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February 23, 2016 UDI Project Meeting
Minutes - Unique Device Identifier Implementation Guidance Project Meeting, February 23, 2016
Contents
Contents
- Attendees: Martha Velezis, Dan Morford, Ioana Singureanu, Karin Sailor, Russell Ott, Steve Rosenberger., Hans Buitendijk, Myron Finseth, Terrie Reed
- Meeting Minutes - Approve February 4, 2016, February 11, February 19
- Meeting Discussion:
- Review Updated Use Case Matrix
- SNOMED CT value set for implantable devices
- Action Items:
- PSS Status
- NIB
- 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