RAPID Working Group Meeting

Meeting Objectives

• Share RAPID overview with new stakeholders
• Finalize RAPID Phase I 
  • Face-to-face meetings of clinical, informatics and GUDID work groups to finalize Phase I work of prior conference calls
  • Work group reports and group discussion of any lingering issues
  • Identify strategy for reporting deliverables and finishing Phase I

   

• Develop pathway to execute RAPID Phase II 
  • Learning from others
  • Potential benefit for payers
  • Workable deadline and milestones

   

• Discuss potential mechanisms and/or clinical studies where RAPID Phase III may be implemented     
  • Manufacturers interests
  • International collaborations
  • US regulations and potential execution

   

AGENDA

07:30-8:00 AM           Registration and Refreshments

08:00-8:50 AM           Welcome

RAPID:  Within the context of a National Medical Device Surveillance System

Mitch Krucoff, Duke University

RAPID: Current state, and Plan for the day

Pablo Morales, FDA

Jack Cronenwett, Dartmouth-Hitchcock

Robert Thatcher, Cardiovascular Systems

09:00 -11:00 AM        Working Group break-outs: Finalize RAPID Phase I deliverables

 Clinical Work Group                                                                                                                      

Schuyler Jones, Duke University

• Review work group, timeline, work performed, and key contributions
• Finalize Phase I list of 100 data elements     
  • Complete remaining data element and permissible value definitions
  • Complete remaining mapping of RAPID data elements to registries/trials’ CRFs

   

• Plan & establish timeline for reporting deliverables
• Summarize lessons learned and key points for report out to large group
• Roadmap / assignments of work required to reach goals of Phase II and III

Informatics Work Group

James Tcheng, Duke University

• Review working group goals, timeline, and key contributions
• Finalize the minimum meta-data for the RAPID common clinical terminology set
• High level review the work product of the clinical WG (informatics conformance perspective)
• Plan the formulation / composition of the work product that will be most useful to (non-informatics) stakeholders
• Plan the work (including resourcing) to accomplish an informatics instantiation of the RAPID common clinical term set
• Discuss the “supplemental” UDI content gap from a principles / framework perspective (with the GUDID WG)
• Plan & establish timeline for reporting deliverables

GUDID Work Group

Terrie Reed, FDA

• Review working group goals, timeline, and key contributions
• Review GUDID Summary and work on generalizing learnings from peripheral vascular registry experience to other device registries
• Plan & establish timeline for reporting deliverables
• Roadmap / assignments of work required to reach goals of Phase II and III

11:00 -11:15 AM        Break & Box lunch set-up

11:15-12:45 PM          Integration of Work Groups

Moderator: Jack Cronenwett, Dartmouth-Hitchcock

Working lunch, reports from each work group & discussion of topics that need joint review as we move into Phase II planning

Break-out Session Reports

• Clinical WG             Schuyler Jones, Duke University
• Informatics WG     James Tcheng, Duke University
• GUDID Work Group Terrie Reed, FDA

Commentators:

Barry Daniels,GMDN – Use of GMDN or other device categories

Julia Skapik, ONC – Integration with national data standards

12:45-1:00 PM            Break

1:00-2:30PM               RAPID Phase II, Core Data Set Extraction Moderator: Pablo Morales, FDA

Operationalizing data extraction from multiple sources using the core PVI dataset

• Realities of UDI extraction: BUILD/Mercy’s experience

Joe Drozda, Mercy Health System

• Partnering with payers for data extraction /BMC2 experience

Hitinder Gurm, University of Michigan

• CMS use of registry data for quality reporting

Sophia Autrey, Center for Medicare and Medicaid Services

• Extracting RAPID data elements from EHR systems

Bret Shillingstad, Epic

• Open discussion

2:30 – 2:45 PM           Break

2:45-3:45 PM              RAPID Phase III

Moderators: Robert Thatcher, Cardiovascular Systems, Jack Cronenwett, Dartmouth-Hitchcock

Utilizing the RAPID core data set for research, quality improvement and safety surveillance

Perspectives from the medical device industry

• Margo Zaugg, Abbott Vascular
• Megan Brandt, Cardiovascular Systems, Inc
• John van Vleet, C.R.Bard
• Aaron Lottes, Cook Medical

Perspectives from international partners

Sara Takahashi, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

3:45-4:00 PM              MDEpiNet Perspective, Next Steps

Danica Marinac-Dabic, FDA

Pablo Morales, FDA

Jack Cronenwett, Dartmouth-Hitchcock

Robert Thatcher, Cardiovascular Systems