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

2. 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
FAQ
Full text

3. 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 § (c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device

4. 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) (11)141231(17)150707(10)A213B1(21)1234
Note: the agencies have not adopted a consistent label format

5. 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)

6. IEEE 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
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.

7. 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

8. 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

9. 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 }