HIBC or GS1
The free choice of UDI
The key requirement in the UDI compliant labeling is a unique identifier of the product and its production data. This is achieved by applying a Vendor plus a product identifier.
In many areas, the UDI specification is open, so you can select the data structure (eg, GS1 or HIBC) and also the barcode type (eg Code 128 or DataMatrix). Your choice will set the use of the Data Identifier (ANSI) or the Application Identifier (GS1).
For a simple UDI compliant labeling our PRISYM Design software provides the necessary functions. If you need a complete FDA validatable solution, then PRISYM 360 is the optimal software package on the market.
The Barcode Symbologies
Although different barcode symbologies allowed under UDI (Code39, Code128, DataMatrix, QR Code), you will probably have to deal most with the Code128 and for the 2D barcodes with the Data Matrix. Only when using the HIBC the Code 39 still plays a role.
Depending on the data structure, the Application Identifiers (GS1) or the Data Identifier (ANSI/HIBC) will be used in the barcode. PRISYM Design supports you through a wizard when using the Application Identifier for GS1 compliant layouts and allows the creation of HIBC barcodes.
GS1-128When using GS1-128 the important data such as product ID, manufacturer and lot number usually set via the identifiers (01) GTIN, (10) BATCH / LOT and (11) PROD DATE. Optionally (30) VAR count and (17) used by date is sometimes used. The GS1-128 uses special characters, such as the FNC1 or font switching tags.
GS1-DatamatrixThe data structure in the GS1 DataMatrix is identical to the GS1-128, so that the information also apply here. The error correction in the data matrix is fix ECC200 and must be set accordingly. Since the Data Matrix has no human readable text, the readable plain text HRI must be present somewhere on the label. The GS1 structure is consistent and easy to understand.
HIBCWithin HIBC the symbologies Code 128, Data Matrix or Code 39 could be used. It offers similar GS1 information such as manufacturer, product, quantity, lot/serial number and expiration date. If additional information is required in the barcode, Data Identfier must be inserted according to ANSI. The HIBC provides an alphanumeric product ID if compared against GS1.
The global UDI Database
The global UDI database collects product data for medical products of all 3 classes. As a product reference the respective UDI identifier of the product is used and this identifier is also used in the exchange of data with the UDI database. The interface for this exchange of data is defined via the HL7 standard.
Currently 21 items are transferred to the UDI database and this includes product information, information on the manufacturer, storage and quantities as well as some product features like information for sterilization and packaging.
Also note the important Dates to implement the UDI guidelines. The next important one is 09-2016 for reusable class II products and 09-2018 for all Class I and unclassified products. And in September 2020, all medical devices have to be labelled according to UDI.
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