A new paper from the planning board for a national medical device evaluation system describes how the nation can implement a coordinated network to gather evidence on the safety and effectiveness of medical devices.
The planning board is a multi-stakeholder group representing researchers, government officials, experts in health information systems and more. This first paper is one in a series of reports on medical device safety. It gives recommendations for a coordinator center that will be responsible for creating a national medical device evaluation system (NMDES).
Device tracking today consists of a range of narrowly targeted databases, projects and registries that generally focus on a small number of high-risk devices and shorter-term outcomes, according to the report. Current limitations include the lack of unique device identifiers (UDIs) to track medical devices, manual data entry, the difficulty in using EHRs for device tracking and limited participation by health providers. A group of provider organizations have backed UDI mandates and a requirement in Meaningful Use Stage 3 for a field for UDI data in EHRs.
The planning board envisions that the NMDES will include:
- Standardized data from multiple sources, including EHRs, claims, registries, patient reported outcomes and clinical trials
- A clearinghouse of expertise, tools and best practices to detect safety events and to study clinical effectiveness of new technologies
- Up-to-date, reliable information on benefits and risks of medical devices to help doctors and patients in their decision-making
The NMDES should give device manufacturers a faster, more predictable path to approval and it should give clinicians and insurers greater confidence in products on the market, the report states.
The board recommends establishing a coordinating center to provide governance, coordination and standardization to drive down the time and cost of generating evidence.
To learn more:
- read the report (.pdf)