2013-10-31 TSC UDI Task Force

TSC UDI TF

Meeting Info/Attendees

HL7 TSC Meeting Minutes Location: call 770-657-9270 using code 985371# GoToMeeting ID: 134-453-157		Date: 2013-10-31 Time: 4:00 PM U.S. Eastern DAYLIGHT
Facilitator: Paul Knapp		Note taker(s): Lynn Laakso

Quorum not defined
Attendee		role
x	Calvin Beebe	SDWG cochair
x	Woody Beeler	MnM cochairs, FTSD cochair
x	Hans Buitendijk	Siemens, OO cochair
x	Todd Cooper	DEV cochair
x	Gary Dickinson
x	Austin Kriesler	TSC Chair and Chief Instigator
x	Hugh Glover	Pharmacy cochairs, BlueWave
x	Matt Graham	Mayo, Mobile Health cochair
x	Grahame Grieve	FHIR FMG, MnM
x	Freida Hall	Quest and Project Services cochair
x	Allen Hobbs	KP, cochair of DEV
x	Wendy Huang	PA vocab facilitator, CGIT cochair
x	Julie James	BlueWave, IDMP coauthor
x	Paul Knapp	FTSD co-chair, UDI Task Force Chair, ITS and FM cochairs, FMG
x	Vince McCauley	SOA cochairs, IHE AUS
x	Behnaz Minaei	works with Terrie on UDI project
x	John Moehrke	GE, Security cochair, FMG, liaison to DICOM and IHE
x	JD Nolen	Cerner, AP cochair
x	Brian Pech	Publishing and FMG
x	Terrie Reed	FDA informatics and ONC with UDI incorporation into certification activieis
x	John Rhoads	cochair DEV
x	Abdul-Malik Shakir	Shakir Consulting, ACC Cardiology use of devices in cardiac care
x	Paul Schluter	with DEV and liaise with Continua and IHE PCP
x	Walter Suarez	KP, CQI cochair
x	Leslie Tompkins	FDA informatics
x	Pat Van Dyke	EHR cochair, ADentalA liaison

Agenda

Reviewed online

Minutes

Minutes/Conclusions Reached:

1. Roll Call
2. Review draft agenda
3. Introductions
4. Task Force:
   • Definition - a purpose tasked committee with a lifetime to match the issue
   • Objectives: to define a conceptual model for UDI to ensure interoperable implementation across the suite of HL7 standards (v2, v3 message4, v3 CDA, FHIR

   Timeline: 3 weeks if possible (prior to harmonization)

   • Goals for today: introduce the issue, outline the goal(s), start developing the questions, and engage participants in seeking the answer.
5. UDI Presentation from Terrie Reed (FDA)
   • UDI means Unique Device Identification. The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific medical device on the market. The UDI comprises the UDI-DI and UDI-PI.

   Note: The word Unique" does not imply serialization of individual production units.

   • Discussion: She shows a slide show on the current status of UDI.
   • Grahame asks if HL7 should be involved in the API development to the GUDID. How to retrieve from the GUDID not yet addressed.
   • Hans asks about the use cases for when to communicate UDI or its DI/PI components?
   • Paul Schluter notes that Terrie wanted ASCII string display. How must it be stored and displayed for EHRs - components versus the whole. If you break it up into constituent parts you can't reassemble it for human readable format with the PI at the manufacturer's discretion. Recommend communicating entire UDI as known and allow the application to parse / use what they need of it. User visual validation would require the parentheses to be displayed.
6. Questions (illustration)
   1. While the FDA is an issuer of UDIs, there are others internationally - do they all follow the same physical format, or formatting scheme (content type ID followed by the content)?
   2. Is the order of elements consistent?
   3. The UDI is composed of defined elements, is there a use case(s) for decomposition?
   4. Does the information in the BAR code match the PRINTED information and MATCH the values stored? for example:

      (01) 00643169001763(17) 160712 (21) 21A11F4855 - Printed

      (01)51022222233336(11)141231(17)150707(10)A213B1(21)1234 - Printed

      But the Lot number is variable length so this could be:

      Lot 'A213B1211234'

      Lot 'A' serial number '3B1211234'

      Lot 'A213B1' serial number '1234'

      .

      (01)0061414999996(17)199191(10)123ABC(21)1234567890 - Printed

      01006141419999961710010110123ABC211234567890 - Bar Code Reader

      ]C101006141419999961710010110123ABC<GS>211234567890 - others see

   • Good things:
     • Always transmit the entire string
     • The string should be human readable
     • The contents should be parseable
   • International device regulator's forum has been active for years and Terrie can refer to a white paper.
   • Paul K. describes use case with G10 example, vs ISBT format
   • Configuring bar code readers rendering same display values is an issue.
   • HL7 needs to specify what we're storing, knowing if it's a codeable structure and what the decoding would be. John M notes that there are OIDs, URIs and other universal global IDs but we don't try to decompose them.
   • Grahame notes he had investigated they will need to use specially configured bar code readers for this UDI. If we state the human-readable format is what needs to be exchanged because that is the format from which all can use it, since we need a separate bar code reader anyway.
   • Hans notes that an EI with assigning authority might indicate how the code is used. However when you're scanning how do you indicate that.
7. Next Steps:
   • At time, Paul is asked about inviting Christian Hay. This might be difficult time for him but we can invite him. What about HIBCC - Terrie can invite a contact. Hans asks about X12?
   • Schedule for next week at same time for next two weeks
   • Paul asks that others provide their perspectives, V2, FHIR, etc.
   • Woody sends the link to Grahame's Blog on UDI is: http://www.healthintersections.com.au/?p=1730
   • Grahame also asks about non-patient devices versus patient specific items like blood bags etc. John notes there are legacy identifiers in devices, like Continua notes JD.
8. Adjourned 5:16 PM

Next Steps

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

Next Meeting/Preliminary Agenda Items 2013-11-07 TSC UDI Task Force.

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