MDEpiNet Registry Assessment of Peripheral Interventional Devices (RAPID)

Description
RAPID emerged from the Predictable And SuStainable Implementation Of National (PASSION) Registries for Cardiovascular Devices program of Medical Device Epidemiology Network (MDEpiNet), a public-private partnership supported by U.S. FDA funding to advance the nation’s approaches to the evaluation of medical devices.  It is one project in a series initiated to advance and support an interoperable flow of data & information across electronic health information systems with the intent to create a total product lifecycle (TPLC) approach to evaluate the medical device ecosystem.  

RAPID is focused on devices for peripheral vascular intervention as an archetype of the envisioned TPLC ecosystem.  A core minimum set of data elements related to the care & treatment of patients with peripheral arterial disease are being developed for use with data elements from the Global Unique Device Identification Database (GUDID) database to create a structured dataset that supports pre- & post-market assessment, quality improvement, & safety surveillance of peripheral interventional devices (Phase I). Subsequent phases will validate the data elements’ potential for implementation in various healthcare information systems such that structured, interoperable data is collected at the point of care & is available for use by patient registries, clinical research & medical device evaluation initiatives. Additionally, the RAPID data elements will inform the development of a global case report form & data collection instruments needed in the interim. This work facilitates peripheral arterial device development, addresses regulatory needs, & creates efficiencies that will reduce overall time & costs & support quality improvement efforts across the medical device lifecycle.

Participants include representatives of specialty societies, device manufacturers, electronic health information systems vendors, US FDA & other federal partners as well as international device registries & regulators. 
Start Date
09/01/2015
Projected End Date

    
Project Tags
  • Clinical Research
  • Common data elements
  • EHR
  • GUDID
  • interoperability
  • Medical Device Surveillance
  • PAD
  • Patient Registry
  • Unique Device Identifiers
Project Point of Contact: rebecca.wilgusremove@removeduke.edu
Project Results
None