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Difference between revisions of "March 15, 2016 UDI Project Meeting"

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=Attendees:=
 
=Attendees:=
*  
+
* Hans Buitendijk
*  
+
* Jose Costa Teixeira
*  
+
* Myron Finseth
*  
+
* Benhaz Minaei
*  
+
* Steve Rosenberg
 
+
* Terrie Reed
 +
* Marti Velezis
  
 
=Meeting Minutes:=
 
=Meeting Minutes:=
 
* March 8, 2016
 
* March 8, 2016
**  
+
** Table till next week
  
  
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*Review Use Cases Recommended for R1 ballot
 
*Review Use Cases Recommended for R1 ballot
 
** [http://wiki.hl7.org/index.php?title=File:UDITransactions_Use_Cases-Recommended.xlsx UDI Recommended Use Cases]
 
** [http://wiki.hl7.org/index.php?title=File:UDITransactions_Use_Cases-Recommended.xlsx 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:=
 
=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:=
 
=Next Meeting:=
*Tuesday, March 15, 2016, Noon - 1:00PM EDT
+
*Tuesday, March 23, 2016, Noon - 1:00PM EDT
 
*Phone: +1 770-657-9270, Passcode: 398652  
 
*Phone: +1 770-657-9270, Passcode: 398652  
 
*WebEx: https://fda.webex.com/fda/j.php?MTID=m40a6a072d9e4b354bb99222e7b0a04af
 
*WebEx: https://fda.webex.com/fda/j.php?MTID=m40a6a072d9e4b354bb99222e7b0a04af
 
**Meeting number: 741 298 577  
 
**Meeting number: 741 298 577  
 
**Meeting password: 123456
 
**Meeting password: 123456

Latest revision as of 16:15, 22 March 2016

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:

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: