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. A RWD robotic surgery registry is being developed that systematically collects in near real-time device-related and process-related data that is interoperable with clinical databases, and utilizes those data to improve device safety, hospital quality improvement efforts, surgeon/team performance, and public health.
“The FDA’s Center for Devices and Radiological Health has identified the development of real-world data collection systems as a strategic priority” according to Dr. Binita Ashar, the Director of the FDA’s Division of Surgical Devices. “Such data has the potential to support premarket regulatory decision-making and to streamline the development of innovative products to help treat patients. Such a registry can serve as a continuous mechanism for monitoring and furthering safe innovation of Robotic-Assisted Surgical Devices (RASD) devices for patient benefit.”
A landmark RASD Registry consensus conference was convened by the Institute of Surgical Excellence in September 2016, which brought together 44 key opinion leaders through a public – private partnership to determine the minimal data set that would be needed for a RASD Registry. The participants included robotic surgery experts, registry experts, government representatives, and society representatives.
Through the consensus conference discussions and two additional post-conference Delphi surveys completed by the meeting participants, a minimal intraoperative and OR staff experience data set was agreed upon that will be included in the RASD Registry. A six-month pilot study is planned in eight hospitals to test the data set, optimize the efficiency of collecting the data, and refine data security measures. Learnings from the pilot study will be incorporated into the data collection work flow and the development of a national RASD Registry that is anticipated to be completed and ready for roll-out in Q1 2020.
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.
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.
Binita Ashar, MD
Martin Martino, MD
Jay Redan, MD