1 October, 2015 HL 7 Working Group Meeting

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 § (c) of this chapter.

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

International Medical Device Regulators Forum - IMDRF - Final UDI Guidance 12/9/ 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

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

10/5/15 Recommendation from Orders &Observations Transmit UDI and relevant data in human readable format Transmit device identifier and 5 production identifiers as fully expressed discrete values (e.g. convert date)

Next Steps 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) 7

10/24/15 All Class III All Implantable/Life Supporting/Life Sustaining Devices Time is NOW to clarify and articulate how to represent and transmit UDI

UDI in ONC/CMS Rules Edition Health IT Certification Criteria, 2015 Edition Base EHR Definition, and ONC Health IT Certification Program Modifications Section (a)(14) Implantable device list Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 3 and Modifications to Meaningful Use in 2015 through

Link the Device with the Patient Create an Implantable device list: Record the UDIs associated with a patient’s implantable device list Expect that health IT developers and heath care organizations will implement AIDC capabilities Allow UDIs to be exchanged among “downstream” health IT systems and accessed by clinicians wherever patients seek care. 12

Health IT Requirements Accept the UDI (manual or AIDC) Break up/Parse the UDI into: Device Identifier Lot/Batch Serial number Expiration date of a specific device; Date of Manufacturer Distinct identification code required by 21 CFR § (c). 13

Use DI to “accessGUDID” Use device identifier to pull core attributes: Company Name Brand Name Version or Model Patient Safety Information What MRI safety information does the labeling contain?; and Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR ). 14

Use DI to “accessGUDID” Use device identifier to pull core attributes A description of the implantable device using one of the following: Global Medical Device Nomenclature Preferred Term Name or; Systemized Nomenclature Of Medicine- Clinical Terms ® Description 15

Benefits to Patients/Providers Display of an implantable device list consisting of active implantables: *Device Identifier, Expiration Date, Manufacturing Date, Lot, Serial, Distinct Identification Code 16 UDI*Description (GMDN or SNOMED) Company Name Brand Name Model or Version MRI SafeLabeled Containing Latex

Additional Features Ability to Change status of UDI: Active vs. Inactive Inclusion of UDI in Common Clinical Data Set (CCDS) requirements 17

References 2015 ONC EHR Certification Criteria - unpublished /2015-edition-health-information-technology- certification-criteria-2015-edition-base-electronic /2015-edition-health-information-technology- certification-criteria-2015-edition-base-electronic FDA UDI website IMDRF Final UDI Guidance udi-guidance pdf udi-guidance pdf accessGUDID HL7 Harmonization Document Unique_Device_Identifiers_ pdf Unique_Device_Identifiers_ pdf 18