FDA releases final report on da Vinci

"The U.S. Food and Drug Administration (FDA) has issued a Final Report of findings gathered through a survey of surgeons throughout the United States who have used the da Vinci Surgical Robot in various medical procedures. The survey was conducted by the FDA, “to better understand [surgeon] perspectives on the different challenges raised when using the system interface to perform surgery versus using conventional surgical procedures.”

In receiving survey responses from eleven da Vinci robot surgeons, most from hospitals with a bed size of 100 or more, the FDA Report highlighted the following suggestions:

1. All survey respondents reported a need to perform multiple surgeries before feeling fully proficient in using the da Vinci surgical system;
2. That additional dry lab testing be offered and/or provided;
3. That pre-surgery training consist of a mandated threshold of hours.

While the FDA’s investigation into design problems continues, the FDA’s Report suggests that inconsistent surgeon training, or lack thereof, may be another problem in causing patient injuries. Jeff Berkley, chief executive of Mimic Technologies Inc., which makes robotic surgery simulators for training purposes, told Bloomberg, “[t]raining for robotics has been the wild, wild west for a long time,” and that hospitals and doctors realize, “they have to get their act together and start focusing on training.”
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