The GS1 Advantage for Medical Device

What is GS1?

GS1 is a global non-profit organization that develops and maintains standards for the identification, capture, and sharing of product-related information. In healthcare, GS1 standards have had a significant impact by improving efficiency, accuracy, and traceability across the entire supply chain. The implementation of GS1 standards involves assigning unique identifiers, such as Global Trade Item Numbers (GTINs), to medical products and devices.

The impact of GS1 in Healthcare includes:

• Patient Safety: GS1 standards enhance traceability, helping to reduce the risk of counterfeit or substandard medical products. Patients benefit from increased safety and confidence in the authenticity of the medications and devices they receive.
• Supply Chain Efficiency: GS1 standards enable seamless communication and information exchange between different stakeholders in the healthcare supply chain. This leads to improved inventory management, reduced errors, and streamlined logistics processes, ultimately lowering costs.
• Regulatory Compliance: Many regulatory bodies worldwide recognize and endorse GS1 standards. Compliance with these standards helps healthcare organizations adhere to regulatory requirements, making it easier to meet quality and safety standards.
• Data Accuracy and Interoperability: GS1 standards facilitate the accurate capture and sharing of data across diverse healthcare systems and platforms. This interoperability ensures that information about medical products is consistent and reliable throughout the supply chain.
• Efficient Electronic Health Records (EHR): Integration of GS1 standards with EHR systems enhances the accuracy of patient records, medication administration, and billing processes. This contributes to a more efficient and error-free healthcare system.

The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) represent significant regulatory frameworks aimed at ensuring the safety and effectiveness of medical devices and in vitro diagnostic products within the European Union.

EU Medical Device Regulation (MDR):

Enforced in May 2021, the MDR replaces the previous Medical Device Directives and introduces a more comprehensive and stringent regulatory approach. Key aspects of the MDR include:

• Scope and Classification: Expands the scope to include a wider range of products, including certain aesthetic devices, and introduces a risk-based classification system.
• Increased Scrutiny: Imposes stricter conformity assessment procedures, particularly for high-risk devices, involving a greater level of clinical evidence and post-market surveillance.
• Unique Device Identification (UDI): Mandates the assignment of a UDI to each medical device, enhancing traceability and facilitating product recalls when necessary.
• Post-Market Surveillance: Requires manufacturers to establish robust post-market surveillance systems to monitor and report on the performance and safety of devices throughout their lifecycle.

In Vitro Diagnostic Regulation (IVDR):

Similarly, the IVDR, which became applicable in May 2022, addresses the unique challenges posed by in vitro diagnostic products. Key features include:

• Scope and Classification: Expands the scope to cover a broader range of products and introduces a risk-based classification system, aligning with technological advancements.
• Stricter Requirements: Imposes more stringent requirements on performance evaluation, including a greater emphasis on clinical evidence, to ensure the reliability and accuracy of diagnostic tests.
• UDI Implementation: Like the MDR, the IVDR introduces a UDI system for in vitro diagnostic products to enhance traceability and facilitate post-market surveillance.
• Transparency and Information Sharing: Enhances transparency by establishing a European database on medical devices (EUDAMED) to provide public access to information on medical devices and in vitro diagnostic products.

The Unique Device Identifier (UDI) system is a key component of the medical device industry, providing a standardized method for identifying and tracking medical devices throughout their lifecycle. The UDI system assigns a unique code to each device, allowing for improved traceability, safety, and patient care.

Purpose of UDI:

• Enhance patient safety by facilitating accurate and efficient identification of medical devices.
• Improve post-market surveillance and adverse event reporting.
• Enable better inventory management and supply chain visibility.

Importance of UDI:

• Regulatory Compliance: UDI is a regulatory requirement in many countries, including the United States and the European Union.
• Patient Safety: UDI enables healthcare professionals to quickly identify and track medical devices, reducing the risk of errors and adverse events.
• Supply Chain Efficiency: UDI improves inventory management, reduces waste, and enhances supply chain visibility.

The translation of Unique Device Identifiers (UDIs) to GS1 standards is a crucial aspect of standardization and harmonizing product identification in the global healthcare supply chain. UDIs, mandated by regulatory bodies such as the U.S. FDA and the European Union, are unique codes assigned to medical devices to enhance traceability and facilitate accurate product information management.

GS1 standards provide a globally accepted framework for the implementation of unique identification across various industries, including healthcare. When translating UDIs to GS1 standards, several key points come into play:

• Standardized Structure: GS1 standards ensure a standardized structure for identifiers, such as Global Trade Item Numbers (GTINs) and Serial Shipping Container Codes (SSCCs). This consistency allows for interoperability and seamless integration within the supply chain.
• Global Recognition: GS1 standards are recognized globally, facilitating communication and data exchange between different stakeholders in the healthcare ecosystem. This global recognition is essential for the efficient movement of medical devices across international borders.
• Data Synchronisation: GS1 standards enable accurate and synchronized data management by providing a common language for encoding information. This synchronization is critical for maintaining consistent and up-to-date product information across the supply chain.
• Enhanced Traceability: The translation of UDIs to GS1 standards enhances traceability by aligning with a widely accepted system. This alignment ensures that each medical device can be identified and tracked throughout its lifecycle, from manufacturing to distribution and beyond.
• Interoperability: GS1 standards promote interoperability by establishing a standardized approach to data exchange. This facilitates the seamless integration of UDI-related information into various systems, such as electronic health records and supply chain management platforms.

GTIN – An Overview

The Global Trade Item Number (GTIN) is a unique identifier used in barcodes and electronic data interchange to distinguish products and items in the global supply chain. Developed and maintained by the international standards organization GS1, GTINs play a crucial role in facilitating accurate and efficient inventory management, logistics, and retail processes.

GTIN – Registration:

• Membership registration on GS1 India website. (https://www.gs1india.org)
• Log in to your account and navigate to the GTIN creation section.
• Select the type of packaging (primary, secondary, or tertiary) for which you want to create a GTIN.
• Select the type of GTIN you want to create (e.g., GTIN-12, GTIN-13, GTIN-14).
• Enter the required product information, such as the product name, description, and packaging details.
• Assign a unique GTIN to your product.
• Validate the GTIN and ensure it meets the GS1 standards.
• Save and submit the GTIN for approval.
• Pay the applicable fees for GTIN registration.
• Once approved, you will receive the assigned GTIN for your product.

The Global Trade Item Number (GTIN) is a unique identifier used in barcodes to distinguish products in the global supply chain. The GTIN structure varies depending on the packaging level. Here’s a brief overview of GTIN structures for GTIN-8, GTIN-12, GTIN-13, and GTIN-14:

GTIN-8 (EAN-8):

• Length: 8 digits
• Usage: Commonly used for small-sized products or where space for a longer barcode is limited.
• Example: 01234567

GTIN-12 (UPC):

• Length: 12 digits
• Usage: Predominantly used in North America for retail products.
• Structure: Comprises a 6-digit manufacturer number, a 5-digit product code, and a check digit.
• Example: 123456789012

GTIN-13 (EAN-13):

• Length: 13 digits
• Usage: Widely adopted internationally for retail products.
• Structure: Consists of a 7-digit manufacturer number, a 5-digit product code, and a check digit.
• Example: 1234567890123

GTIN-14 (ITF-14):

• Length: 14 digits
• Usage: Used for cartons, cases, or pallets in logistics and retail.
• Structure: Comprises a 1-digit packaging level indicator, a 6- to 9-digit company prefix, a variable-length item.
• reference, and a check digit.
• Example: 01234567890123

Each GTIN structure serves a specific purpose in the supply chain, allowing for standardized and unique identification at different packaging levels. The variations in length and composition accommodate the diverse needs of products across industries and regions.

Global Trade Item Numbers (GTINs) play a critical role in product identification within the supply chain, and allocation rules help standardize the assignment of GTINs across various scenarios. Here’s a brief overview of GTIN Allocation Rules covering specific scenarios:

Different Language:

GTINs remain consistent regardless of language changes. Language-specific information is managed separately.

Additional Language on the Packaging Sold in Several Markets :

The GTIN will not change in cases where a language cluster already exists or is expanded.

Modifications to the package or minor changes to the artwork:

It is not necessary to assign separate GTINs for small adjustments to the artwork or the packing materials.

Assignment of GTINs within a Trade Item Hierarchy:

GTINs are assigned based on the packaging hierarchy, ensuring unique identification at each level (item, case, pallet).

Single-Use Non-Sterile Devices:

Each single-use non-sterile device is assigned a unique GTIN for traceability and inventory management.

Multi-Use Non-Sterile Devices:

GTINs are assigned to multi-use non-sterile devices, enabling accurate tracking and differentiation from single-use counterparts.

Declared Formulation or Functionality:

GTINs are assigned based on declared formulation or functionality, ensuring accurate representation and differentiation.

Barrier Packs – SITO Process:

Barrier packs undergo the SITO (Single Item Trade Unit) process, receiving a unique GTIN for individual identification within the pack.

Patient Specific Product:

Products designed for specific patients are assigned unique GTINs, facilitating personalized tracking.

Configurable Medical Devices:

Each configuration of a medical device is assigned a distinct GTIN, enabling precise identification and inventory management.

Software as a Medical Device:

Software designated as a medical device is assigned a GTIN, allowing for standardized identification within the healthcare system.

Declared Net Content:

GTINs are assigned based on declared net content, ensuring consistency and accuracy in product identification.

Dimensional or Gross Weight Change:

Changes in dimensions or gross weight may result in GTIN reassignment to reflect the modified product and also change over 20% to physical dimension, any axis (e.g., height, width, depth), or gross weight, requires of new GTIN

Add or Remove a Certification Mark:

Alterations to certification marks may prompt GTIN reassignment to maintain accurate identification.(e.g., European Certification Mark CE), that has significance to regulatory bodies, trading partners or to the end consumer, requires assignment of a new GTIN.

Primary Brand:

GTINs are associated with the primary brand, ensuring brand-specific identification. New GTIN is required whenever the trade item’s primary brand changes. “Healthcare Products Company” was the company’s previous main brand name; it is now “Leading Edge Healthcare Medical Products.”

Time Critical or Promotional Product:

Special handling, time-sensitive, or promotional products may receive unique GTINs to distinguish them from regular items.

Pack/Case Quantity:

GTINs are assigned based on pack or case quantities, aiding in efficient logistics and inventory management.

Example:A case configuration changes from containing 8 trade items to containing 12 trade items, the case needs to be uniquely identified. A pallet configuration changes from containing 12 cases to containing 16 cases, the pallet needs to be uniquely identified.

Pre-defined Assortment:

Products sold as pre-defined assortments are assigned specific GTINs for uniform tracking and traceability.

Minor Change to a kit by Brand Owner

If a Brand Owner changes an item within a kit and the item doesn’t have a GTIN, the Brand Owner doesn’t have to change the GTIN of the kit.

Price on Pack:

GTINs may include price information on the pack, aiding in pricing accuracy and point-of-sale transactions.

GS1 standards play a pivotal role in standardizing device packaging across the global supply chain, encompassing primary, secondary, and tertiary packaging levels. These standards ensure efficient identification, traceability, and communication among trading partners. Here’s a brief overview:

Primary Packaging:

• Definition:Primary packaging refers to the immediate packaging of a product, directly in contact with the device.
• GS1 Identification:Each individual device within the primary packaging is assigned a unique Global Trade Item Number (GTIN). Barcodes, such as DataMatrix or QR codes, are commonly used for encoding GTINs.

Secondary Packaging:

• Definition:Secondary packaging involves grouping primary packages for further protection, handling, and distribution.
• GS1 Identification:A unique GTIN is assigned to the secondary packaging, facilitating efficient tracking and traceability of the grouped devices. GS1-128 barcodes are often used to encode information such as GTIN, batch/lot numbers, and expiration dates.

Tertiary Packaging:

• Definition:Tertiary packaging comprises the outermost level of packaging used for bulk shipping and handling.
• GS1 Identification:Tertiary packaging is identified by a unique Serial Shipping Container Code (SSCC), allowing for the efficient tracking of large shipments. GS1-128 barcodes are commonly employed to encode the SSCC along with relevant logistics information.

Conclusion:

The GS1 standards for the healthcare sector, especially the medical device business, results in significant improvements in traceability and efficiency. Utilizing the Unique Device Identifier (UDI) system and Global Trade Item Numbers (GTINs), GS1 standards improve patient safety, expedite supply chain procedures, guarantee regulatory compliance, and promote interoperability throughout the healthcare ecosystem. The internationally acknowledged structure reduces the possibility of fake goods, enhances inventory control, and conforms to new laws like the EU EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). In overall, GS1 standards provide a critical basis for a future in medical device identification and healthcare management that is standard, networked, and secure.

References:

https://www.gs1.org/standards

https://www.gs1.org/standards/barcodes-epcrfid-id-keys/gs1-general-specifications