Following the recommendations of the National Medical Device Registry Task Force, a number of strategically Coordinated Registry Networks (CRNs) and other data networks (virtual CRNs) have been rapidly developing into important data sources for the NEST Coordinating Center (NESTcc). Existing and nascent CRNs require support in a number of areas. Currently, there is no organized approach to deploying expertise to develop CRNs and support maturation of existing CRNs. There is also a need to develop “best practices guide,” or repository of methods and approaches.
At the 2017 MDEpiNet Annual Meeting held on October 19th-20th, MDEpiNet began work towards creation of a National CRN Community of Practice to speed the development and advancement of CRNs. Over ten CRNs participated in the meeting, documenting their success stories, lessons learned which helped to elucidate common organizational themes and needs for development. Breakout sessions addressed various aspects of CRN development and made recommendations towards creating the Community of Practice (COP).
The NESTcc and MDEpiNet community recognizes the value that CRNs contribute as a real-world data source, and thus endorses MDEpiNet in its efforts to create a Community of Practice. This draft charter for the CRN COP will be shared with MDEpiNet Executive Committee members for comments and feedback.
Currently, there are fourteen CRNs operating or under development, including the following:
- Robotic CRN
- Core Abdominal Health CRN
- Women’s Health CRN
- VISION Vascular CRN
- Orthopedic CRN
- SPARED (prostate ablation)
- NBIR (breast implant) CRN
- DAISI Neuro CRN
- TMJ CRN
- VANGUARD CRN
- Cardiac CRN
- GI CRN
The primary objective of this Community of Practice (COP) is to assist CRN development as a robust source of evidence for device evaluation and serve as a foundational component of NEST. Secondary objectives include:
- Development of a repository of materials, tools, and best practices to support the maturity of the CRNs. Those resources are in the following areas: Device Identification, Quality Improvement/Beneficial Change, Total Product Life Cycle, Efficiency, Data Quality, and Governance.
- Development of a CRN assessment tool to evaluate CRN maturity and determine the specific needs of each CRN and guide the curation of resources to best meet each CRN’s needs. A maturity model would be useful to understand the level of development of each CRN to help plan further development.
- Development of individual CRN led interdisciplinary tactical teams that directly support CRNs in creating developmental plans and help CRNs track their progress.
- Development of recommendations to the NEST coordinating center (NESTcc) on the needs for future infrastructure and methodological development for CRNs.