Tougher Industry Standards Stressed for Robotic Surgery Centers
Concerns over patient safety and liability prompt a call for implementation process and credentialing in the rapidly growing field of robotic urological surgery
(8/12/2009)
Posted by: Chris Gaerig, Associate Editor
Despite a hurried rise in robotic urological surgery in the past 10 years as hospitals try to stay competitive in offering patients the latest technology, no standardized training or credentialing process is in place to test surgeon competency and safety with the da Vinci Robotic Surgical System, leaving many patients and medical centers at risk for error and injury. An article published in the September issue of the Journal of Urology recommends guidelines to safely implement robot-assisted radical prostatectomy (RARP), or robotic prostate cancer removal surgery.
“Proper standards are needed to uphold patient safety and the welfare of surgeons and proctors,” said Kevin Zorn, MD, chief of urology at Weiss Memorial Hospital, and assistant professor and codirector of the Minimally Invasive UroOncology Fellowship Program at the University of Chicago Medical Center, who is lead author of the article, “Training, Credentialing, Proctoring and Medicolegal Risks of Robotic Urological Surgery: Recommendations of the Society of Urologic Robotic Surgeons.”
According to the authors, two distinct forms of supervision need to be regulated during the learning curve period: proctoring, the observation and assessment by a more experienced surgeon of the novice surgeon; and preceptoring, an active, hands-on approach where the experienced surgeon assists a less experienced surgeon in new skills.
“There is no current governing system to assess and approve expert robotic surgeons for proctoring or preceptoring,” Zorn said. Currently, after performing only 20 RARPs or robotic urologic surgery (RUS) procedures, a surgeon is considered proctor eligible. “This heterogeneous pool of robotic experts is far from ideal for ensuring trainee competency.”
With an estimated 85% of all radical prostatectomies this year being performed robotically (more than double the number from just three years ago) and an estimated two new medical centers implementing a robot every week, the Society of Urologic Robotic Surgeons (SURS) suggests 11 parameters to assist hospitals and physicians to ensure safety and competence in credentialing surgeons. They include:
Establishing a national certification authority that would institute and uphold standards for safe introduction of RARP and file follow-up reports to an institutional credentialing committee
Credentialing of institutions and individuals based on standards, including specific training, certification courses, departmental staffing and infrastructure
Increasing the number of regional centers to assist with preceptoring through mini-residency programs
Indemnifying the proctor against any possible legal implications while performing proctoring services for RARP
Obtaining informed consent from the patient with regards to the role of the proctor during the surgery and thereafter