ISO/IEEE 11073 Support for UDI January, 2017 IEEE/HL7 San Antonio, USA

FDA UDI The FDA have proposed a labelling format (human and machine (ie scanned) readable) to provide all medical devices with a unique identifier (UDI). Currently the UDI are to be managed by appointed labelling authorities such as GS1, each of which has proposed its own label format. Starting point http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ FAQ http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM410439.pdf Full text https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system#h-75

FDA UDI A UDI is a unique numeric or alphanumeric code that consists of two parts: A device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and A production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device: the lot or batch number within which a device was manufactured the serial number of a specific device the expiration date of a specific device the date a specific device was manufactured the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device

FDA UDI – labeling agencies Issuing Agency Data Delimiters Identifier Data type Human Readable Field Size Database GS1 (01) Device Identifier (DI) numeric 16 14 (11) Manufacturing/ Production Date Numeric [YYMMDD] 8 6 (17) Expiration Date numeric [YYMMDD] (10) Batch/Lot Number alphanumeric 22 20 (21) Serial Number Maximum Base UDI 76 66 Example of GS1 easily readable plain-text UDI: (01)51022222233336(11)141231(17)150707(10)A213B1(21)1234 Note: the agencies have not adopted a consistent label format

Representation in HL7 HL7 (V2.8) supports FDA UDI by allowing both the full label text in PRT-10 and the components in PRT-16 through PRT22 PRT-10 Full text label for FDA-UDI (string) PRT-16 Participation Device Identifier (string) PRT-17 Participation Device Manufacture Date (Date-string?) PRT-18 Participation Device Expiry Date (Date-string?) PRT-19 Participation Device Lot Number (String) PRT-20 Participation Device Serial Number (String) PRT-21 Participation Device Donation Identification (String) - relates to donation of blood etc PRT-22 Participation Device Type (string)

IEEE 11073 UDI -- UDISpec supports the encoding of unique identities such as the US FDA UDI [B27]. UDISpec ::= SEQUENCE OF UDISpecification UDISpecification ::= SEQUENCE { udi-authority UdiAuthority, udi-issuer UdiIssuer, udi-content UDIContent } UdiAuthority ::= ITU-OID; -- Identifies the jurisdictive organization for the UDI, such as the US FDA. -- The US FDA’s OID is 2.16.840.1.113883.3.24 UdiIssuer ::= ITU-OID; -- Organization that is charged with issuing UDIs for devices. -- For example, the US FDA issuers include: -- GS1, HIBCC and ICCBBA -- An OID value of “0” should be used if the issuer is unknown or not recorded in the -- device.

IEEE 11073 UDI ITU-OID ::= OCTET STRING -- a OID can be used as an unique identifier for an organization -- OID trees are maintained by registration authorities with ITU-T and ISO at the top; -- HL7 manages an OID tree; -- see http://oid-info.com/index.htm

IEEE 11073 UDI UDIContent ::= SEQUENCE OF UDIContentElement UDIContentElement ::= SEQUENCE { udi-element-type INT-U16 { udi(10), -- full text label for the UDI – can be mapped to HL7 v2.8 [B26] udi PRT10 -- matches the human readable UDI string that is part of the labeling of the device udi-device-identifier(16), -- a numeric or alphanumeric value assigned to a model -- or version of a medical device by an UDI authority – the DI part of a UDI -- can be mapped to HL7 v2.8 participation device identifier PRT16 udi-device-manufacture-date(17), -- A date determined by the Regulated Entity in which the medical -- device is considered manufactured - in ISO 8601 extended format YYYY-MM-DD -- can be mapped to HL7 v2.8 Participation Device Manufacture Date PRT17

IEEE 11073 UDI udi-device-expiry-date(18), -- The date and time beyond which this device is no longer valid -- or should not be used (if applicable) – in ISO 8601 extended format YYYY-MM-DD -- can be mapped to HL7 v2.8 PRT18 udi-device-lot-number(19), -- Lot number assigned by the manufacturer. Can be mapped to HL7 v2.8 PRT19 udi-serial-number(20), -- the serial number of the device - maps to HL7 v2.8 PRT20 -- typically the same as the serial number in the production specification (if present) udi-distinct-identification(21), -- Part of the production identifier used to identify HCT/Ps (Human cells, tissues, and -- cellular and tissue-based products) -- maps to HL7 v2.8 PRT21, included here for completeness udi-device-type(22) -- the device type coded using the code system of the issuer - maps to HL7 v2.8 PRT22 -- HL7 v2.8 requires use of PRT-10 when serial number is present and not in PRT-22. }, udi-element OCTET STRING -- string size shall be even }