February 23, 2016 UDI Project Meeting

Minutes - Unique Device Identifier Implementation Guidance Project Meeting, February 23, 2016

Contents

1. Attendees: Martha Velezis, Dan Morford, Ioana Singureanu, Karin Sailor, Russell Ott, Steve Rosenberger., Hans Buitendijk, Myron Finseth, Terrie Reed
2. Meeting Minutes - Approve February 4, 2016, February 11, February 19
3. Meeting Discussion:
   1. Review Updated Use Case Matrix
   2. SNOMED CT value set for implantable devices
4. Action Items:
   1. PSS Status
   2. NIB
5. Next Meeting:

Attendees:

• Martha Velezis,
• Dan Morford,
• Ioana Singureanu,
• Karin Sailor,
• Russell Ott,
• Steve Rosenberger,
• Hans Buitendijk,
• Myron Finseth,
• Terrie Reed

Meeting Minutes:

• Motion to accept Feb 4, 2016 as distributed. Steve Rosenberg, Myron Finseth.
  • Against: 0; Abstain: 4; In Favor: 4

Meeting Discussion:

• Review Updated Use Case Matrix
  • Spreadsheet was distributed and various discussions on the list serve.
  • Established 4 more columns to clarify Location/Venue, Personnel, System, and Notes.
  • Spreadsheet will be used as input into the DAM to fill out all the relevant sections.
  • Any suggestions for fixes should be put on the list serve or brought up in the meeting, or mark-up spreadsheet.
  • Catherization use case has been added.
  • Reviewed UC#7.3 focusing on replacement of leads.
    • Need to consider that leads are typically packaged separately and replacements very likely do not share the same PI and may not share the same DI as the original leads.
    • Need to clarify that the implantable device list is available, thus will require a spin-off use case on how to get that information if not already in the local system.
    • Need to clarify who the care provider(s) that need to receive the implantable device list.
    • Need to record procedure and share through Transition of Care. Also may need to clarify whether it needs to go to a registry.

Action Items:

• PSS passed SSD-SD
• NIB was submitted for May ballot

Next Meeting:

• Tuesday, March 8, 2016, Noon - 1:00PM EDT
• Phone: +1 770-657-9270, Passcode: 398652
• WebEx: https://fda.webex.com/fda/j.php?MTID=m40a6a072d9e4b354bb99222e7b0a04af
  • Meeting number: 741 298 577
  • Meeting password: 123456