UDI labeling plays a critical role in enhancing patient safety, improving traceability, and ensuring regulatory compliance throughout the medical device lifecycle. While the concept behind UDI labels is straightforward, their implementation presents several challenges.
To find the right UDI labeling solution for your medical device, you need to understand its demands and how to address them.
What Is a Medical Device UDI Label?
Unique device identification (UDI) is a labeling standard that facilitates the identification and tracking of medical devices throughout their lifecycle. UDI labels are required on a broad range of medical equipment and supplies, from innovative technologies like artificial organs and implantable cardioverter-defibrillators to everyday clinical items like cotton swabs and tongue depressors.
UDI labels are composed of two primary elements:
- Device Identifier (DI): verifies the manufacturer, model, packaging configuration (like how many tongue depressors are in a box), and attributes like single-use status and sterility
- Production Identifier (PI): communicates more variable qualities, like manufacturing date, expiration date, serial number, and lot number
Together, the DI and PI provide a comprehensive picture of a medical device and enable traceability from origin to end use.
The Challenges of Medical Device UDI Labels
UDI labels are ubiquitous on today’s medical devices. However, an assessment of barcode use in collaboration with a large, self-distributed hospital network by GS1 US—the nonprofit that manages the global GS1 system of standards in the United States—found their use still poses difficulties for many personnel.
Whether it’s being too busy, too confusing, or too poor quality, the fact is that scanning UDI barcodes comes with real objections and obstacles. One simple step toward increasing adoption and maximizing the effectiveness of UDI medical device labels is to ensure they work every time. To do this, manufacturers need to know the challenges their labels face and proactively seek solutions.
Data Density
Problem: UDI labels can contain a lot of information. Furthermore, compliant UDI labels must satisfy dual requirements: human readability and machine scannability via Automatic Identification and Data Capture (AIDC) technology. Getting all the required information onto a UDI label is notoriously difficult. This is particularly true of small and complex devices.
Solution: Seasoned converters, like EIM, can help medical device manufacturers solve the most challenging label issues. Using 2D barcodes or GS1 Application Identifiers (AI) are proven strategies for ensuring information critical to compliance is captured on a label.
Demanding Operating Environments
Problem: Medical devices are commonly exposed to demanding environments such as cryogenic storage and high-heat autoclave sterilization. Both can result in labels degrading and negatively impact legibility, scannability, and adhesion.
Solution: Selecting labels specifically designed for the application they’re being used in—and the challenges they’ll face—is essential for long-lasting, compliant UDI labels. For example, our CryoLabel® Cryogenic Labels can handle temperatures down to -320°F, withstand exposure to liquid nitrogen, and resist moisture through repeated freeze-thaw cycles.
Repeated Sterilization, Cleaning, and Handling
Problem: Devices ranging from surgical tools to lab equipment are often subject to frequent cleaning and sterilization, exposing them to harsh chemicals and solvents. They’re also handled repeatedly. All of this can lead to peeling, abrasion, and ultimately, non-compliant labels.
Solution: Work with a label supplier to identify materials, adhesives, and print methods built to perform—even when exposed to chemicals, cleaning, handling, and abrasion. Test and validate label performance before full-scale production to reduce the risk of label failure and future compliance issues.
Low-Surface-Energy Materials
Problem: Medical devices are made from a wide variety of materials and UDI labels must remain securely attached for their entire lifecycle. Some devices, like glass slides, vials, and metal tools, are generally easy for labels to adhere to. However, others, such as silicone tubing, polypropylene containers, and polyethylene bottles, have low-surface-energy surfaces, which are tough to stick to.
Solution: Sourcing labels with high-tack adhesives engineered for specific surfaces is key to mitigating risk across the device lifecycle, from production through end-of-life. Before committing to a label, it’s essential to test adhesion and ensure your label stays stuck.
Complex Shapes and Sizes
Problem: It’s common for medical devices requiring a UDI to have a tough-to-label shape or size. Whether it’s curved or cylindrical surfaces or a limited labeling area, the wrong label can cause issues ranging from adhesion issues to distorted and illegible barcodes.
Solution: Converters like EIM can custom-build labels specifically for odd-shaped and space-constrained devices. In the end, labels tailored for the unique attributes of a device lay flush, resist peeling, and remain readable.
Electronic Imaging Materials, Inc.
There are a lot of challenges facing UDI Medical Device Labels, but finding a label supplier doesn’t have to be one. If you’re wondering How do I choose a UDI label printer for medical devices? Look no further than EIM. Our Label Experts can help you identify the right combination of materials, adhesives, and printing methods, and send you samples so you can verify their performance for yourself.
