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Difference between revisions of "February 23, 2016 UDI Project Meeting"

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=Contents=
 
=Contents=
#Attendees:
+
#Attendees: Martha Velezis, Dan Morford, Ioana Singureanu, Karin Sailor, Russell Ott, Steve Rosenberger., Hans Buitendijk, Myron Finseth, Terrie Reed
 
#Meeting Minutes - Approve February 4, 2016, February 11, February 19
 
#Meeting Minutes - Approve February 4, 2016, February 11, February 19
 
#Meeting Discussion:
 
#Meeting Discussion:
 
##Review Updated Use Case Matrix
 
##Review Updated Use Case Matrix
 +
##SNOMED CT value set for implantable devices
 
#Action Items:
 
#Action Items:
 
##PSS Status
 
##PSS Status
 +
##NIB
 
#Next Meeting:
 
#Next Meeting:
  
 
=Attendees:=
 
=Attendees:=
*  
+
* Martha Velezis,
*
+
* Dan Morford,
*
+
* Ioana Singureanu,
 +
* Karin Sailor,
 +
* Russell Ott,
 +
* Steve Rosenberger,
 +
* Hans Buitendijk,
 +
* Myron Finseth,
 +
* Terrie Reed
 +
 
 +
=Meeting Minutes:=
 +
* Motion to accept Feb 4, 2016 as distributed.  Steve Rosenberg, Myron Finseth.
 +
** Against: 0; Abstain: 4; In Favor: 4
  
 
=Meeting Discussion:=
 
=Meeting Discussion:=
*  
+
*Review Updated Use Case Matrix
*
+
** Spreadsheet was distributed and various discussions on the list serve.
*
+
** Established 4 more columns to clarify Location/Venue, Personnel, System, and Notes.
 +
** Spreadsheet will be used as input into the DAM to fill out all the relevant sections.
 +
** Any suggestions for fixes should be put on the list serve or brought up in the meeting, or mark-up spreadsheet.
 +
** Catherization use case has been added.
 +
** Reviewed UC#7.3 focusing on replacement of leads.
 +
*** Need to consider that leads are typically packaged separately and replacements very likely do not share the same PI and may not share the same DI as the original leads.
 +
*** Need to clarify that the implantable device list is available, thus will require a spin-off use case on how to get that information if not already in the local system.
 +
*** Need to clarify who the care provider(s) that need to receive the implantable device list.
 +
*** Need to record procedure and share through Transition of Care.  Also may need to clarify whether it needs to go to a registry.
  
 
=Action Items:=
 
=Action Items:=
*
+
* PSS passed SSD-SD
*
+
* NIB was submitted for May ballot
*
 
  
 
=Next Meeting:=
 
=Next Meeting:=
*Friday, March 2, 2016, Noon - 1:00PM EDT
+
*Tuesday, March 8, 2016, Noon - 1:00PM EDT
 
*Phone: +1 770-657-9270, Passcode: 398652  
 
*Phone: +1 770-657-9270, Passcode: 398652  
*WebEx: TBD
+
*WebEx: https://fda.webex.com/fda/j.php?MTID=m40a6a072d9e4b354bb99222e7b0a04af
 +
**Meeting number: 741 298 577
 +
**Meeting password: 123456

Latest revision as of 15:11, 8 March 2016

Minutes - Unique Device Identifier Implementation Guidance Project Meeting, February 23, 2016

Contents

  1. Attendees: Martha Velezis, Dan Morford, Ioana Singureanu, Karin Sailor, Russell Ott, Steve Rosenberger., Hans Buitendijk, Myron Finseth, Terrie Reed
  2. Meeting Minutes - Approve February 4, 2016, February 11, February 19
  3. Meeting Discussion:
    1. Review Updated Use Case Matrix
    2. SNOMED CT value set for implantable devices
  4. Action Items:
    1. PSS Status
    2. NIB
  5. Next Meeting:

Attendees:

  • Martha Velezis,
  • Dan Morford,
  • Ioana Singureanu,
  • Karin Sailor,
  • Russell Ott,
  • Steve Rosenberger,
  • Hans Buitendijk,
  • Myron Finseth,
  • Terrie Reed

Meeting Minutes:

  • Motion to accept Feb 4, 2016 as distributed. Steve Rosenberg, Myron Finseth.
    • Against: 0; Abstain: 4; In Favor: 4

Meeting Discussion:

  • Review Updated Use Case Matrix
    • Spreadsheet was distributed and various discussions on the list serve.
    • Established 4 more columns to clarify Location/Venue, Personnel, System, and Notes.
    • Spreadsheet will be used as input into the DAM to fill out all the relevant sections.
    • Any suggestions for fixes should be put on the list serve or brought up in the meeting, or mark-up spreadsheet.
    • Catherization use case has been added.
    • Reviewed UC#7.3 focusing on replacement of leads.
      • Need to consider that leads are typically packaged separately and replacements very likely do not share the same PI and may not share the same DI as the original leads.
      • Need to clarify that the implantable device list is available, thus will require a spin-off use case on how to get that information if not already in the local system.
      • Need to clarify who the care provider(s) that need to receive the implantable device list.
      • Need to record procedure and share through Transition of Care. Also may need to clarify whether it needs to go to a registry.

Action Items:

  • PSS passed SSD-SD
  • NIB was submitted for May ballot

Next Meeting: