RAPID - Phase I GUDID

Members of the RAPID GUDID Integration Working Group explored operational opportunities to adopt and demonstrate the usefulness the GUDID as a means for standardizing device data and improving the ability to link across peripheral device registries. The primary responsibilities of this Work Group were to:

1.  Define a best practice for accessing and downloading data attributes from the GUDID into existing registry data sources.

2.  Review and provide feedback on the clinical relevance of the Global Medical Device Nomenclature/SNOMED CT for PVI devices (e.g., plain balloon, specialized balloon, self- expanding bare metal stent, balloon expandable bare metal stent, drug coated stent, covered stent, atherectomy device, total occlusion device, embolic protection device).

3.  Agree on a key set of core data attributes available in GUDID that each registry could download and then extract the information needed for their registry.

4.  Provide feedback on the ability to link/expand existing registries to accommodate the use of the device identifier, the key in the GUDID, to ensure the ability to download from clinical data sources that are expected to capture UDI information when such systems become more widely available.

Additionally, members collaborated with the RAPID Informatics Working Group and the RAPID Clinical Expert Working Group to determine device identification data elements that should be included in the RAPID core data element set.

39 People from 23 Organizations

  • 4C Medical Technologies

  • American College of Cardiology

  • BARD

  • Boston Scientific

  • Cardiovascular Systems, Inc (CSI)

  • Centers for Medicare and Medicaid Services (CMS)

  • Cook Medical

  • Department of Defense (DoD)/ AHRMM

  • Duke University/Duke Clinical Research Institute (DCRI)

  • Epic

  • GMDN Agency

  • M2S

  • Medtronic

  • Mercy Health System

  • National Library of Medicine (NLM)

  • Society for Interventional Radiology

  • Society for Vascular Surgery

  • Society of Interventional Radiology

  • University of Washington Health Sciences Center

  • University of Michigan

  • US Food and Drug Administration (US FDA)

  • Volcano Corp/Philips Health Technology

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