To design, develop, and successfully implement a RWD robotic surgery data registry that systematically collects in near real-time device-related and process-related data, is interoperable with clinical databases, and utilizes those data to improve device safety, surgeon/team performance, and public health.

About the Registry

The new era of information science has resulted in immediate availability, analysis and sharing of real world data (RWD) that is available at the time of the occurrence – at the pace of innovation and change. However, the potential benefit of emerging technologies and innovations are slowed by the continued use of prospective clinical trials, peer-review evaluations, and the submission of research publication, which require rigorous and careful evaluation and prolonged completion time.

One solution that has emerged is the development of ‘registries’-databases which are created in near-real time and which reflect data that is available at the time of occurrence, as opposed to the traditional practice of stored data that is awaiting review and possible publication. Implementing this solution, healthcare professional communities of individual physicians, hospitals, governing bodies and societies, industry, federal agencies, etc can work together using information before it has become obsolete, allowing for real-time analysis and decisions that reflect the current status in the process of dynamic change.

More than 45 medical experts gather at the Robotic Registry Consensus Conference in Orlando, FL.
More than 45 medical experts gather at the Robotic Registry Consensus Conference in Orlando, FL.
A group of experts discuss the top priorities of a robotic registry.
Binita Asher from the FDA speaks at the conference.

Robotic-Assisted Surgical Devices

One example of rapid innovation and transformation is robotic-assisted surgical devices. A real- world-data (RWD) robotic surgery registry would allow:

  • Physicians to evaluate their operative performance for self-improvement
  • Educators to develop standardized training programs and certification processes for ongoing education, remediation, and privileging
  • Hospitals to develop quality measures, effectiveness and risk assessment to trend patient care for quality improvement
  • Industry to assess the performance of their devices to promote more rapid iterations towards improved functionality and safety
  • Government to maintain minimal safety and effectiveness standards and stay informed of new developments that could influence policies

All of these benefits in efficiency and greater accuracy succeed due to the rapid analysis of massive quantities of RWD.

SPECIFIC GOALS

The goal is to create a pilot robotic-assisted surgery registry that:

  • Is open to data collection on all robotic assisted surgical device procedures performed within the US and internationally
  • Collects information on robotic assisted surgical device procedures across all specialties.
  • Collects, analyzes and reports data in near-real time.
  • Collects data for a limited data set of core measurements that have value for
  • distinguishing between device-related malfunctions versus non-device related events.
  • Develops inter-operability by utilizing existing registry structures such as NSQIP and other society registries.
  • Avoids double data entry, physician data entry, and prohibitive additional costs.
  • Serves as a resource and feedback to participating institutions for patient safety, surgeons for self-assessment and self-improvement, industry partners for device tracking and research, payers, and patients in a manner that is timely and that results in improved public health.

When the pilot registry has accomplished the above stated goals, incrementally expand this core database to include other medical devices.