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Difference between revisions of "March 15, 2016 UDI Project Meeting"
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#Meeting Minutes - Approve March 8, 2016 | #Meeting Minutes - Approve March 8, 2016 | ||
#Meeting Discussion | #Meeting Discussion | ||
− | ##Review Recommended Use Cases | + | ##Review Updated Use Case Matrix - 3 use cases recommended for ballot R1 |
+ | ##[http://wiki.hl7.org/index.php?title=File:UDITransactions_Use_Cases-Recommended.xlsx UDI Recommended Use Cases] | ||
#Action Items | #Action Items | ||
− | + | ##None at this time | |
=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 |
=Meeting Discussion:= | =Meeting Discussion:= | ||
− | *Review | + | *Review Use Cases Recommended for R1 ballot |
− | ** [http://wiki.hl7.org/index.php?title=File:UDITransactions_Use_Cases.xlsx | + | ** [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 | + | *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
Contents
- Attendees
- 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
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
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