GTIN (Global Trade Item Number) and UDI (Unique Device Identification) are two systems designed to track and manage products efficiently. Although they share fundamental functions, they are often confused due to their overlapping roles in product identification.
This article aims to delineate the specific uses and benefits of GTIN and UDI, highlighting how they cater to different regulatory and operational needs within diverse industries.
GTIN, or Global Trade Item Number, is an international identifier used to mark and track products in supply chains. This system is developed by GS1 and assigns a unique number to each item that is sold, stored, or transported.
GTIN helps streamline supply chain operations from manufacturing to point of sale. GTINs are embedded in barcodes and scanned throughout logistics networks to monitor product movements and manage inventory effectively.
GTIN has four types.
Unique Device Identification (UDI) is a system that marks and identifies medical devices within the healthcare sector. Each UDI is a unique alphanumeric code and includes specific information about the device. This information consists of the manufacturer, product ID, and production identifier, including the lot or batch number, serial number, expiration date, or manufacture date.
UDI comprises a Device Identifier (DI) and a Production Identifier (PI).
The Device Identifier (DI) specifies the labeller and the specific model or version of a device. The Production Identifier (PI) provides the lot or batch number, serial number, and expiration date.
UDI code is typically presented in two forms.
The main objectives of the UDI system are to reduce medical errors linked to device misidentification, simplify the management of medical device recalls, enhance the effectiveness of the medical device supply chain, and provide a foundation for a secure global distribution chain.
UDI and GTIN share several foundational similarities, such as.
Both UDI and GTIN are formulated under the auspices of GS1. GS1 is a global entity that develops and maintains standards for tracking and tracing supply and demand chains across various industries.
This standardisation ensures that products and devices are identifiable worldwide, facilitating international commerce and healthcare operations.
Both UDI and GTIN significantly enhance the traceability of products within their respective sectors.
UDI facilitates detailed tracking of medical devices, which is crucial for recall accuracy and patient safety. Similarly, GTIN enables the efficient tracing of consumer goods across global supply chains.
UDI and GTIN both play pivotal roles in meeting stringent regulatory standards within their fields.
UDI compliance is mandatory for medical devices, dictated by global health authorities such as the FDA and EMA.
GTIN, on the other hand, adheres to regulations that streamline commerce and trade worldwide.
UDI and GTIN seamlessly integrate with contemporary technological systems, enhancing operational efficiency and data management.
UDI supports integration with health IT systems, including electronic health records (EHRs), which helps streamline patient care and device management.
Similarly, GTIN integrates with retail and supply chain management systems using barcode and RFID technologies.
While UDI and GTIN share foundational similarities, they are designed for different purposes and sectors, which leads to several key differences:
Difference | UDI (Unique Device Identification) | GTIN (Global Trade Item Number) |
|---|---|---|
Scope of Application
| Targets medical devices in healthcare. Tracks from production to patient use.
| Broadly used across industries for consumer goods identification.
|
Regulatory Requirements
| Stringent compliance with healthcare rules by FDA (Food and Drug Administration), and MDR (Medical Device Reporting).
| Follows regulations primarily related to trade and inventory control, with less emphasis on safety.
|
Composition | Includes DI for model-ID and PI for batch/serial numbers.
| Comprises company prefix, item reference, and check digit.
|
Traceability and Data Depth
| Detailed traceability for safety, includes expiration dates.
| General inventory and sales tracking; less detailed.
|
Purpose and Impact
| Ensures medical device safety and regulatory compliance.
| Enhances supply chain efficiency and retail management.
|
Stakeholder Engagement
| Involves healthcare providers, regulators, and patients.
| Engages manufacturers, retailers, and consumers.
|
The scope of application for UDI and GTIN distinctly separates their operational fields.
UDI is specifically designed for use within the healthcare industry, and applied to medical devices to ensure safety and regulatory compliance.
On the other hand, GTIN is broadly used across retail, logistics, and e-commerce, for general product identification.
UDI and GTIN face different regulatory landscapes tailored to their applications.
UDI adherence is mandated by stringent health regulations due to its use with medical devices. Compliance is monitored by global health authorities, such as the FDA in the U.S. and EMA in Europe.
Conversely, GTIN compliance primarily addresses commercial and trade standards. These regulations are overseen by GS1 and are less strict than those in healthcare.
UDI’s composition is tailored for medical device specificity. It includes a Device Identifier (DI) and a Production Identifier (PI). DI identifies the maker and model, ensuring device traceability. PI details production specifics like batch or serial numbers and expiration dates. This composition is crucial for health safety and regulatory tracking.
Conversely, GTIN’s structure is uniform across various sectors. It consists of a GS1 prefix, an item reference, and a check digit. The format varies by length to accommodate different packaging needs and regional standards.
UDI offers in-depth traceability that is vital for medical devices. It includes critical data like expiration dates and detailed production histories.
GTIN provides general traceability data primarily used for inventory control and sales tracking.
UDI is designed to enhance patient safety and ensure regulatory compliance within the healthcare sector. It supports precise tracking and management of medical devices, which is critical for effective patient care.
On the other hand, GTIN’s primary purpose is to improve supply chain efficiency and retail management. It facilitates the seamless flow of goods through markets and simplifies inventory processes.
UDI involves a diverse array of healthcare stakeholders, including medical device manufacturers, healthcare providers, regulatory bodies, and patients.
Conversely, GTIN engages primarily commercial stakeholders such as manufacturers, distributors, retailers, and consumers.
Understanding the differences between GTIN and UDI is crucial for enhancing supply chain efficiency and ensuring healthcare safety. While GTIN broadens supply chain management across various sectors, UDI focuses on improving traceability and safety in healthcare.
Both identification systems are vital for their respective fields, ensuring compliance and operational effectiveness.
We hope this article has clarified the distinct roles and benefits of GTIN and UDI, aiding your decision-making process.
Thank you for reading!
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