PSS-1688 - Getting issue details... STATUS

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FHIR IG Registry Framework Questions Keith W. Boone

CIC - VANGUARD, Marti Velezis, FDA

Introduction of the VANGUARD Project - (Venous Access 

National Guideline and Registry Development)

CRN Stakeholders - reviewed. All CRNs are connected to professional societies. An EPI-NET - 12 CRNs that are associated with it. 

Kevin Baskin is the primary investigator/lead. Review of the tracks of VANGUARD (working on it 5-10 years.) Some are in flight, some conceptual. Work on access to data is in process for agreements for the different tracks. Tracks are all paper processes, not digital. 

Main focus for discussion:

• UDI and devices: AUDI with SIR data (UDI Track)
• Infrastructure - Vascular anatomy - outcome data is difficult on placement of catheters due to limited data on placement.  Describing the anatomy - difficult to document.

Goal is to work on individual tracks to build out infrastructure. A lot of the data is not collected. No financial incentives for physicians to report the data.  Clinical Checklist for physicians to follow and report. 

VANGUARD brings in very specific device characteristics that is not included in other CRNs. A Delphi process is used to propose data elements that are thought to be clinically relevant.  

Data spreadsheets available: Venous Access

Next work will be mappings for FHIR. Everything in Common Clinical Device characteristics-should be applicable to all CRNS;  will be supported across all CRNs. UDI Implementation Guide will be the Core characteristic profile. Should also align with US Core - if possible. Will create a FHIR IG based on US Core. Implantable device profile from US Core, then non-implantable, then device profile from Women's Technology. OO WG - work coming from them - will be cross-paradigm IG. Will provide guidance on how to address devices in IG.