For all the attention hospitals have paid to patient safety in the last decade, a big blind spot is making them – and their patients – vulnerable to harm, according to a new Viewpoint piece in JAMA by members of the University of Michigan Institute for Healthcare Policy and Innovation.
Specifically, the lack of robust processes for credentialing and privileging surgeons on new technologies and procedures poses a major issue that hospitals and professional societies should address, say U-M medical student Jason Pradarelli and U-M Medical School faculty members Justin Dimick, MD, MPH, and Darrell Campbell, Jr., MD, in the new piece.
Of course, the companies that make devices used in new procedures – such as surgical robots – now routinely offer training to surgeons. The companies' representatives have previously taken part in hospital credentialing processes to decide which surgeons are permitted to perform those operations.
But as a current court case reviewed by the authors shows, it is the surgeon and hospital that face the potential legal liability if a patient suffers or alleges harm.
In that case, a jury ruled that Intuitive, the manufacturer of a surgical robot, was not liable for the injury and death of a patient who had a robotic prostatectomy. That’s despite the fact that the surgeon’s only training in the procedure had been from the company’s own program, and the hospital’s credentialing criteria were based entirely on the company’s program.
In the Intuitive case, the first of its kind to make it to court, the hospital and surgeon settled out before the trial began. The case against the manufacturer is now in appeals and a ruling could come this summer.
More than 20 other cases by patients alleging harm from surgeons using the same manufacturer’s product and training are pending, and their outcome will depend on the first case’s outcome.
In an interview with JAMA available on the Viewpoint page, Dimick notes that very little guidance exists for surgeons or hospitals about what qualifies as adequate training on new procedures and technologies.
“We should acknowledge that new technologies and new procedures have benefits, but that sometimes the technology gets ahead of the evidence,” he says, adding that often the manufacturer’s marketing efforts create patient demand for the new option. “We need to rein in the technology so that it doesn’t extend beyond where we know it’s beneficial, and where there are knowledge gaps, we have to perform rigorous studies to address them.”
He notes that in the interim, an extensive training experience in a fully proctored environment might be the best approach for mature surgeons to learn new procedures. Hospitals may even see benefit in supporting such training experiences to ensure their surgeons can perform new operations and use new technology safely.
Pradarelli, who is pursuing a master’s degree in clinical research and studying surgical safety during his final year of medical school, works with Dimick and Campbell at the U-M Center for Health Outcomes and Policy.
He notes that some professional societies have started to offer online classes to help residents, fellows and mature surgeons learn new skills, but that these are often basic and likely will not help the credentialing process.
Pradarelli says that efforts to have experienced surgeons review videotapes of surgeons performing procedures, and offer ratings and feedback about their skill level, may also help improve outcomes and reduce variation. Hospitals could potentially use such a system to determine which surgeons to credential for new operations, and which to refer for further training.
Such an approach is used in the bariatric surgery quality improvement effort led by U-M surgeons and funded by Blue Cross Blue Shield of Michigan. Earlier research by a U-M team showed that surgeon ratings in such a system correlated with how well the patients did after surgery.
Reference: JAMA. 2015;313(13):1313-1314. doi:10.1001/jama.2015.1943
Source: University of Michigan Health System