Use Case 32: Medical device data capture and exchange

From Demand-Driven Open Data
(Redirected from Use Case 32)
Jump to: navigation, search

Want to be notified when this use case or any of its datasets change?
You’re signing up to be notified on changes to this use case and associated data sources
* indicates required

Use Case

Use case summary

Description

  • This project proposes to assess leading practices and future directions in the capture and exchange of device data at health care delivery sites. Particular focus will be on higher risk devices, Class III and Class II implantable devices. This is a foundational step for the availability of robust device data for use in comparative effectiveness research and postmarket surveillance to inform device safety and protect public health. To date, leading practices have not been assessed and aggregated beyond a few single health care organizations engaged in electronic capture and exchange of data and use of unique device identification (UDI). Compiling and disseminating information on leading practices and directions would expand adoption and implementation of data capture and exchange across the broader healthcare spectrum
    • Support development of datasets through delineation of leading practice capture and exchange of device data from health care delivery sites
    • Support improved use of medical device data throughout the product life cycle
    • Support assessment of device risk/benefit
    • Support harmonization of UDI information
    • Conceptualize new technologies to optimize device data capture and exchange
  • Effective capture and exchange of device data at health care delivery sites is a foundational step for the availability of robust device data for use in comparative effectiveness research and postmarket surveillance to inform device safety and protect public health


Value

  • Value to customer: Enable device data capture, exchange and use to inform device safety and protect public health.
  • Value to industry/public: Although UDI (unique device identification) implementation has been long in the making, very few organizations have attempted to leverage UDI availability. Effective capture and exchange of device data at health care delivery sites is a foundational step for the availability of robust device data for use in comparative effectiveness research and postmarket surveillance to inform device safety and protect public health. There is significant potential to extend broad adoption of methods to capture and exchange device data.


Customer


Current data

Through its premarket review process, the FDA makes every effort to assure that risks associated with medical devices have been minimized when those devices first enter the market. However, once medical devices are widely used by health care providers and patients, new issues occasionally arise.

Postmarket surveillance is a collection of processes and activities the FDA uses to monitor the safety and effectiveness of medical devices once they are on the market. These activities are designed to generate information to quickly identify poorly performing devices and other safety problems, accurately characterize real-world device performance and clinical outcomes, and facilitate the development of new devices, or new uses for existing devices.


Standards Adoption


Status

  • Paper in American Heart Journal: Unique device identifiers for coronary stent postmarket surveillance
    • Convened expert panel:.
      1. FDA representatives
      2. Industry manufacturers
      3. Interventional cardiologists
      4. Health system members of the Healthcare Transformation Group
      5. NCDR (National Cardiovascular Data Registry)
    • Identified 3 deliverables:
      1. Use cases for UDI-associated data (eg, research)
        • 18 use cases, encompassing clinical care, supply chain management, consumer information, research, regulatory, and surveillance domains
      2. Supplemental data set of clinically relevant attributes (eg, stent dimensions)
        • Besides the attributes of FDA's GUDID (Global Unique Device Identification Database), 9 additional coronary stent-specific attributes were required to address use case requirements
      3. Governance and administrative principles for the authoritative management of UDI data



Next steps

As of 7/6/2015... AHRMM/AHA will identify need for DDOD to be involved, based on status of funding for HTG-led project. (There's a 3-year project scope, that includes development, data collection and analysis.

Want to be notified when this use case or any of its datasets change?