Inadequate da Vinci Robotic Surgery Training May Lead To Serious Injury
Intuitive Surgical Inc. is confronting new allegations that it failed to provide adequate training for physicians using its da Vinci surgical robot, and may have encouraged less training, thereby increasing the risks to patients undergoing robotic surgery.
No strict training guidelines or requirements currently exist that govern a physician use of the robot on a live patient. The amount and depth of training is currently left within the purview of individual doctors and/or hospitals. Undisclosed personnel from Wentworth-Douglass Hospital in Dover, NH, have stated that their training included only two days of operation on a pig and human cadavers.
Intuitive’s chief medical advisor, Myriam Curet stated that, “The training we do is quite extensive,” and according to Intuitive’s website, “We believe rigorous training standards and support of our System users are essential to establishing and maintaining a successful da Vinci Surgery program.” However, Intuitive’s suggested training regimen hardly seems adequate as it only includes an online quiz consisting of 10 hard-to-fail questions, practice simulators and a one-day training course, as well as a minimal number of proctored cases.
Interestingly, prior to the robot being cleared by the FDA in 2009, the online quiz was 70 questions and the training course was three days long. With regards to adequate training, Benjamin O. Anderson, an FDA panel member at the time, stated that it “is the most important part of what was discussed today.”
In response to a recent lawsuit, Intuitive argued that because “credentialing and privileging for performing surgery at a hospital is solely the responsibility of the hospital,” the case should be dismissed. This particular case was subsequently settled. Nonetheless, lawsuits are continuing to be filed in connection with injuries sustained by patients alleging as causative factors inadequately trained doctors using the robot.
Internal Intuitive emails introduced in a lawsuit filed in Kitsap County, Washington have uncovered a manager’s recommendation to a sales team in connection with meeting sales goals, to not “let proctoring or credentialing get in the way.”
Doctors themselves are voicing their opinions about the learning curve of the robot:
- The American Association of Gynecologic Laparoscopists suggests at least 10 supervised surgeries prior to allowing doctors to use the robot unsupervised.
- Dr. Jim Hu, director of Urologic Robotic and Minimally Invasive Surgery at the David Geffen School of Medicine at the University of California, Los Angeles indicates that, “The robot surgery requires a long learning curve to become good at it,” and specifically referring to prostate cancer surgery, Hu says that proficiency can take up to 200 plus operations to achieve. Dr. Hu assisted on 400 robot surgeries prior to performing them on his own. “None of us would go and get surgery if we knew the guy had done it just a couple of time before,” he says.
- According to a recent study conducted by the Mayo Clinic, published in the Obstetrics & Gynecology medical journal, surgical proficiency “occurs after performing approximately 91 procedures.”
Dr. Anne Kalter, a surgeon from Wentworth-Douglass Hospital, a supporter of robotic surgery, has said that in connection with adequate training, “There is no national standard requirement for this…it will probably be coming in the next couple of years. The technology is so new that every hospital has been finding out on its own what path is comfortable for them to take. “ Unfortunately, the path Wentworth-Douglass chose to take obviously was not adequate. During two routine hysterectomies, a physician accidentally cut the ureters of the patients. Subsequently, the physician performing the surgery and the supervising physician were both required to have remedial training.
SOURCES:
http://www.intuitivesurgical.com/training/
http://www.fosters.com/apps/pbcs.dll/article?AID=/20100512/GJNEWS_01/705129914/-1/FOSNEWS
http://online.wsj.com/article/SB10001424052702304703104575173952145907526.html
