoperations, readmission, and visits to the emergency department. Their patients also suffered from fewer complications.
A spokesman for the Advanced Medical Technology Association, a device industry trade group, declined to comment on the JAMA article: "This is not an issue that we have a position on."
Michael Carome, MD, director of Public Citizen's Health Research Group, a watchdog group that tracks drug and device safety, says, "Hospitals want the newest device so that they can promote and market themselves as having the most advance technology."
Some so-called innovations are new, but not necessarily better, he says. (Debate continues over the da Vinci system, for example.) New technologies are increasingly complex, so the institutions need to ensure that doctors are trained to use them, Carome says.
The Michigan researchers came to a similar conclusion in their paper: "As surgical innovations continue to emerge, and as pressures from patients and hospital administrators to be on the cutting edge of technology continue to increase, strengthening hospitals' credentialing and privileging for new procedures should be a high-yield target for improving patient safety."