1. 1 October, 2015 HL 7 Working Group Meeting

2. FDA UDI Rule – 9/24/2013 Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use.. A unique device identifier is composed of: (1) A device identifier—a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and (2) A production identifier—a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device: (i) The lot or batch within which a device was manufactured; (ii) The serial number of a specific device; (iii) The expiration date of a specific device; (iv) The date a specific device was manufactured; (v) For an HCT/P regulated as a device, the distinct identification code required by § 1271.290(c) of this chapter.

3. Found on the device label, packaging or, in some cases, on the device itself Both in plain text and machine readable format (AIDC) - subset UDI = DI + PI Where is the UDI? UDI is subset of additional relevant data

4. International Medical Device Regulators Forum - IMDRF - Final UDI Guidance 12/9/2013 17. The bar code carrier(s) that includes UDI data identifiers “DI” and “PI” may also include essential data for the medical device to operate. The UDI issuing agencies identify these data elements by application identifiers or flag characters. The regulator shall not limit the use of the UDI carrier to only “DI” and/or “PI” data but allow for other relevant data. 4

5. Examples containing UDI Assumption: Able to scan and verify scan by reading information on the label Additional relevant data – Not UDI

6. Scanning and Interoperability Challenges Complexity of Scanning Interoperability Issues 6 Multiple Issuing Agency formats Inclusion of UDI + relevant data can result in ambiguity & AIDC* issues Relevant data not used by all HIT to ‘adequately identify the device’ Passing a variable string requires complex parsing rules for each transmitting system Not clear: transmit whole string or discrete fields or both? Time is NOW to clarify and articulate how to represent and transmit UDI *Automatic Identification Data Capture

7. On 10/24/15 All Class III All Implantable/Life Supporting/Life Sustaining Devices

8. HL7 UDI Task Force Recommendation Use full human readable string Ongoing discussions Initial adoption efferts Update: Need clarification and adjustment of original document to support UDI adoption 8

9. 4 Options for Transmitting UDI and other data Transmit the entire AIDC: – UDI and additional relevant information Transmit the entire human readable: – UDI and other information converted from AIDC and corrected to use braces Transmit each of the 6 identifiers that make up the UDI (device identifier, manufacturer date, expiration date, lot, serial, and distinct identification code). Note: convert dates to complete Gregorian and discarding extra data elements Transmit a string representing UDI and each of the 6 identifiers

10. Recommendation Transmit UDI [and relevant data?] via AIDC [or human readable?] string Transmit device identifier and 5 production identifiers as fully expressed discrete values (e.g. convert date)

11. Rationale for Recommendation Compromise – full string and inclusion of parts to provide flexibility to users Reduces downstream work of parsing Provides mechanism to validate parts with string Allows possiblity for inclusion of UDI and all relevant data 11

12. Next Steps Agree on format and extent of full string Determine level of readiness for each HL7 message to: Represent string Represent each of the 6 UDI identifiers* Device identifier Manufacturer date Expiration date Lot Serial Distinct identification code *Transform dates to complete Gregorian dates plus hour (CCYYMMDDHH) 12

13. References FDA UDI website http://www.fda.gov/UDI IMDRF Final UDI Guidance http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-udi- guidance-140901.pdf http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-udi- guidance-140901.pdf accessGUDID http://accessgudid.nlm.nih.gov/ HL7 Harmonization Document http://wiki.hl7.org/images/2/24/Harmonization_Pattern_for_Unique_Dev ice_Identifiers_20141113.pdf http://wiki.hl7.org/images/2/24/Harmonization_Pattern_for_Unique_Dev ice_Identifiers_20141113.pdf 2015-06-1613