Next Steps: 2013 Action Plan
In 2013, the FDA will take these steps towards creating a national medical device postmarket surveillance system:
Summary of 2013 Planned FDA Actions
Proposed Deliverable Date
Actual Deliverable Date and Related Links
Medical Device Postmarket Surveillance System Governance
Establish a multi-stakeholder medical device postmarket surveillance system planning board to identify the governance structure, practices, policies, procedures, methods and business model(s) necessary to facilitate the creation of a sustainable, integrated medical device postmarket surveillance system that leverages and complements existing and on-going efforts.
Establish a unique device identification (UDI) system and promote its incorporation into electronic health information
Finalize the Unique Device Identification (UDI) rule.
Develop and implement a fully functional and publically accessible global UDI database (GUDID) to provide detailed, non-confidential device information to stakeholders and the general public.
Provide UDI technical requirements and UDI electronic health record (EHR) use cases to Office of the National Coordinator for Health Information Technology (ONC) standards workgroups to facilitate UDI adoption as part of EHR certification.
Complete technical and final reports on a pilot, demonstrating issues and challenges involved in incorporating UDI into a multi-hospital information system.
Complete an initial think tank report to inform the development of a roadmap for successful UDI implementation addressing critical issues including: 1) opportunities and challenges associated with capturing UDIs in claims; 2) steps necessary for implementation and integration of UDI within electronic data infrastructure of care delivery sites; and 3) patient and provider access to and linking of device information across data sources.
Promote the development of national and international device registries for selected products
Establish a Medical Device Registry Task Force consisting of key stakeholders under CDRH’s Medical Device Epidemiology Network (MDEpiNet) Program to: 1) identify ex-isting registries that may contribute to the system; 2) leverage on-going registry efforts focused on quality improvement, reimbursement, patient-centered outcomes and other activities to best meet the needs of multiple stakeholders; 3) identify priority medical device types for which the establishment of a longitudinal registry is of significant public health importance; 4) define registry governance and data quality practices that promote rigorous design, conduct, analysis, and transparency to meet stakeholder needs; and 5) develop strategies for the use of registries to support premarket approval and clearance.
Modernize adverse event reporting and analysis
Issue final reports on two pilots demonstrating use of ASTER-D for the detection and automated reporting of select device-related adverse events though hospital electronic health records.
Implement a mobile application for voluntary adverse event reporting.
Pilot an initial functional release of the FDA Adverse Event Reporting System (FAERS), a modernized database for adverse event reports.
Implement prospective “data mining” tools in at least three major device areas to enhance the identification of high quality adverse event reports and report trends and clusters.
Develop and use new methods for evidence generation, synthesis and appraisal
Identify gaps in current methodological efforts to promote data standardization, interoperability, and linkage between registries and disparate data sources.
Advance the development of interoperability between registries and electronic health records by: 1) beginning collaboration with stakeholders on the use of structured data capture capabilities within electronic health information sources; 2) facilitating a demonstration pilot focusing on registry-EHR integration; and 3) assessing methodologies to optimize linkage of registries with other longitudinal data sources such as administrative and claims data.
Collaborate with stakeholders and leverage on-going efforts to develop methodologies for evidence synthesis for two classes of implantable devices to combine diverse data sources and/or combine data from multiple registries to provide more timely and comprehensive assessments of device benefit-risk profiles.