March 15, 2016 UDI Project Meeting
Minutes - Unique Device Identifier Implementation Guidance Project Meeting, March 15, 2016
- Meeting Minutes - Approve March 8, 2016
- Meeting Discussion
- Review Updated Use Case Matrix - 3 use cases recommended for ballot R1
- UDI Recommended Use Cases
- Action Items
- None at this time
- Hans Buitendijk
- Jose Costa Teixeira
- Myron Finseth
- Benhaz Minaei
- Steve Rosenberger
- Terrie Reed
- Marti Velezis
- March 8, 2016
- Table till next week
- Review Use Cases Recommended for R1 ballot
The group discussed the Use Cases Recommended for Round 1 (use cases that were distributed on list serve): · For the first round we are deferring any technology requirements
- Issue was raised around the barcode and multiple ways that the information may be entered in any one of the use cases (e.g., AIDC, HRF, etc.); and there are fault patterns that may exist (e.g., the barcode is not found, it is not computable), etc. We will need to address these in a future release.
- Also removed documentation pathways – it was marked yellow in the initial recommendation.
- Under the “ordering” use cases we removed the materials/catalog/inventory management piece as it is will be a lot of work in this first phase; also there is another activity on this topic (i.e., white paper) being developed that should help to articulate the complexities (although it is not specific to UDI).
- Vote was taken: Motion made by Terrie Reed/Jose Costa Teixeira to accept the three use cases (implant, explant and replace medical device). Note – this includes the yellow highlighted use cases attached.
- Vote: For: 6, Against: 0, Abstain: 0
- Patrick to start modeling/documenting the use cases in the DAM template (for discussion/review next time)
- Solicit additional information via list serve if necessary
- Tuesday, March 23, 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