The National Medical Device Registry Task Force consists of key registry stakeholders under the FDA’s Center for Devices and Radiological Health’s (CDRH) Medical Device Epidemiology Network (MDEpiNet) Program. CDRH will leverage the existing MDEPiNet Public Private Partnership via the Partnership Coordinating Center at Duke Clinical Research Institute at Duke University.
1. Identify existing registries that may contribute to a National Medical Device Post-market Surveillance System
- Develop robust criteria to identify existing operational registries that can contribute to the National Medical Device Post-market Surveillance System Register of Registries
- Define potential synergies with international registries in the development of the national system and evaluate the extent to which their best practices could be leveraged
2. Leverage on-going registry efforts focused on quality improvement, reimbursement, patient-centered outcomes, and other related activities to best meet the needs of multiple stakeholders
- Describe possible approaches to integration and re-purposing of on-going registries into the national system including linking to other data sources
- Propose mechanisms to drive substantive and productive collaboration between registries while encouraging each registry to strengthen its unique capabilities
- Propose approaches and incentives to interdisciplinary utilization of registries and sharing resources, tools and results
3. Identify priority medical device types for which the establishment of a longitudinal registry is of significant public health importance, such as a subset of Class III or permanently implantable Class II medical devices
- Propose mechanisms to involve all stakeholders in all phases of prioritization
- Examine existing efforts (e.g., Pew effort ) and identify gaps in prioritization
- Develop prioritization criteria for the establishment of new registries
4. Identify and prioritize successful registry governance and data quality best practices that promote rigorous design, conduct, analysis, and transparency to meet needs of stakeholders, including FDA.
- Define registry (consortia of registries) governance in the context of the national system
- Evaluate existing governance models and identify opportunities for creating a sustainable model for active engagement of industry, government agencies, academia, private foundations, community advocates and organizations, patients, family members and other stakeholders.
- Identify strategies, practices and procedures that can assure the seamless entry of data into registries as part of the normal workflow of clinical practice
- Identify what data should be commonly collected across all medical device registries
- Identify and prioritize viable business models for establishing and maintaining registries
5. Develop strategies for the use of registries to support premarket approval and clearance as well as post-market indication extensions in labeling.
- Market IDE applications
- Identify specific strategies to streamline and promote adoption of registries as platforms for IDE studies
- Assess potential of registries to drive innovation and define the roles of stakeholders
- Explore opportunities and incentives to engage the stakeholders in pilot efforts
The logistical operations of the Task Force will be coordinated through Duke University as a third-party convener. These will include:
- Convene face-to-face and virtual meetings of the Task Force over a period of 12 months.
- Handle meeting logistics and travel arrangements.
- Support development of a series of reports that address the individual tasks assigned to the Task Force.
- The reports are to document the assessment and evaluation of each task, note major considerations, and provide options to be considered for further national development.
- Set up public meetings to garner further input on the work products of the Task Force.
The Task Force will be comprised of experts from existing registries and/or registry consortia, regulatory and public health authorities, product manufacturers, health care service providers, integrated health care systems, payers, patient and advocacy group, academic institutions, professional societies and other stakeholders. Expert experience of interest will include:
- Experience in developing, and/or using data from patient registries for quality improvement, patient-centered outcomes research, regulatory/reimbursement mandates, regulatory applications and other purposes;
- Experience in the development national research and health care policy, public health policy, medical device industry research and development, regulatory science, safety surveillance, national reimbursement decisions, ethics, data ownership and privacy, interface between registries with electronic health records and other data sources.
Five sub-committees will be formed to more efficiently address the five distinct charges to the Task Force.
The Sub-committees will be charged with developing:
- Scope of the work to be done,
- Approaches to how work might be done,
- Phases of work to be done,
- Timeframe for doing work.
This initial “roadmap” would inform the large group discussion and deliverables.
The Task Force will produce a final report providing
- Detailed assessment and evaluation of the five areas of focus and
- Provide specific options to be considered for further national development.
The public will have an opportunity to comment on options from the Task Force before a decision is made to implement them.
Read the Task Force Report August 24, 2015