Robotic Surgery Technology - Dissertation Example

? Robotic Surgery Technology: Regulatory Requirements for International Medical Licensing, Healthcare Applications, and Clinical Use : Table of Contents Table of Contents 0 Abstract 1 Introduction 2 Review of Previous Research 4 Research Methodology 7 Reflections 9 Conclusion 11 Timetable 12 References 13 Appendix 17 Abstract 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. This dissertation will review the leading companies, products, and research related to robotic surgery devices, including medical licensing for use, training, and clinical testing related to the technologies. Introduction The da Vinci Surgical System for Robotic Surgery – (Image: Intuitive Surgical, 2011) 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 professionals to use these devices in healthcare institutions. Review of Previous Research The most important and comprehensive scientific study published thus far relating to the use, licensing, training, and certification of medical professionals for use of robotic surgical devices is “A Consensus Document on Robotic Surgery” published by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). This study included over 20 of the leading researchers in robotic surgery, including the two research coordinators, Daniel M. Herron of Mount Sinai School of Medicine and Michael Marohn of the Johns Hopkins School of Medicine’s Department of Surgery. (Herron & Marohn, 2007) This study can be considered a reference document for robotic-assisted surgery in the early 21st Century, and contains a bibliography of approximately one hundred of the most important clinical trials and experiments related to robotic surgery. (Herron & Marohn, 2007) This study defined robotic surgery as that which “refers to surgical technology that places a computer-assisted electromechanical device in the path between the surgeon and the patient... we define robotic surgery as a surgical procedure or technology that adds a computer technology enhanced device to the interaction between a surgeon and a patient during a surgical operation and assumes some degree of control heretofore completely reserved for the surgeon.” (Herron & Marohn, 2007) This study is extensive and for the purposes of the dissertation, a thorough review of the recommendations of the SAGES committee will be analyzed. In the Appendix of this dissertation proposal, the recommendations of the SAGES committee for the licensing, regulation, and training of healthcare professionals in the use of robotic surgery devices are reprinted for reference. (See: Appendix) In summary, these recommendations suggest that as a fundamental guideline, “surgeon(s) must have the judgment and training to safely complete the procedure as intended, as well as have the capability of immediately proceeding to an alternative therapy when circumstances so indicate” (Herron & Marohn, 2007) The guidelines in the Appendix establish a set of rules relating to the regulation of training, licensing, and certification for medical professionals using robotic surgery technology. The dissertation as proposed will also review the major medical literature related to robotic surgery in order to establish the range of usage in healthcare, and additionally examine some of the main platforms for robotic surgery such as the da Vinci and offerings from other companies such as Toshiba, Hitachi, etc. While the review of the robotic surgery industry will provide an overview approach to the emerging sector, the dissertation will focus on the regulation, certification, training programs, and licensing for these technologies that are required. A case study will be made of the training program for the da Vinci Surgery System that involves a team approach rather than individual licensing. As team training involves different dynamics for the industry and also professionals working in healthcare, these issues will be developed in the dissertation discussion. The training path advocated by Intuitive Surgical for the da Vinci system can be seen below: Surgeon and Team Pathways – (Intuitive Surgical, 2011) The dissertation will examine the da Vinci Surgical System team pathway as a case study of requirements in training that healthcare institutions interested in implementing these technologies will have to consider in developing a robotic surgery program at a hospital, clinic, or other facility. Research Methodology An outline of the research methodology for the dissertation is listed below: 1. Review of Leading Manufacturers of Robotic Surgery Technology 2. Establishing the International Regulatory Framework 3. Current Regulatory Framework for Robotic Surgery Devices in the U.S., EU, & internationally. 4. Clinical Testing related to Robotic Surgery Devices – Literature Review 5. Medical Training Requirements for Licensed Use of Robotic Surgery Devices 6. Recommendations for Training, Licensing, and Use in Healthcare Institutions The dissertation will include an overview of the main platforms related to robotic-assisted surgery, and relate the popularity of the da Vinci system to other companies in the sector. A brief overview of the international regulatory system for medical technology will be used to show how this applies to robotic surgery technology in each region globally. The FDA regulations, the academic guidelines proposed in “A Consensus Document on Robotic Surgery” (Herron & Marohn, 2007), and the training guidelines for the da Vinci Surgical System will be used as case studies to build consensus and understanding in the research. The clinical testing related to medical research in robotic-assisted surgery will be reviewed in studies such as: “A prospective analysis of 211 robotic-assisted surgical procedures,” (Talamini et al, 2003) “Robotic technology in surgery: past, present, and future,” (Camarillo, 2004) “Assessment of intraoperative safety in transoral robotic surgery,” (Hockstein, 2006) “FDA Regulation of Technology and Surgical Devices in the Operating Room,” (Ogden, 2003) “The World Wide Web and Robotic Heart Surgery,” (Semer, 2003) The major goals of the research can be summarized as: 1. International Review of Medical Device Regulations 2. Policy Review Related to Robotic Surgery Devices 3. Review of Medical Literature 4. Criticisms of Robotic Surgery & Potential Dangers The application of regulation to robotic technology in medicine will be examined through the FDA regulations and academic standards, while the effects of this in global healthcare policy will be assessed. The review of medical literature will include studies such as those listed above, selected according to an inclusion criteria related to the research methodology. A summary of recent criticisms was reported by CNN, suggesting that the cost of robotic surgery may currently be unjustified, or that the benefits of these methods may not be overly different from traditional surgery. As CNN reported, “The Korea Times reported yesterday, however, that top Korean hospitals are exaggerating the benefits of robotic surgery, with no evidence that it is superior to surgery performed by humans, despite being six times more expensive... Earlier this year, The New York Times published an article suggesting that robotic surgery may be more in line with the marketing goals of hospitals than with scientifically documented benefits.” (Cha, 2011) The research methodology should include a discussion of these criticisms, as well as potential dangers for patients, physicians, or institutions committing professionally to these platforms. Reflections The da Vinci Surgical System and other robotic devices may represent a significant trend in the future of healthcare, displacing traditional surgical techniques because of the ability to perform the same services with minimally invasive devices. There is not unanimity of agreement currently in the total superiority of these methods over traditional surgery performed by hand, but the spread of robotic surgery devices internationally into healthcare institutions seems likely to continue to expand, changing the need for training and licensing with these technologies. The FDA has established preliminary guidelines for regulating the use of robotic equipment in healthcare institutions, and the dissertation proposed will analyze these regulations in comparison to the advanced guidelines established in the report, “A Consensus Document on Robotic Surgery” published by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). (Herron & Marohn, 2007) The dissertation will consider the use of robotics in tele-surgery, where remote operations and surgery at a distance is made possible by technological intermediation. The dissertation will not look into the regulation of robotic limbs and prosthetics in medicine. The research for the dissertation will be strictly limited to robotic surgical devices and the regulation, training, licensing, and certification procedures related to the use of this technology by medical professionals. Companies like Intuitive Surgical have also developed training, licensing, and certification for their products related to robotic surgery. The dissertation will examine the components of these programs, and compare them to current practice in hospitals. The understanding of the differences between licensing and regulation requirements between the USA, the EU, Japan, Australia, and other regions will be noted in relation to the academic proposals to standardize these regulations according to scientific consensus. The FDA guidelines and training related to the da Vinci Surgical System will be taken as case studies for the industry. Industry analysis of robotic surgery platforms as well as clinical research related to the medical use of robotics in surgery will be included through reviews of scientific literature from peer-reviewed journals. The dissertation will include recommendations for implementing a robotic surgery department in a healthcare facility as an example of building local policy in institutions through the implementation of the consensus in medical standards related to the regulation, licensing, training, and certification for use of robotic surgery devices healthcare professionals. These recommendations should include specifics for doctors, surgeons, nurses, and support staff. The application of the research from the dissertation would be for healthcare professionals to clearly understand the regulations relating to training, licensing, and certification for the use of robotic surgery devices internationally. In addition to this, healthcare administers would find the research from the dissertation valuable in implementing policy at local institutions, or in researching the costs and requirements of adding robotic surgery technologies to their facilities. Nurses, technicians, and other support personnel would be able to reference the research from the dissertation under Evidence Based Practice (EBP) studies when seeking certification for robotic surgery platforms like the da Vinci Surgery System. In providing a consolidated review of literature in relation to robotic surgery platforms, the research related to their use in medicine, and also the FDA regulation related to their use in healthcare institutions, the dissertation will provide a balanced study of the topic with an extensive bibliography for further reading. This type of research is needed particularly for robotic surgery technology because it is such a new and quickly expanding field where many healthcare professionals may benefit for re-training in this field. Conclusion Because of the rapid expansion of the use of robotic surgery devices in healthcare through the popularity of the da Vinci system, the future of medicine can be seen to be changing in the direction of these tools in the future, due to the precision and minimal invasion to the human body they offer surgeons in providing critical solutions for patients. The advanced technologies require new training for teams, and the cost of these systems requires a certainty with regard to their use, advantages/disadvantages, and safety. Because of this, there is also an existing need to regulate this equipment through FDA standards and scientific guidelines internationally. The dissertation as proposed will examine these issues in depth, providing a research report which will be of interest to medical professionals and healthcare administrators. As this technology has primarily advanced in the 21st Century, a review of breakthroughs in the field and their impact in changing practice is related to a broader understanding of the future of the healthcare industry, as well as the specialized field of robotic-assisted surgery. Timetable The dissertation proposal shall be submitted at the end of July, 2011 to the advisor for approval. Following formal approval of the project, I will continue the research that I have already gathered related to this topic and hope to complete the research before the end of the summer semester on November 30st, 2011. In completing the dissertation research, I would like to continue to work in this area of robotic surgery technology as a professional in hospital administration. References Ballantyne, Garth H.; Marescaux, Jacques; Giulianotti, Pier Cristoforo 2004, Primer of robotic & telerobotic surgery, Lippincott Williams & Wilkins, 2004, viewed 27 July 2011, http://books.google.co.in/books?id=mxHYzjXFywwC Burgera, Thomas; Laiblea, Ulrich; and Pritschowa, Gunter 2001, Design and Test of a Safe Numerical Control for Robotic Surgery, CIRP Annals - Manufacturing Technology, Volume 50, Issue 1, 2001, Pages 295-298, viewed 27 July 2011, http://www.sciencedirect.com/science/article/pii/S0007850607621258 Camarillo DB, Krummel TM, Salisbury JK Jr. 2004, Robotic technology in surgery: past, present, and future, Am J Surg. 2004 Oct;188(4A Suppl):2S-15S, viewed 27 July 2011, http://www.ncbi.nlm.nih.gov/pubmed/15476646/ Cha, Frances 2011, Benefits of robotic surgery exaggerated, critics say, CNN, 13 July, 2011, viewed 27 July 2011, http://www.cnngo.com/seoul/life/benefits-robot-surgery-exaggerated-critics-say-350439 Chamberlain Group, The 2008, Chamberlain Group Announces Two New Robotic Surgery Training Devices, The Chamberlain Group Great, Barrington, MA, November 6, 2008, viewed 27 July 2011, http://www.thecgroup.com/press/items/chamberlain-group-announces-two-new-robotic-surgery-training-devices De Ugarte, Etzioni, Gracia, & Atkinson 2003, Robotic surgery and resident training, Surg Endosc. 2003 Jun;17(6), pp. 960-3. Epub 2003 Mar 28, viewed 27 July 2011, http://www.ncbi.nlm.nih.gov/pubmed/12658424 Eisner, Robin 2011, FDA OKs First Robotic Surgical Device, ABC News, July 13, 2011, viewed 27 July 2011, http://abcnews.go.com/Health/story?id=118152&page=1 Food And Drug Administration 2000, FDA Approves New Robotic Surgery Device. ScienceDaily, viewed July 27, 2011, http://www.sciencedaily.com­ /releases/2000/07/000717072719.htm Herron, Daniel M.; Marohn, Michael; et al. 2007, A Consensus Document on Robotic Surgery, Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), 11/2007, viewed 27 July 2011, http://www.sages.org/publication/id/ROBOT/ Hockstein NG, O'Malley BW Jr, Weinstein GS 2004, Assessment of intraoperative safety in transoral robotic surgery, Laryngoscope. 2006 Feb;116(2), pp. 165-8, viewed 27 July 2011, http://www.ncbi.nlm.nih.gov/pubmed/16467698 Intuitive Surgical 2010, The da Vinci Surgical System, Intuitive Surgical, Web, viewed 27 July 2011, http://www.intuitivesurgical.com/products/davinci_surgical_system/ Johns Hopkins University 2006, Robotic Surgery Technology Gives Doctors 'Sense Of Touch'. ScienceDaily, viewed 27 July 2011, http://www.sciencedaily.com­ /releases/2006/11/061128121916.htm Kolata, Gina 2010, Results Unproven, Robotic Surgery Wins Converts, The Washington Post, February 13, 2010, viewed 27 July 2011, http://www.nytimes.com/2010/02/14/health/14robot.html Lanfranco, Anthony R.; Castellanos, Andres E.; Desai, Jaydev P.; and Meyers, William C. 2004, Robotic Surgery - A Current Perspective, Ann Surg. 2004 January; 239(1), pp. 14–21, viewed 27 July 2011, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1356187/ Lysaght et al. 2005, Robotic surgery extends its reach in health care, hospital marketing, Robotic Surgery Research Website, Brown University, BI 108 Organ Replacement, 2005, viewed 27 July 2011, http://biomed.brown.edu/Courses/BI108/BI108_2005_Groups/04/ Mack, Michael J. MD 2010, Minimally Invasive and Robotic Surgery, JAMA. 2001;285(5), pp. 568-572, viewed 27 July 2011, http://jama.ama-assn.org/content/285/5/568.short McLean T 2003, The complexity of litigation associated with robotic surgery and cybersurgery, Int J Med Robot. 2007 Mar;3:23-9, viewed 27 July 2011, http://www.ncbi.nlm.nih.gov/pubmed/17441022 Ogden, Neil MS 2003, FDA Regulation of Technology and Surgical Devices in the Operating Room, SURG INNOV September 2003 vol. 10 no. 3, pp. 115-119, viewed 27 July 2011, http://sri.sagepub.com/content/10/3/115.short Semere, Wagahta G; Edwards, Teresa M.; Boyd, Douglas; Barsoumian, Raffi; Murero, Monica; Donias, Harry W.; Karamanoukia, Hratch L. 2003, The World Wide Web and Robotic Heart Surgery, The Heart Surgery Forum, Volume 6, Number 6 / December 2003, viewed 27 July 2011, http://cardenjennings.metapress.com/app/home/contribution.asp?referrer=parent&backto=issue,9,25;journal,57,62;linkingpublicationresults,1:112496,1 Shih, Albert J. 2008, Biomedical Manufacturing: A New Frontier of Manufacturing Research, J. Manuf. Sci. Eng., April 2008, Volume 130, Issue 2, 8 pages, viewed 27 July 2011, http://scitation.aip.org/getabs/servlet/GetabsServlet?prog=normal&id=JMSEFK000130000002021009000001 Talamini, M. A;. Chapman, S.; Horgan, S.; Melvin, W. S. 2003, A prospective analysis of 211 robotic-assisted surgical procedures, Surg Endosc (2003) 17, pp. 1521–1524, Mar 28, viewed 27 July 2011, http://medinfo.ucsd.edu/NR/rdonlyres/E3CAC626-C670-4061-8D7D-6ABAA92E864A/0/Aprospectiveanalysisof211roboticassistedsurgicalprocedures_1003.pdf Taylor, Russell H. 2002, Computer-Integrated Surgery, NSF Engineering Research Center for Computer-Integrated Surgical Systems and Technology, CISST ERC, 2002, viewed 27 July 2011, http://www.cs.jhu.edu/~cis/cista/445/Lectures/Lec1-CIS-2002.pdf Torres, Christian 2011, Robotic surgery extends its reach in health care, hospital marketing, The Washington Post, July 19, 2011, viewed 27 July 2011, http://www.washingtonpost.com/national/robotic-surgery-extends-its-reach-in-health-care-hospital-marketing/2011/06/15/gIQAnw6HMI_story.html U.S. Department of Health and Human Services 2000, FDA APPROVES NEW ROBOTIC SURGERY DEVICE, Office of Public Affairs, 2000-JUL-12, Science Blog, 2004, viewed 27 July 2011, http://www.scienceblog.com/community/older/archives/M/2/fda1238.htm World Laparoscopy Hospital 2008, Minimal Access Robotic Surgery, Delhi Laparoscopy Hospital Pvt. Ltd., November 2nd 2008, viewed 27 July 2011, http://www.laparoscopyhospital.com/minimal_access_robotic_surgery.htm Appendix The Appendix includes a copy of standards proposed for professional medical licensing in “A Consensus Document on Robotic Surgery” (Herron & Marohn, 2007). These guidelines concern the standardization of training, licensing, and regulation of robotic surgery devices in healthcare facilities internationally under a standardized set of rules. These guidelines were published in a study with over 20 of the top medical experts in robotic surgery. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES): Daniel M. Herron, Department of Surgery, Mount Sinai School of Medicine Michael Marohn, Johns Hopkins School of Medicine, Department of Surgery The SAGES-MIRA Robotic Surgery Consensus Group: Arnold Advincula MD, University of Michigan Medical Center, Ann Arbor, MI, USA Sandeep Aggarwal MD, Mount Sinai School of Medicine, New York, NY USA Tim Broderick MD, University of Cincinnati College of Medicine, Cincinnati, OH USA Ivo Broeders MD, University Medical Centre Utrecht, Heidelberglaan, Netherlands Arnold Byer MD, Hackensack University Medical Center, Wyckoff, NJ, USA Myriam Curet MD, Standford Medical Center, Stanford, CA, USA David Earle MD, Baystate Medical Center, Springfield, MA, USA Piero Giulianotti MD, Misericordia Hospital, Grossero, Italy Warren Grundfest MD, University of California Los Angeles, Los Angeles, CA, USA Makoto Hashizume MD, Kyushu University, Fukuoka, Japan William Kelley MD, Henrice Doctors Hospital, Richmond, VA, USA David Lee MD; Presbyterian Medical Center, Philadelphia, PA, USA Elspeth McDougall MD, University of California Irvine Medical Center, Orange, CA, USA John Meehan MD, University of Iowa Hospital, Iowa City, IA, USA Scott Melvin MD, Ohio State Unviversity Hospital, Columbus, OH, USA Mani Menon MD; Henry Ford Hospital, Detroit, MI, USA Dmitry Oleynikov MD, Nebraska Medical Center, Omaha, NE, USA Michael Palese MD, Mount Sinai School of Medicine, New York, NY, USA Vapul Patel MD, Ohio State Unviversity Medical Center, Columbus, OH, USA Rick Satava MD, University of Washington Medical Center, Seattle, WA, USA Steven Schwaitzberg MD, Cambridge Health Alliance, Cambridge, MA, USA Gregory Weinstein MD, Presbyterian Medical Center, Philadelphia, PA, USA Appendix I: Guidelines for Institutions Granting Privileges in Therapeutic Robotic Procedures Preamble The International consensus group of 2006 of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the Minimally Invasive Robotic Association (MIRA) recommend the following guidelines for privileging qualified surgeons in the performance of surgical procedures utilizing therapeutic robotic surgical devices alone or in a hybrid fashion. The basic premise is that the surgeon(s) must have the judgment and training to safely complete the procedure as intended, as well as have the capability of immediately proceeding to an alternative therapy when circumstances so indicate. I. Principles of Privileging A. Purpose The purpose of this statement is to outline principles and provide practical suggestions to assist healthcare institutions when granting privileges to perform procedures utilizing these technologies. In conjunction with other organizations guidelines for granting hospital privileges, implementation of these methods should help hospital staffs ensure that surgery is performed in a manner assuring high quality patient care and proper procedure utilization. B. Uniformity of Standards Uniform standards should be developed which apply to all medical staff requesting privileges to perform procedures utilizing these technologies. Criteria must be established which are medically sound, but not unreasonably stringent, and which are universally applicable to all those wishing to obtain privileges. The goal must be the delivery of high quality patient care. Surgical proficiency should be assessed for every surgeon, and privileges should not be granted or denied solely based on the number of procedures performed. Ongoing review of results and comparison to published data and/or recognized benchmarks is encouraged. C. Responsibility for Privileging The privileging structure and process remain the responsibility of the institution at which privileges are being sought. It should be the responsibility of the specialty department, through its chief to recommend privileges for individual surgeons to perform procedures. These recommendations should then be approved by the appropriate institutional committee, board, or governing body. D. Definitions Must/Shall - Mandatory recommendation Should - Highly desirable recommendation May/Could - Optional recommendation; alternatives may be appropriate Documented Training and Experience 1. Case list that must specify the applicant’s role (primary surgeon, co-surgeon, first assistant, chief resident, junior resident or observer). Complications, outcomes, and conversion to traditional techniques should be included if known. The applicant must specify if these details are not known. 2. Summary letter from preceptor and/or program director and/or chief of service (should state if applicant can independently and competently perform the procedure in question). Privileging - The process whereby a specific scope and content of patient care services (that is, clinical privileges) are authorized for a health care practitioner by a health care organization based on evaluation of the individual’s credentials and performance. Competence or Competency - A determination of an individual’s capability to perform up to defined expectations. Credentials - Documented evidence of licensure, education, training, experience, or other qualifications. Complete Procedural Conduct - Competency of the applicant and/or institution regarding patient selection, peri-procedural care, conduct of the operation, technical skill and equipment necessary to safely complete a procedure and the ability to proceed immediately with the traditional open procedure. Formal Course - A formal course alone is not appropriate training to begin performing a procedure independently. The course should be taught by instructors with appropriate clinical experience, and have a curriculum that includes didactic instruction as well as hands on experience utilizing inanimate and/or animate models. The course director and/or instructor should provide a written assessment of the participant’s mastery of course objectives. Documentation for certain courses consisting of only didactic instruction may consist of verification of attendance. Therapeutic Robotic Procedures - The spectrum of procedures utilizing a human controlled computer assisted electromechanical system which converts information to targeted therapeutic action. II. Minimum Requirements for Granting Privileges Part II A is mandatory, and must be accompanied by either part II B, or II C and at least one component of II D. A. Formal Specialty Training Prerequisite training must include satisfactory completion of an accredited surgical residency program, with subsequent certification by the applicable specialty board or an equivalent as required by the institution. B. Formal Training in Residency and/or Fellowship Programs For surgeons who successfully completed a residency and/or fellowship program that incorporated a structured curriculum in minimal access procedures and therapeutic robotic devices and their use. This should also include the science and the techniques of access to the body cavity and area of surgery. This includes adequate clinical experience. The applicant’s program director, and if desired other faculty members, should supply the appropriate documentation of training and clinical experience. C. No Formal Residency Training in Therapeutic Robotic Surgery For those surgeons without residency and/or fellowship training which included structured experience in therapeutic robotic procedures, or without documented prior experience in these areas, a structured training curriculum is required. The curriculum should be defined by the institution, and should include a structured program. The curriculum should include didactic education on the specific technology and an educational program for the specialty specific approach to the organ systems. If the access is an intracavitary procedure then that experience and education should be a prerequisite to the training. Hands-on training, which includes experience with the device in a dry lab environment as well as a specialty-specific model which may include animate, cadaveric and /or virtual reality and simulation modeling, is necessary. Observation of live case(s) should be considered mandatory as well. Other teaching aids may include video review and interactive computer programs. D. Practical Experience 1. Applicant’s Experience – Documented experience that includes an appropriate volume of cases with satisfactory outcomes, equivalent to the procedure in question in terms of complexity. The chief of service should determine the appropriateness of this experience. 2. Initial clinical experience on the specific procedure must be undertaken under the review of an expert and may include assisting. An adequate number of cases to allow proficient completion of the procedure should be performed with this expert review. 3. Preceptor or proctor. - The specific role and qualifications of the expert must be determined by the institution. Criteria of competency for each procedure should be established in advance, and should include evaluation of: familiarity with instrumentation and equipment, competence in their use, appropriateness of patient selection, clarity of dissection, safety, and successful completion of the procedure. The criteria should be established by the chief of service in conjunction with the specific specialty chief where appropriate. It is essential that mentoring be provided in an unbiased, confidential, and objective manner. E. Formal Assessment of Competency When available, validated measures of competency should be used to further document the applicant's abilities. These may include knowledge, medical decision making, and/or technical skill assessments. This may include certificates of completion of training or validated assessment tools for competency or proficiency in a specific procedure, or set of similar procedures. III. Institutional Support It is necessary that the staff and technical support team undergo a similar formal technical training with the device before its use in a clinical scenario. Therapeutic robotic surgery requires technical support and must be approached with a team concept. IV. Maintenance of Privileges A. Provisional Privileges Once competence has been determined, a period of provisional privileges may be appropriate. The time frame and/or number of cases during this period should be determined by the chief of service and/or the appropriate institutional committee, board, or governing body. B. Monitoring of Performance Once privileges have been granted, performance should be monitored through existing quality assurance mechanisms at the institution. These mechanisms may be modified as appropriate, and should evaluate outcomes, as well as competency in the complete patient care process. C. Continuing Medical Education Continuing medical education related to the field should be required as part of the periodic renewal of privileges. Attendance at appropriate local, national or international meetings and courses is encouraged. D. Renewal An appropriate level of continuing clinical activity should be required. This should include review of quality assurance data, as well as appropriate CME activity, in addition to existing mechanisms at the institution designed for this purpose. E. Denial of Privileges Institutions denying, withdrawing, or restricting privileges should have an appropriate mechanism for appeal in place. The procedural details of this should be developed by the institution, and must satisfy the institution’s bylaws and institutional recommendations. Appendix II. Guidelines for Training in Therapeutic Robotic Procedures Purpose: To define guidelines for practical education in therapeutic robotics and its application to surgical specialties. A defined course should provide the necessary information, skill training and familiarization with the technology to initiate a mentored clinical experience. The completion of a course should be considered only as preparation for the performance of a mentored clinical experience as determined by individual institutions Expert Instructor: Must have substantial practical experience with the specific advanced technology and have utilized this technology in clinical applications with reported results and review. The individuals should have specialty specific experience and expertise in the advanced technology. Didactics: The length of this portion of the educational experience should reflect the complexity of the technology and the specialty specific procedure and the underlying experience of the students, as well as the incremental increase in the procedure and technology. This should allow a complete understanding of the technology, device function, altered functional status, basic troubleshooting, other technical issues, device parameters and limitations. Technology and team interactions should be addressed as well. Procedure specific information should include indications, workup patient selection, instrumentation, preop preparation, patient and system positioning, port placement, procedural steps, complications and management. Learning curve related issues should be presented. Reported outcomes and expected perioperative course should be included. Live Case Observation: The observation of a complete procedure is an important part of a total preclinical training program. The experience should include procedure preparation, system set up, patient positioning, review of case selection and intraoperative technical aspects. Hands on experience: Hands on experience should include non clinical simulation encompassing system set up, connections, operation, and troubleshooting. Initial skill training should include basic and advanced techniques to develop adequate proficiency necessary to complete the intended procedure. Clinical simulation should include procedure specific modeling with successful completion of the key components utilizing an appropriate model for the expected procedures. It is recommended that advanced simulation tools be used when available. The complexity of the procedure may dictate the length of the time necessary to complete the tasks. Residency programs: It is recommended that specialty training programs include exposure to therapeutic robotic interventions as part of their curriculum. A structured curriculum on therapeutic robotic procedures should be included in programs providing clinical experience to their trainees. Source: (Herron & Marohn, 2007). Read More