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Tougher Industry Standards Stressed for Robotic Surgery Centers

Aug 10, 2009

Concerns over patient safety and liability prompt a call for implementation process and credentialing in the rapidly growing field of robotic urological surgery

Contact: Catherine Gianaro
cgianaro@weisshospital.com
(773) 564-7285

CHICAGO (Aug. 10, 2009)—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, M.D., chief of urology at Weiss Memorial Hospital, and assistant professor and co-director 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."

Zorn is a proctor; he has performed more than 500 RARPs. Surgeons at Weiss Memorial Hospital and its affiliated University of Chicago Medical Center have conducted more than 2,500 RUS procedures.

With an estimated 85 percent 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; and
  • Obtaining informed consent from the patient with regards to the role of the proctor during the surgery and thereafter.

The authors see one way of increasing the pool of available proctors to make these guidelines possible through telemedicine technology, which allows an expert surgeon stationed remotely to observe, oversee and actively supervise a procedure being conducted by a surgeon learner at his or her institution. “It not only will enable expert robotic surgeons to easily proctor reducing time and financial considerations,” Zorn said, “but also optimize outcomes and improve safety.”

Bradley Schwartz, M.D., director of the Center for Laparoscopy, Endourology and Robotic Surgery, and professor of urology at Southern Illinois University School of Medicine, wrote an editorial in the Journal of Urology reviewing the article. He sees training and credentialing of surgeons paramount to the success of robotic surgery now and in the future.

“Many urologists feel pressured to keep up [with technology] and offer procedures that may be out of their skill sets, [which] puts the public in harm’s way,” Schwartz said.

“With a persuasive link between patient safety and limited liability with RARPs,” Zorn added, “there is a great need to establish a framework for ensuring the safety of patients and surgeons alike by initiating a robotics program at hospitals across the country.”

Zorn said he hopes the article in the Journal of Urology will serve as a catalyst for organizations to discuss and implement regulatory oversight of surgeon certification and proctorship.

For more information on the SURS recommendations or Weiss Memorial Hospital’s urology program, visit www.weisshospital.com or call (773) 564-5385.