OO CR061-709 Serial Number

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Submitted by: Jose Costa Teixeira	Revision date: <<Revision Date>>
Submitted date: May 19, 2011	Change request ID: OO CR061
Standard/IG: 2.8 Standard	Artifact ID, Name: <<Artifact ID, Name>>

Issue

See 2.8 change request File:OO CR061.doc for problem definition and proposal.

Resolution

20-May-2011

• The use case is not fully clear to us as it includes some references to pace makers in the context of pharmacy. Are you trying to communicate which device is used to dispense, provide give instructions, or administer? Or, are you trying to communicate what device(s) the patient already has implanted or attached? Or are you trying to communicate what device to implant? Or something different altogether?
  • The device that has been dispensed, administered, etc. e.g., insulin pump.
  • Distinguish between lot/batch and an individual
  • Use PRT for the insulin pump type situation
• For this discussion, the difference between lot and batch does not matter as much we think, but it may depending on how you define serial number and device above.
• We think we have an approach that would work, not necessarily as you proposed it, but need further use case information to determine how to best support this.
• Also, we would suggest that if we are talking about the same serial number concept, that UDI should be a recommended implementation approach where possible/appropriate
• We agreed that this proposal is not required in light of the resolution to proposal OO CR062-711 and the discussion.

The proposal was withdrawn.