March 15, 2016 UDI Project Meeting

Minutes - Unique Device Identifier Implementation Guidance Project Meeting, March 15, 2016

Contents

1. Attendees
2. Meeting Minutes - Approve March 8, 2016
3. Meeting Discussion
   1. Review Updated Use Case Matrix - 3 use cases recommended for ballot R1
   2. UDI Recommended Use Cases
4. Action Items
   1. None at this time

Attendees:

• Hans Buitendijk
• Jose Costa Teixeira
• Myron Finseth
• Benhaz Minaei
• Steve Rosenberg
• Terrie Reed
• Marti Velezis

Meeting Minutes:

• March 8, 2016
  • Table till next week

Meeting Discussion:

• Review Use Cases Recommended for R1 ballot
  • UDI Recommended Use Cases

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

Action Items:

• 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

Next Meeting:

• 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