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Robotic Surgery Technology - Dissertation Example

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Robotic surgery devices such as the da Vinci Surgical System represent some of the most innovative advances in medicine today, but the industry presents questions related to medical device regulation that may challenge existing standards by the FDA and other agencies. …
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Download file to see previous pages The most popular of the robotic surgery platforms in healthcare institutions currently is the da Vinci Surgical System produced by Intuitive Surgical (NASDAQ:ISRG). The company Computer Motion was also involved in early innovation in this field, with the production of the ZEUS Robotic Surgical System and AESOP Robotic System. (World Laparoscopy Hospital, 2008) However, Intuitive Surgical acquired Computer Motion, merging the technology of the two companies, and using the advances to improve the da Vinci Surgical System. This dissertation proposal outlines a thesis to investigate the regulatory implications of advances in robotic surgery, including an analysis of FDA and international licensing for these technologies. The research will include a review of current robotic surgery platforms including Intuitive Surgical, and focus on the training, licensing, and certification of professionals in the use of these platforms. Medical research related to the use of robotic surgery will be consolidated into a review of literature, and recommendations for the implementation of this technology in healthcare institutions will be made by the conclusion of the dissertation. Because of the new and rapidly expanding nature of this technology, the dissertation will fulfill the role of directly analyzing the regulatory implications of robotic surgery technologies for medical professionals and healthcare administrators. The da Vinci Surgical System was the first robotic surgery device to be approved by the FDA on July 11th, 2000. “FDA clearance was based on a review of clinical studies of safety and effectiveness submitted by the manufacturer and on the recommendation of the General and Plastic Surgical Devices Panel of FDA's Medical Devices Advisory Committee. Intuitive Surgical studied use of the robotic system on 113 patients who underwent surgery for gall bladder or reflux disease, then compared them to 132 patients who received standard laparoscopic surgery. Results showed that the robotic system was comparable to standard laparoscopic surgery in safety and effectiveness. While the surgical procedures with the robotic device took 40 to 50 minutes longer than standard laparoscopic surgery, this was attributed, in part, to lack of surgical experience with the new technology. Because of the expected learning curve with the new system, Intuitive Surgical is developing a training program for surgeons in collaboration with FDA.” (ScienceDaily, 2000) The dissertation will review both the guidelines implemented by the FDA for robotic surgical technology, as well as the specific training programs advanced by Intuitive Surgical for the certification of teams for use of the da Vinci Surgical System, using these as case studies and relating them to clinical research studies. According to the Washington Post, “In 2010, an estimated 220,000 U.S. procedures were assisted by a robotic device called the da Vinci surgical system.” (Torres, 2011) The extent of use of this technology in medical institutions requires a review of the regulatory requirements regarding licensing, training, and certification for medical ...Download file to see next pagesRead More
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