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What Can Go Wrong?

From a regulatory standpoint, the FDA pays close attention to the potential for error and whether robotic equipment meets performance standards, says Ogden. "We evaluate the possibility of technical failure of the computer and whether it translates into any risk for patients."

So far, there haven't been indications that robotic surgery is any riskier than standard laparoscopic procedures. And there haven't been any patient injuries or deaths related to robotic system failures.

Chitwood says there is always a risk of technical difficulty when it comes to automated products. But there are also fail-safe mechanisms that help protect against problems. "[The] da Vinci will make a dinging noise if your head isn't engaged in the right place," he says. "And if it isn't engaged in the right place, then you can't make any movements."

Experts say there may be times when the surgeon will begin a surgical procedure with the robot and then for one reason or another have to abandon it and do the surgery using traditional methods. "But that's not bad," says Vaughn A. Starnes, M.D., Hastings professor and chairman of the department of cardio-thoracic surgery at the Keck School of Medicine, University of Southern California (USC).

"We would just switch if we needed to and go to a conventional surgery," which surgeons say matches the care patients would otherwise receive. "We might get in there and realize the robot can't be used because of anatomical reasons such as if the atrium is too small," says Starnes, who uses da Vinci as part of the multi-center mitral valve study.

Ogden says other important safety-related questions include: How much longer does it take to perform a procedure with robotic assistance? And, is the time difference significant? Studies of da Vinci indicate that surgery using the robotic device took about 50 minutes longer — nearly twice as long as with standard laparoscopic surgery. The increase in length of time is largely attributed to lack of experience with the new technology. "Eventually, we would like to see that the operative times are similar to the standard times," Ogden says.

Massimiano says doctors carefully evaluate whether a patient can take a longer surgery. "We won't use the robot if we believe a patient can't stay on the heart-lung machine for a certain length of time."

The Learning Curve

The FDA requires manufacturers to train surgeons before they can use robotic surgical systems on patients. Ogden says there is a significant learning curve involved. "As it stands now, it takes 12-18 patients before surgeons feel comfortable and before surgeons are able to perform the procedures as quickly as with standard techniques," he says.

Paul Nolan of Computer Motion says typical training for surgeons who buy the ZEUS system involves up to 40 hours, including experience at animal and cadaveric labs. "We believe we presently have a solid surgeon training regime for ZEUS customers, and we are also actively improving the whole training program for our products," Nolan says.

In terms of ZEUS, he says, these improvements include a program covering technical training, operating room choreography, sterility, and enhanced hands-on lab training modules based on a surgeon's endoscopic skill level.

Training involves having surgeons come to the company's headquarters and training at hospitals. The same idea is used for da Vinci, which has four active training centers, according to Gene Nagel, director of training at Intuitive Surgical. The company offers two- and three-day da Vinci training programs based on different surgical specialties.

"Our core focus is team training," Nagel says. "For nurses, it's preparation, intraoperative and postoperative system management. For surgeons, it's training to the necessary skills to become facile in using da Vinci in a variety of surgical applications."

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www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.