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(Created page with "Orders and Observations Work Group return to previous menu Universal Device Identifier - Requirements Project The UDI Requirements Project is separate and distinct from the ...")
 
 
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Orders and Observations Work Group
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Back to [[Orders & Observations WG]] main page
return to previous menu
 
  
Universal Device Identifier - Requirements Project
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Universal Device Identifier - Use Cases Project
  
 
The UDI Requirements Project is separate and distinct from the UDI Task Force current under the TSC.  This
 
The UDI Requirements Project is separate and distinct from the UDI Task Force current under the TSC.  This
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sponsored by the Orders & Observations work group.
 
sponsored by the Orders & Observations work group.
  
[[UDI Agendas and Summaries (aka Notes, aka Minutes)]]
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= Project Resources =
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==[[UDI Agendas and Summaries (aka Notes, aka Minutes)]]==
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==Regular Teleconference Coordinates==
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Note dates/times sometimes change based on availability.  See hl7.org and/or join the listserv for udpates
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Dates: On Selected Tuesdays, Next Meeting is: Tuesday, July 26, 2016
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Time: 12:00pm - 1:00pm EST
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Number: +1 (770) 657 9270
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Participant Passcode: 398652
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*WebEx: https://fda.webex.com/fda/j.php?MTID=m40a6a072d9e4b354bb99222e7b0a04af
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**Meeting number: 741 298 577
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**Meeting password: 123456
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==Activities Schedule==
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*6/30/2016      Add new primary author for DAM
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*''7/26/2016      Next project meeting - Status DAM''
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*8/14/2016 Announcement of peer review which starts 8/28/2016
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*''8/23/2016      Next project meeting - Ensure everyone and doc ready for peer review''
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*8/28/2016-9/10/2016 2 week peer review
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*9/10/2016 Final Day for submission of peer review comments
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*9/17-23/2016    Baltimore WGM and Plenary, Reconcile Peer Review comments
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*''10/04/2016      Project meeting, Peer Review comment reconciliation
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*''10/18/2016      Project meeting, Peer Review comment reconciliation
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*10/24/2016 Start of 2 weeks for changes to DAM doc to address reconciled issues from peer review
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*'''11/5/2016      Ballot submission - initial content'''
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*''11/29/2016      Project Meeting - Final document approval''
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*'''12/4/2016 Ballot submission – final content'''
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==Use Case Materials==
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* Spreadsheet
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** This [http://wiki.hl7.org/index.php?title=File:UDITransactions_Use_Cases.xlsx spreadsheet] is used to gather relevant use cases that will then be used to develop the DAM.
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** This [http://wiki.hl7.org/index.php?title=File:UDITransactions_Use_Cases-Recommended.xlsx spreadsheet] contain the recommended use cases to be included in R1.
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** This [http://wiki.hl7.org/index.php?title=File:Medical%2BDevice%2BIdentification%2BConceptual%2BSpecification%2BR1.doc document] contains the latest UDI DAM documentation in progress.
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* [http://wiki.hl7.org/index.php?title=File:Sample_Labels_with_barcodes_for_FDA.PDF Label Samples]
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==Backlog Items==
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* HIBCC informative HRF using parenthesis vs. harmonization document curly braces.
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* OIDs at agency level vs. FDA level.  Perhaps even format level.

Latest revision as of 15:36, 30 June 2016

Back to Orders & Observations WG main page

Universal Device Identifier - Use Cases Project

The UDI Requirements Project is separate and distinct from the UDI Task Force current under the TSC. This project is to develop and document the use cases and other conceptual items which constitute the need and specific characteristics and constraints on uniquely identifying medical devices. This project is sponsored by the Orders & Observations work group.

Project Resources

UDI Agendas and Summaries (aka Notes, aka Minutes)

Regular Teleconference Coordinates

Note dates/times sometimes change based on availability. See hl7.org and/or join the listserv for udpates

Dates: On Selected Tuesdays, Next Meeting is: Tuesday, July 26, 2016

Time: 12:00pm - 1:00pm EST

Number: +1 (770) 657 9270

Participant Passcode: 398652

Activities Schedule

  • 6/30/2016 Add new primary author for DAM
  • 7/26/2016 Next project meeting - Status DAM
  • 8/14/2016 Announcement of peer review which starts 8/28/2016
  • 8/23/2016 Next project meeting - Ensure everyone and doc ready for peer review
  • 8/28/2016-9/10/2016 2 week peer review
  • 9/10/2016 Final Day for submission of peer review comments
  • 9/17-23/2016 Baltimore WGM and Plenary, Reconcile Peer Review comments
  • 10/04/2016 Project meeting, Peer Review comment reconciliation
  • 10/18/2016 Project meeting, Peer Review comment reconciliation
  • 10/24/2016 Start of 2 weeks for changes to DAM doc to address reconciled issues from peer review
  • 11/5/2016 Ballot submission - initial content
  • 11/29/2016 Project Meeting - Final document approval
  • 12/4/2016 Ballot submission – final content

Use Case Materials

  • Spreadsheet
    • This spreadsheet is used to gather relevant use cases that will then be used to develop the DAM.
    • This spreadsheet contain the recommended use cases to be included in R1.
    • This document contains the latest UDI DAM documentation in progress.
  • Label Samples

Backlog Items

  • HIBCC informative HRF using parenthesis vs. harmonization document curly braces.
  • OIDs at agency level vs. FDA level. Perhaps even format level.