In this article, we explore what UDI barcodes are and their components and purposes. We also share the primary standards for issuing UDI barcodes for global use.
What is a UDI Barcode?
A UDI (Unique Device Identification) barcode is a specialized barcode used in the Unique Device Identification system to provide essential details about a medical device such as its unique identifier, expiration, and manufacturing dates. These barcodes ensure precise tracking and traceability to aid healthcare professionals and regulators in quick and accurate identification and enhance healthcare system efficiency and safety, especially during recalls or adverse events.
In this example, "UDI-123456789" represents the unique identifier for the medical device. The expiration date is "2023-12-31", and the manufacturing date is "2022-05-15". This information is encoded within the UDI barcode, allowing healthcare professionals and regulators to quickly access essential details about the device.
Key Components of a UDI Barcode
A UDI (Unique Device Identification) barcode consists of two main parts:
Device Identifier (DI):
This is a unique code assigned to a specific model or version of a medical device. It identifies the manufacturer and the specific version or model of the device.
In this example, "A1B2C3D4E5F6" represents the unique code assigned to a specific model or version of a medical device, indicating the manufacturer and the device's specific version.
Production Identifier (PI):
The Production Identifier contains information such as the lot or batch number, expiration date, manufacturing date, and, if applicable, the serial number of the device. These details provide specific information about the production history and usage of the device.
Example Lot Number: 12345 Example Expiration Date: 20231231 (December 31, 2023) Example Manufacturing Date: 20220115 (January 15, 2022) Example Serial Number: 6789
In this example, the Production Identifier includes the lot or batch number ("12345"), expiration date ("20231231"), manufacturing date ("20220115"), and serial number ("6789"). These details provide specific information about the production history and usage of the device.
Key Purposes of UDI Barcodes
The Unique Device Identification (UDI) barcode system serves several crucial purposes in the healthcare industry:
Patient Safety: UDI barcodes help in accurately identifying and tracking medical devices, ensuring that patients receive the correct devices, reducing the risk of errors, and improving overall patient safety.
Traceability: UDIs allow for precise tracking of devices throughout their entire lifecycle - from manufacturing to distribution, to usage, and even post-market surveillance. This traceability is crucial for managing recalls, investigating adverse events, and ensuring the quality of devices in the market.
Efficient Recalls: In the event of a defective or dangerous device, UDI barcodes enable targeted recalls. Identifying specific batches or models becomes swift, minimizing the impact on patients and reducing costs for manufacturers.
Regulatory Compliance: Regulatory bodies in various countries, such as the FDA in the United States and the European Medicines Agency (EMA) in the EU, require medical devices to carry UDIs. Compliance with these regulations is essential for market access.
Improved Data Accuracy: Automation through barcode scanning reduces human errors, ensuring accurate data about devices is collected and stored in electronic health records and other healthcare systems.
Supply Chain Efficiency: UDIs streamline inventory management, making it easier for healthcare providers to manage stock levels, reorder devices, and reduce waste, ultimately leading to more efficient supply chains.
Research and Development: Accurate and detailed data collected through UDIs can be utilized for research and development purposes, enabling manufacturers and regulators to make informed decisions about device safety and efficacy.
Healthcare Cost Reduction: By reducing errors, improving recall efficiency, and optimizing supply chains, UDI implementation can potentially lead to cost savings in the healthcare system.
Primary Standards of UDI Barcodes
The standards for UDI (Unique Device Identification) barcodes are set by international organizations and regulatory agencies to ensure consistency and interoperability across the healthcare industry. The primary standards for UDI barcodes include:
GS1 is a global organization that develops and maintains standards for supply chains, including healthcare. They have established standards for both linear and 2D barcodes. GS1 standards are widely used in various industries, including healthcare, to ensure the uniqueness and accuracy of product identification.
The International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) jointly develop standards for various technologies, including barcoding. ISO/IEC standards ensure the quality and compatibility of barcodes across different applications. ISO/IEC 15459 specifies the Data Matrix symbology, which is commonly used for UDI in the healthcare sector.
Health Industry Bar Code (HIBC) Standards:
HIBC is a non-profit organization that develops standards for barcoding in the healthcare industry. HIBC barcodes are alphanumeric and are used to encode manufacturer and product information, including lot numbers and expiration dates.
FDA UDI Rule:
In the United States, the FDA has specific regulations and guidelines for the implementation of UDI, including barcode standards. Manufacturers of medical devices are required to comply with FDA UDI regulations to ensure that their products are properly marked and identified.
We hope our article has now left you with a better understanding of UDI barcodes, their uses in the healthcare industry, and the most recognized global standards of UDI barcodes.