In 2012, the Food and Drug Administration’s Center for Devices and Radiologic Health created an action plan for a national postmarket surveillance system for medical devices. In 2014, The Brookings Institutions — a nonprofit research and policy solutions organization — convened a planning board to oversee the development of such a system through its Engelberg Center for Health Care Reform.
To realize its long-term vision for the National Medical Device Postmarket Surveillance System, also known as MDS, the planning board recommends:
- Initiating a two-year incubator project tasked with creating a detailed development plan for the first five years of the MDS public-private partnership.
- Developing the core system capabilities, framework, organizational structure, mechanisms to ensure data privacy, and more.
- Undertaking a series of fact-finding activities to inform the development of the implementation plan.
- Identifying and leveraging recent or ongoing projects that test core capabilities and data infrastructures that could ultimately support MDS.
- Coordinating feasible pilot projects that could be used to inform more specific plans on how MDS can best be implemented.
- Developing and executing the criteria and process for selecting MDS leadership and host organization.
- Collaborating with other public and private stakeholders to provide approximately $5 million to $6 million in funding for the two-year incubator project.
- Ensuring that MDS is integrated into the larger national infrastructure for evidence development.
- Forming key strategic partnerships with other medical product evidence development activities.
- Developing the data infrastructure policies to ensure that patients’ privacy is protected.
To find out more about the National Medical Device Postmarket Surveillance System or the planning board’s recommendations, read the full Brookings Institute report here.
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