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October, 2015HL 7 Working Group Meeting

FDA UDI Rule – 9/24/2013Unique 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.

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 = UDI = DIDI + + PIPI

Where is the UDI?Where is the UDI?

UDI is subset of additional relevant data

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.

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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 StepsDetermine level of readiness for each HL7

message to: Represent stringRepresent 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)

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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 - 20152015 Edition Health IT Certification Criteria,

2015 Edition Base EHR Definition, and ONC Health IT Certification Program ModificationsSection 170.315(a)(14) Implantable device list

Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 3 and Modifications to Meaningful Use in 2015 through 2017

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Link the Device with the Patient

Create an Implantable device list: Record the UDIs associated with a patient’s

implantable device listExpect that health IT developers and heath care

organizations will implement AIDC capabilitiesAllow UDIs to be exchanged among

“downstream” health IT systems and accessed by clinicians wherever patients seek care.

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Health IT RequirementsAccept the UDI (manual or AIDC)Break up/Parse the UDI into:

Device IdentifierLot/BatchSerial number Expiration date of a specific device; Date of ManufacturerDistinct identification code required by 21 CFR §

1271.290(c).

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Use DI to “accessGUDID”

Use device identifier to pull core attributes:Company NameBrand NameVersion or ModelPatient 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 801.437).

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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

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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

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UDI* Description

(GMDN or SNOMED)

Company Name

Brand Name

Model or Version

MRI Safe Labeled Containing Latex

Additional FeaturesAbility to Change status of UDI: Active vs.

InactiveInclusion of UDI in Common Clinical Data Set

(CCDS) requirements

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References2015 ONC EHR Certification Criteria - unpublished

https://www.federalregister.gov/articles/2015/10/16/2015-25597/2015-edition-health-information-technology-certification-criteria-2015-edition-base-electronic

FDA UDI websitehttp://www.fda.gov/UDI

IMDRF Final UDI Guidancehttp://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-udi-

guidance-140901.pdfaccessGUDID

http://accessgudid.nlm.nih.gov/HL7 Harmonization Document

http://wiki.hl7.org/images/2/24/Harmonization_Pattern_for_Unique_Device_Identifiers_20141113.pdf

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