Executive Summary
Emerging technology poses a challenge to the credentialing and privileging process. Standard procedures may be ill-suited to determining a surgeon’s competence with new technology.
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Hospitals must develop their own criteria for credentialing new technology.
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Proctoring should be a key component, but it is not enough.
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Simulation and higher training standards will be necessary.
Medical technology is evolving at such a fast pace that hospital credentialing and privileging programs can’t keep pace. The result is that too many surgeons are being allowed to use new devices and technology without proving their competency to the hospital.
Patients will suffer the consequences, experts say, and hospital quality leaders will be blamed for not keeping up with the times.
Credentialing surgeons in new technology is necessary whether the physician has been in practice for decades or is fresh out of a residency, notes Robert Wachter, MD, interim chairman of the Department of Medicine and chief of the Division of Hospital Medicine at the University of California, San Francisco. A surgeon may be highly experienced and skilled but still not be qualified to use a device or technology that just became available, he says.
“It used to be that we could take surgeons right out of medical school and be reasonably confident that they were competent in a number of different procedures. The growing use of technology is changing that,” Wachter says. “Given the changes in surgery and accreditation, there are surgeons who finish their training and really are not capable of independent practice and need further training.”
Like early days of laparoscopy
The current challenges with credentialing new technology are reminiscent of the problems with credentialing laparoscopic cholecystectomy in the 1990s, Pradarelli notes. Surgeons adopted minimally invasive surgery with enthusiasm and it was not uncommon for them to operate on patients after only a weekend training course by the manufacturer. It wasn’t long before there was a wave of malpractice cases alleging that the hospitals allowed unqualified surgeons to use new technology on patients.
“Some time after their two days of training in Italy, they were asked if they felt ready to do the surgery and a very small percentage of them said yes. When they were asked if they do the surgery now independently, a very large percentage said they did,” he recalls. “We determined later that there was a substantial learning curve and you weren’t really competent in that procedure until you had done about 50 cases.”
The healthcare community will not find much help from government agencies when assessing new technology and surgeons’ competence with it, says Jason C. Pradarelli, MD, a physician at the University of Michigan Medical School, and the University of Michigan School of Public Health in Ann Arbor. Pradarelli and colleagues recently authored an essay in the Journal of the American Medical Association on this challenge. (The essay is available online at http://tinyurl.com/of5wqbx.)
Although the Food and Drug Administration (FDA) strictly regulates new drugs, it exerts minimal oversight for new devices and no oversight for new surgical techniques, Praderelli says. That lack of oversight came to light recently when the da Vinci surgical robot was linked to numerous injuries and critics questioned whether surgeons had been adequately trained and properly credentialed by the hospitals. (See the story later in this issue for more on the da Vinci robot.)
Get friendly with surgery chair
The best strategy for addressing this issue is to foster good communications between the credentialing body at the hospital and the chairs of relevant clinical departments, most notably the department of surgery, Pradarelli says. The goal is to stay abreast of what technology is emerging in that field so that the credentialing committee is not caught off guard when a surgeon wants to bring in the latest technology.
Once you know that surgeons at your hospital are interested in a certain technology, you can begin looking for guidance on how to credential them. Many specialty physician groups — the Society of American Gastrointestinal and Endoscopic Surgeons, for instance — have guidelines for ensuring that a physician is competent in a specific technology or device. A specialty group’s guidelines won’t be enough for hospital credentialing, but they will give you a starting point.
“There are times when the surgeon or physician might try out new technology or procedures without people above them in the credentialing body even knowing,” he says. “Being aware of the innovations is the first step, and you also want a good relationship so that the chair of that department lets you know when new technology is coming to the hospital.”
All of the specialty group guidelines emphasize training and proctoring, Pradarelli says. Mini-fellowships also are suggested in many cases. These steps are much more robust than a day or two of training at the device manufacturer, or a day in the cadaver lab, he notes.
Proctoring is not enough
That still may not be enough. The current credentialing process that relies on proctoring and peer review is inadequate for much of the new technology in healthcare, Wachter says. The usefulness of proctoring is limited, he notes, because collegiality among surgeons can make it difficult for one to say that another is not qualified.
“I think the answer has to lie somewhere with simulation and higher training requirements,” he says. “The surgeon will have to undergo training that is much more substantial than a weekend course, prove their skills in simulation, and then you still don’t want them doing this procedure alone when they get back to the hospital.”
The credentialing committee will have to work with the department head to determine how much experience is enough for allowing the surgeon to operate alone. There may be empirical data with some procedures will provide a threshold, but in others the department head may have to determine a number based on past experiences and knowledge of the field, Wachter says.
But what constitutes new technology or a new procedure? That can be hard to define, so Pradarelli says that is one reason you must have good communications with the department heads. In some cases you will have to rely on that person to give you a heads up that there is a new technology for the credentialing committee to address, or that the use of a certain device changes the procedure in such a way that it should be considered new.
Wachter calls attention to a 2013 study that assessed the technical skills of surgeons new to bariatric surgery. Surgeons were asked to videotape their procedures and send their best examples for evaluation by experienced bariatric surgeons. The results were not encouraging, suggesting that standard credentialing procedures are inadequate. (See the story on p. 103 for more about the study.)
“Right now it’s the Wild West here,” Wachter says. “A new procedure comes out and hospitals are left to devise their own standards for what means the surgeon is qualified to operate alone. This is an area that has been woefully neglected in the safety and quality arena.”
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Jason C. Pradarelli, MD, University of Michigan Medical School, University of Michigan School of Public Health, Ann Arbor, MI. Telephone: (414) 881-4229. Email: [email protected].
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Robert Wachter, MD, Interim Chairman of the Department of Medicine and Chief of the Division of Hospital Medicine at University of California, San Francisco, CA. Telephone: (415) 476-5632.
