The FDA established the Unique Device Identification (UDI) system to enable easy, end-to-end identification, tracking, and regulatory compliance of medical devices. The process can seem complex to those new to UDI label compliance, but the basics are straightforward.
What Is UDI?
At its most basic, the UDI system is a globally accepted framework for tracking medical devices. In the UDI system, all medical devices are assigned unique identification numbers (UDIs). Similar to the vehicle identification number (VIN) used on cars, UDIs provide valuable information about a product’s manufacturer and production, as well as making it easy to track in the event of a recall or safety issue.
How to Understand UDI Labels
UDI labels can seem daunting at first, but they’re straightforward once you break them into their components.
Structure
UDIs are unique numeric or alphanumeric codes that generally consist of two parts: Device Identifier (DI) and Production Identifier (PI). The DI is a mandatory component of a UDI label—it identifies a device’s manufacturer and model or version. This number remains the same for every device of its type. The PI is a conditional section of a UDI Label. PI identifies variable information, which changes according to production controls, such as:
- Lot or batch number
- Serial number
- Manufacturing date
- Expiration date
Together, the DI and PI provide a comprehensive view of the entire lifecycle of a medical device.
Formats
Medical device manufacturers must provide a UDI in two formats: Human-Readable Interpretation (HRI) and Automatic Identification and Data Capture (AIDC).
As its name implies, Human-Readable Interpretation (HRI) is plain text that’s easily interpreted by healthcare regulators, providers, and patients. Automatic Identification and Data Capture (AIDC) allows access to digital information via scanning, typically a barcode or QR code.
Placement
The placement of UDI labels depends on several factors, most notably the level of packing, their class, and use.
For example, single-use medical devices such as syringes, catheters, and containers require UDI labeling on the individual item, or its packaging, as well as higher-level packaging. Conversely, reusable items like surgical instruments must have a permanent UDI. That is, one that lasts throughout the device’s lifecycle and can withstand repeated sterilization cycles.
Keys to UDI Label Compliance
The framework below provides a clear path to UDI label compliance.
Determine Device Classification
The FDA categorizes medical devices that require UDI labels into three classes based on their risk level to patients: Class I, Class II, and Class III.
- Class I: The lowest-risk category. These items pose minimal risk to patients and include common items like examination gloves, bandages, and thermometers.
- Class II: Medical devices that pose moderate risk fall into this category, including catheters, contact lenses, and infusion pumps.
- Class III: The highest-risk category. Implantable, life-sustaining, or life-supporting, these products carry the highest potential for illness or injury, and include pacemakers, heart valves, and cochlear implants.
As you would suspect, Class III devices must follow more stringent labeling requirements due to their higher risk.
Issuing Agencies
The FDA has accredited three organizations to issue UDIs: GS1, Health Industry Business Communications Council (HIBCC), and International Council for Commonality in Blood Banking Automation (ICCBBA). Each agency offers unique benefits and some are better suited to particular applications than others. Other considerations include integration with existing systems, maintaining consistent labeling standards across product lines, and compatibility with customer systems.
- GS1: A non-profit agency setting global standards for supply chains, healthcare, and more, including UPC and EAN barcodes. GS1 charges an initial fee as well as renewal fees at specific periods.
- HIBCC: A non-profit focused on setting healthcare standards assigns UDIs. This group charges a one-time fee.
- ICCBBA: A non-profit focusing on standards for medical products of human origin. It’s approved to issue codes for niche products, including blood bags, human cells, human tissues, and cell- and tissue-based products. This organization charges a registration fee and scaled recurring fees.
Device Packaging
The device and its packaging determine UDI label compliance. For example, rubber gloves might need a UDI at the carton, case, and package level, while the gloves themselves may only need a virtual UDI. In other words, there’s no physical label on the item itself; rather, it’s linked back to the base packaging. Conversely, reusable medical devices—like surgical tools—require a permanent label directly on the item.
Global Unique Device Identification Database (GUDID)
UDI label compliance requires manufacturers to submit device information to the Global Unique Device Identification Database (GUDID) and maintain their records through its lifecycle. Information stored in the database includes details about the manufacturer and device or model.
UDI Label Compliance as an Opportunity
It’s easy for medical device manufacturers to view UDI labels as another hurdle to cross before bringing a product to market. While the UDI system often focuses on the downstream benefits to healthcare providers and patients, it also presents an upstream opportunity.
The UDI label process also gives manufacturers a chance to scrutinize their workflows, identify inefficiencies, improve productivity, and reduce costs. The UDI system also enables fast and effective recalls and improved in-market monitoring.
Electronic Imaging Materials, Inc.
Ensuring UDI compliance can seem complex, but sourcing labels doesn’t have to be. For almost four decades, EIM has been providing professionals in industries—including medical devices and healthcare—with solutions to the most challenging label issues. Contact the Label Experts to learn how we can assist you with UDI label compliance or request samples and see for yourself.
