Surgeon Survey: Robotic Surgery Requires Training, Practice, Careful Patient Selection
The FDA released results last month of a small survey it conducted of surgeons who have used the da Vinci Robotic Surgical System. The survey brought to light the importance of thorough training and lots of practice before surgeons are comfortable using the complicated robotic equipment. It also underscored the importance of identifying patients who are good candidates for robotic surgery.
The da Vinci system uses robotic arms to micro-manipulate laparoscopically inserted surgical instruments. It is the only robotic system for general surgery approved for use in the U.S. It is manufactured by Intuitive Surgical, Inc., of California. About 2,000 da Vinci systems are in use across the country, and they were used in about 500,000 surgeries during 2013.
According to Medscape, an online news service of WebMD, the FDA launched the survey after it saw a “spike” in adverse event reports submitted to the FDA regarding use of the robotic system. The FDA sent out its survey questionnaires in January 2013. Meanwhile, during the first ten months of this year, the FDA has received an additional 3,697 adverse reports regarding da Vinci robotic surgery, which is twice the number of reports in 2012. The reports include severed nerves, severed blood vessels, punctured bladders and electrical burns.
Only 11 surgeons participated in the FDA survey; the FDA said the survey size was not unusual. Responding surgeons, who are located throughout the country, included obstetricians/gynecologists, otolaryngologists, urologists and one cardio-thoracic surgeon. Each surgeon had performed from 70 to 600 surgeries with the da Vinci system during 2009 to 2011.
• Big Learning Curve: One of the most significant responses of the survey is how difficult the robotic surgery system is to master. All 11 respondents said it took them scores of surgeries before they felt proficient using the system. All respondents also said the device’s complex user interface presented a challenge. The interface includes foot pedals and getting comfortable with hand-eye coordination, since the surgeon’s hands are not touching the tissues or organs upon which they are operating.
• Gaining Experience: The big learning curve points to the importance of gaining experience using the device. One respondent said he/she did not feel proficient on the system until after performing 40 to 50 procedures. That’s on-the-job training with 40 to 50 real patients.
Cardiothoracic surgeons may face the greatest challenge because most have never performed laparoscopic procedures. The sole cardiothoracic surgeon responding to the FDA survey said that it took more than 100 surgeries before he/she felt comfortable with the system.
Are there ways to gain experience that do not involve practicing on human patients? Responding surgeons mentioned dry lab training, training on a simulator and practice with dogs, pigs and/or cadavers.
• Training: Some but not all respondents said the manufacturer, Intuitive Surgical, had encouraged them to participate in training. Most respondents indicated the nature and amount of training they received was entirely up to them.
The manufacturer offers training online and provides a certificate of completion to surgeons who work through the 3- to 8-hour online course. One responding surgeon who had considerable laparoscopy experience said the only training he/she received on the da Vinci system was the online course.
According to one respondent, the American Urological Association has developed standardized training and credentialing for the da Vinci Surgical System.
• Patient Selection: All of the surgeons also responded that patient selection is an important factor in the outcome of robotic surgeries.
For more information about da Vinci robotic surgery and for more information about your legal rights if you or a loved one who experienced adverse effects in robotic surgery, see our webpage: “Robotic Surgery Lawsuits Claim Injuries, Deaths Caused by Use of Device.”
The FDA’s 16-page survey results are available on the FDA website.