1. Integrating the Healthcare Enterprise (IHE) Patient Care Device Domain (PCD) FDA UDI Considerations IHE PCD 2013 Fall F2F, Boca Raton, FL
Monroe Pattillo
Practical Health Interoperability, LLC
Fort Lauderdale, FL, USA
IHE Patient Care Devices Domain
Planning Committee Co-Chair
© 2013 ACCE, HIMSS, IHE

2. PCD FDA UDI Considerations
FDA released final guideline on UDI
Deadlines in guideline (1yr implants, 2yrs others)
UDI based upon ISO Unique Identifiers
FDA GUDID requires only DI portion of UDI
DI not device instance unique
PI portion of UDI to be tracked by hospital
Full FDA UDI (DI+PI) contains special characters
Guideline expects full UDI used in CMMS & recalls
Guideline offers no help mapping UDI to HL7 v2.6
PCD requires EUI-64 & UDI DI + SN in messages
Final mapping determination by HL7 Ords & Obs
PCD should develop an opinion whitepaper ASAP 2

3. A PCD means of including UDI DI & SN
FDA deadlines – Need means of mapping DI + SN in HL7 v2.6
Communicating full UDI (DI+PI) would require new HL7 data type (FDA UDI) to accommodate special characters in UDI
FDA guideline hints that UDI registering agencies likely to be GS1 and HIBCC, possibly others
GS1 GTIN – low cost, short lived items (consumables)
GS1 GIAI – high cost, long lived items (medical devices)
Registered OID exists for GS1 GIAI ( giai.sn)
Using GIAI as DI could allow PCD to use EI data type to map a GS1 GIAI.SN to ISO dot notation
HIBCC & others could register an OID to map their values
Usable in HL7 v2.6 OBX-18 equipment field (PRT-10 in v2.7)
PCD TF EUI-64 in 1st occurrence, GIAI in 2nd occurrence
Could be basis for whitepaper to HL7 Ords & Obs 3

4. HL7 v2.6 Basis for DI+SN mapping
HL7 data type is EI – Entity Identifier, containing the following components
EI comp 1 – Identifier (HL7 2.A.25)
Entity Identifier (ST) GIAI_value.serialno
Assigning Authority or Assigning Facility, HD (Hierarchic Designator) data type (HL7 2.A.33)
EI comp 2 (HD comp 1) - Namespace ID (IS) empty
EI comp 3 (HD comp 2) - Universal ID (ST) GIAI dot notation
EI comp 4 (HD comp 3) - Universal ID Type (ID) ISO 4

5. HL7 v2.6 Mapping Example
Following assumes GS1 as assignor. Similar workup needed for other assignors, e.g. HIBCC. If HIBCC would register an OID for value communication that would be appreciated.
Example:
ABC12345^^ ABC12345^ISO
Where
“876543” is UPC assigned to manufacturer for product (essentially DI)
Zero “0” added to UPC Company Prefix to make GS1 Company Prefix
“ABC12345” is manufacturer assigned product instance serial number (not the entire PI)
“ ” OID established by GS1 for communication of GIAI value
See for details 5

6. Next Steps Use PCD TC WG to verify that mapping is workable
Develop whitepaper
Ballot the whitepaper (might make sense)
Pass whitepaper up to ITI for their assessment
Change as needed for ITI comments
Pass whitepaper to HL7 Ords & Obs as the PCD recommended solution
Do it all ASAP to avoid solution handed to PCD 6