Health Care
Standards Organizations
Two major standards organizations regulate barcode usage in the health care industry: HIBCC and GS1.
The Health Industry Business Communications Council (HIBCC) was established to develop a standard for barcodes to be used to improve patient safety and increase supply chain efficiency. This standard, the Health Industry Bar Code (HIBC) standard, was developed in 1983 and has expanded in scope to include several areas of overview. HIBC standards adhere to and are referenced by several American National Standards Institute (ANSI), and International Organization for Standardization and International Electrotechnical Commission (ISO and IEC) standards.
Health care industry barcode standards include the following:
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ANSI MH10.8.2 American National Standard - Data Identifier and Application Identifier Standard
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ANSI/HIBC 2.6 The Health Industry Supplier Labeling Standard for Patient Safety and Unique Device Identification (UDI)
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ANSI/HIBC 5.0 The Health Industry Bar Code (HIBC) Syntax Standard
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ANSI/HIBC 3.1 Positive Identification for Patient Safety Part 1: Medication Delivery
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ANSI/HIBC 1.3-2010 The Health Industry Bar Code (HIBC) Provider Applications Standard
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ANSI/HIBC 4.0 The Health Industry Supplier Standard for RFID Product Identification
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ISO/IEC 15415 Information technology - Automatic identification and data capture techniques - Bar code print quality test specification - Two-dimensional symbols
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ISO/IEC 15416 Information technology - Automatic identification and data capture techniques - Bar code print quality test specification - Linear symbols
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ISO/IEC 15417 Information technology - Automatic identification and data capture techniques - Code 128 bar code symbology specification
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ISO/IEC 16022 Information technology - Automatic identification and data capture techniques - Data Matrix bar code symbology specification
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ISO/IEC 16388 Information technology - Automatic identification and data capture techniques - Code 39 bar code symbology specification
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ISO/IEC 18004 Information technology - Automatic identification and data capture techniques - QR Code bar code symbology specification
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ISO/IEC 24778 Information technology - Automatic identification and data capture techniques - Aztec Code bar code symbology specification
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ISO/IEC 29158 Information technology - Automatic identification and data capture techniques - Direct Part Mark (DPM) Quality Guideline
HIBC standards are accredited by ANSI in the US and by the European Committee for Standardization (CEN) in Europe. They are also referred to in various ISO standards that are related to the labeling of health care products and devices.
The standards call for an alphanumeric identification system that can be encoded by the following symbologies:
The international GS1 organization established a health care industry group called GS1 Healthcare whose purpose is to encourage the adoption and implementation of existing GS1 standards in the health care industry. GS1 Healthcare and its US member organization, GS1 Healthcare US, have recommended that the industry adopt the use of GS1 Global Location Numbers (GLNs) for location identification, GS1 Global Trade Item Numbers (GTINs) for product information, and Serial Shipping Container Code (SSCC) for shipping information. These numbers can be encoded by using the following symbologies:
GS1 barcode standards define GS1-128, GS1 DataMatrix, and GS1 DataBar, which are GS1-specific versions of the Code 128, Data Matrix, and Data Bar symbologies that are based on ISO/IEC standards.
FDA UDI
In 2013, the US Food and Drug Administration (FDA) issued a final rule to establish a system to label medical devices that are sold in the US with a unique device identifier (UDI). Additionally, labelers must submit product information about the devices to the FDA's Global Unique Device Identification Database (GUDID), unless they are subject to an exception or alternative. The system that was established by this rule requires that the label and package of each device include a UDI in a human-readable form and in a form that uses automatic identification and data capture (AIDC) technology, such as barcodes.
The UDI is a unique numeric or alphanumeric code that includes a device identifier (DI), which is specific to a device model, and a production identifier (PI), which includes production information for that specific device, such as the manufacture date, the lot or batch number, the serial number, and/or the expiration date. The rule does not require a specific barcode or AIDC technology.
Three issuing agencies have been accredited by the FDA to assign UDIs:
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HIBCC: Uses its primary data structure for the DI and its secondary data structure for the PI
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GS1: Uses its GTIN as the DI and its Application Identifiers (AIs) as the PI
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International Council for Commonality in Blood Banking Automation (ICCBBA): Uses specific data structures, as defined in the International Society of Blood Transfusion (ISBT) 128 standard, to encode the DI and PI
Each agency uses a different format for its version of the UDI, but they all encode at least a device identifier and lot number together with supplemental production information.
The primary data structure (DI) that is encoded in the HIBCC UDI barcode is defined by the HIBC 2.6 standard and consists of the following elements:
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Flag character (+)
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Four-character Labeler Identification Code (LIC), assigned by HIBCC
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One-character to 18-character Product or Catalog Number (PCN) that identifies the product
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One-digit Unit of Measure identifier (U/M)
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Check digit (modulo 43)
The secondary data structure (PI) that is encoded in the HIBCC UDI barcode is also defined by the HIBC 2.6 standard and consists of the following elements:
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Flag character (+)
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Variable-length field for quantity and/or date
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Zero-character to 18-character field for lot, batch, or serial number
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One-digit link character
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Check digit (modulo 43)
If necessary, these codes can be concatenated into one symbol by using a forward slash (/) as a delimiter.
To comply with FDA UDI requirements by using the HIBCC system, labelers must:
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Register with HIBCC to get an LIC.
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Use the HIBC 2.6 standard to create HIBC barcodes and UDIs.
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Request a GUDID account from the FDA.
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Obtain software to create barcodes for the UDIs.
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Use the HIBCC UDI Decoder app to scan the HIBCC Auto-ID symbols that are created by the software. The app identifies the elements to be sent to the GUDID database.
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Submit the DI segment of the UDI to the GUDID.
The FDA accreditation allows GS1 to indicate that its GTIN and AIs together constitute a UDI.
To comply with FDA UDI requirements by using the GS1 system, labelers must:
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Obtain a GS1 Company Prefix and create a numbering system for product and logistics information.
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Use the GS1 standards and procedures to create barcodes and UDIs.
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Request a GUDID account from the FDA.
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Obtain software to create barcodes for the UDIs.
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Submit the DI segment of the UDI to the GUDID by using the GS1 Global Data Synchronisation Network (GDSN).
The ICCBBA UDI implementation is defined in ICCBBA ST-011 Coding and Labeling of Medical Devices Using ISBT 128. This standard defines the various ISBT 128 data structures that are used to fulfill the UDI requirements.
For the DI, the ISBT 128 standard specifies that Data Structure 034 (Processor Product Identification Code) is used. This data structure includes the facility identification number (FIN), a facility-defined product code (FPC), and a product description code (PDC).
For the PI, the ISBT 128 standard specifies that the following data structures are required:
If expiration date, manufacturing date, or lot number are included on the label, the corresponding data structures must also be included in the PI code, as follows:
Data Structure 004 (Expiration Date) for the expiration date
Data Structure 008 (Production Date) for the manufacturing date
Data Structure 035 (MPHO Lot Number) for the lot number
ISBT 128 also specifies that the DI and PI should be included together in a compound message that is encoded in a single barcode symbol. To do this, Data Structure 023 (Compound Message) is used.
To comply with FDA UDI requirements by using the ICCBBA system, labelers must:
Register their facility with ICCBBA and be assigned a unique FIN.
Use the ISBT 128 standard to create UDIs.
Request a GUDID account from the FDA.
Obtain software to create barcodes for the UDIs.
Submit the DI segment of the UDI to the GUDID.
HIBCC Standards