GS1 & Supply Chain

Healthcare GS1 Standards: GTIN, AIDC & UDI Compliance

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GS1 standards for healthcare: GTIN on medical products, AIDC in clinical settings, and how GS1 barcodes meet FDA and EU MDR UDI requirements.

  
  

    
  








  
  

    
    
      
      
  1. 
        Healthcare GS1 Standards: GTIN, AIDC &amp; UDI Compliance
      
    2. 
      
      
  2. 
        The UDI Framework
      
    3. 
      
      
  3. 
        UDI Encoding
      
    4. 
      
      
  4. 
        AIDC in Clinical Settings
      
    5. 
      
      
  5. 
        The Five Rights
      
    6. 
      
      
  6. 
        GS1 Healthcare Keys
      
    7. 
      
      
  7. 
        Regulatory Requirements
      
    8. 
      
      
  8. 
        Implementation Considerations
      
    9. 
      
    

  









  
  

  
  

    
    

      
Healthcare GS1 Standards: GTIN, AIDC & UDI Compliance


Healthcare is one of the most barcode-intensive industries, with barcodes on every drug package, medical device, blood product, and patient wristband. GS1 standards provide the framework for healthcare barcode identification, mandated by regulators worldwide.


The UDI Framework


Unique Device Identification (UDI) requires that every medical device carries a barcode with:


    

  • Device Identifier (DI): The GTIN that identifies the product model
    • 

  • Production Identifier (PI): Variable data including serial number, lot number, expiration date, and manufacturing date
    • 



Together, DI + PI create a unique identifier for each individual device unit.


UDI Encoding


UDI data is encoded in GS1 DataMatrix or GS1-128:


(01)00860001234567(17)260630(10)LOT123(21)SER456
     GTIN/DI           Expiry     Lot        Serial



Data Matrix with GS1 AIs for pharma and food traceability." data-category="2D & Matrix Symbologies">GS1 DataMatrix is preferred for small devices and pharmaceutical unit-dose packaging. GS1-128 is used on case and pallet labels.


AIDC in Clinical Settings


Automatic Identification and Data Capture (AIDC) in hospitals uses barcodes for:






Application
Barcode Type
Purpose






Patient ID
Code 128 on wristband
Verify patient identity




Medication
GS1 DataMatrix on package
Match drug to order




Blood product
ISBT 128 on bag
Verify blood type match




Specimen
Code 128 or Data Matrix on tube
Link specimen to patient




Instrument
Data Matrix DPM
Track surgical tools






The Five Rights


Barcode-assisted medication administration (BCMA) enforces the "five rights":


    

  1. Right patient: Scan wristband to verify identity
    2. 

  2. Right drug: Scan medication package to verify drug name and strength
    3. 

  3. Right dose: System checks scanned drug against prescribed dose
    4. 

  4. Right route: System displays administration route
    5. 

  5. Right time: System validates timing against schedule
    6. 



Studies show BCMA reduces medication errors by 50-80%.


GS1 Healthcare Keys






Key
Identifier
Use






GTIN
Product/device
Identify each product model




GLN
Location
Identify hospitals, departments, pharmacies




SSCC
Logistics unit
Track shipments to hospitals




GSRN
Patient
Global Service Relation Number for patient ID






Regulatory Requirements






Regulation
Region
Requirement






FDA UDI
US
GS1 or HIBCC barcodes on all medical devices




EU MDR
Europe
UDI-DI in EUDAMED database




DSCSA
US
Serialization of pharmaceutical packages




EU FMD
Europe
Serialized 2D barcodes on prescription drugs






Implementation Considerations


    

  • Work with your GS1 Member Organization's healthcare team for guidance
    • 

  • Register products in GUDID (FDA) or EUDAMED (EU) databases
    • 

  • Test barcode quality against ISO/IEC 15415" data-definition="International standard for 2D barcode print quality grading." data-category="Printing & Quality">ISO/IEC 15415 for 2D and ISO/IEC 15416 for 1D
    • 

  • Coordinate with hospital systems to ensure barcode data is parsed correctly
    • 

  • Consider GS1 DataMatrix for small packages and direct part marking
    •