Orlando, FL (September 23, 2016) – Experts across the country joined the Institute for Surgical Excellence (ISE) – a non-profit organization created for the purpose of ensuring excellence in surgical safety and training standards for those who utilize cutting-edge surgical technologies – and representatives from the Food and Drug Administration (FDA) for a landmark Robotic Registry Consensus Conference in Orlando. Concluding the two-day conference, nearly 50 experts collectively agreed on the need for a comprehensive national registry of surgical robotic procedures that systematically collects real-time device-related and clinical data. The data will be used for quality improvement of both the device and surgeon performance with the ultimate goal to enhance patient outcomes.
The Robotic Registry Consensus Conference helped to determine what surgical data is necessary to capture and analyze, while preserving patient privacy, and improving patient safety on an ongoing basis. Moreover, the experts at the Conference developed three specific goals for the registry:
• Partner with existing registries to develop a prospective real-time surgical registry to systematically collect intraoperative real world data, which includes events, complications and 90-day outcomes for all cases
• Develop a comprehensive analysis of reported adverse events during and following robotic or computer-assisted surgery to identify device versus non-device errors
• Manage surveillance of overall clinical outcomes for surgical care and provide real-time feedback
”Having experts from across the country join us with such a strong commitment and passion to develop a Robotic Registry helped make the consensus conference a true success. It was amazing how much was accomplished in such a short period of time through dynamic discussions between a diverse group of experts representing robotic surgeons, a variety of registries, the FDA, MDEpiNet, surgical societies and industry,” said Jeffry Levy, Executive Director of ISE.
ISE was joined at the conference by representatives from Intuitive Surgical, Stryker, Medtronic/ Covidien, J&J /Verb Surgical, Transenterix, Medrobotics Corporation, Medicaroid and Titan Medical Inc. Participating companies were invited given their expertise in the field and commercial availability of an FDA approved or emerging robotic surgery systems. Representatives from surgical specialty societies attended the conference to offer their expertise for determining the most appropriate structure and outcome measures for the registry. The societies who attended included American College of Obstetricians and Gynecologists, American College of Surgeons, American Society of Colon & Rectal Surgeons, American Urological Association, Society of American Gastrointestinal & Endoscopic Surgeons, Society of Gynecologic Oncologists, Society of Gynecologic Surgeons, and the Society of Laparoendoscopic Surgeons.