2013-12-19 TSC UDI Task Force

TSC UDI TF

Meeting Info/Attendees

HL7 TSC Meeting Minutes Location: https://global.gotomeeting.com/join/134453157		Date: 2013-12-19 Time: 4:00 PM U.S. Eastern
Facilitator: Paul Knapp		Note taker(s): Lynn Laakso

Quorum not defined
Attendee		role
x	Erin Fields	FDA
x	Christian Hay	GS1
x	Paul Knapp	FTSD co-chair, UDI Task Force Chair, ITS and FM cochairs, FMG
x	Lynn Laakso	HL7

Agenda

1. Roll Call
2. Review draft agenda
3. Review last discussion at 2013-11-21 TSC UDI Task Force
   • Review the updated spreadsheet, pattern document, and addenda to specify representation in V2, V3, etc.
   • Once the document is signed off it can go to an out of cycle harmonization.
4. Adjourn

Minutes

Minutes/Conclusions Reached:
Call to order 4:09 PM

1. Review draft agenda
2. Review last discussion at 2013-11-21 TSC UDI Task Force
   • Review the updated spreadsheet, pattern document, and addenda to specify representation in V2, V3, etc.
     • UDI document always has a DI, and may contain a lot number and a serial number but the "serial_sup" in HIBCC doesn't actually exist separately from the "serial", notes Erin.
     • Christian confirms HIBCC has individual sub elements and sub-elements in combination. Supplemental serial number is used with an expiration date followed by lot number followed by (supplemental) serial number.
     • Paul will make the changes to the document and graphic and construct the package for out of cycle harmonization. He still needs some examples.
     • Christian notes that there are GS1 examples that start with a number and no brackets where there is no expiry date such as bandages or incontinence products that don't require batch numbers that are also devices. ISO 15459 reserves the first position 0-9 for GS1 identifiers. Paul will investigate further and try to get it resolved prior to the WGM; if not, review with Christian and Terri at the WGM. He'd like to try to get it harmonized before the WGM.
3. Adjourn 4:45 PM.

Next Steps

Actions (Include Owner, Action Item, and due date) .

Next Meeting/Preliminary Agenda Items

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