Unique Device Identification (UDI) labels play a critical role in worldwide healthcare. They provide the framework necessary to track medical devices throughout their lifecycle—from manufacturing through distribution and use—ensuring patient safety and facilitating regulatory oversight.
UDI systems only work as well as their labels. That means barcode labels that remain readable, scannable, and firmly attached for the entire life of the device they’re on.
What Is UDI Labeling?
At its most basic, UDI is a standardized labeling and tracking system for medical devices. It covers everything from single-use disposable items like medical gloves, cotton swabs, and depressors to life-sustaining devices such as pacemakers and cutting-edge technology like robotic surgical systems.
For single-use devices such as tongue depressors or bandages, the UDI may be printed on the packaging or bulk box instead of the device itself. Reusable items, such as surgical tools, require a durable UDI label able to withstand repeated use and sterilization throughout their service life.
HRI and AutoID
The UDI system assigns a unique code to each device, similar to the VIN on a car or the code on your passport. It identifies the device and allows tracking through its lifecycle. UDI labels are required to present information in both human-readable interpretation (HRI) and automatic identification and data capture (AutoID) formats.
- HRI is simply a format that healthcare personnel can read without using technology. It provides a backup in the event a barcode fails and allows verification of critical data.
- AutoID technology enables scanners and automated systems to capture and process data quickly, accurately, and with minimal human intervention. The information is typically encoded in 1D and 2D barcodes.
What Are the Core Components of a UDI Label?
What are the key requirements for unique device identification (UDI) labeling in medical devices? UDI labels consist of two parts: a Device Identifier (DI) and a Product Identifier (PI).
- Device Identifier (DI) specifies the manufacturer, device name, packaging configuration (e.g., single-unit or box of 10), and attributes such as sterility and single-use status.
- Production Identifier (PI) includes information about production, such as lot or batch numbers, serial numbers, expiration dates, and manufacturing dates.
The DI portion of a UDI label is static, as attributes like manufacturer and device name remain the same. Conversely, the PI is dynamic and can change with every production run or item.
5 Benefits of UDI Labels
The Unique Device Identification (UDI) System, and more specifically UDI labels, offer a range of benefits to the regulators, consumers, and the healthcare industry as a whole.
Inventory Control
UDI labels provide a streamlined method for tracking devices, monitoring stock levels, optimizing replenishment, and facilitating automation. This results in better resource deployment, less waste, and more cost efficiency.
Data Management
The traceability and visibility provided by UDI labels generate a wealth of information about the use, performance, and safety of medical devices. Insights gained from this data can be used to optimize inventory, identify issues, assess cost-effectiveness, and support the development of new devices by monitoring the market and simplifying regulatory submissions.
Patient Safety
UDI labels provide healthcare professionals with critical information about a device’s specific characteristics. This ensures patients are paired with the proper device and minimizes the potential for errors. UDI labels enable rapid tracking and identification, which in turn facilitates efficient and timely recalls of medical devices—further enhancing patient safety.
Another advantage of UDIs is that they make it difficult for counterfeit devices to enter the market, protecting patients from unsafe products and preserving trust in the medical supply chain.
Improved Outcomes
The ability to track medical devices throughout their lifecycle allows healthcare professionals to monitor performance, detect problems, identify trends, and investigate concerns—all of which equates to better patient outcomes.
Compliance Assurance
UDI labels are more than beneficial—they’re required for most medical devices. The FDA mandates UDI labeling for products marketed and sold in the US. The cost of non-compliance is considerable, as it can lock out markets and inflict reputational damage.
Selecting a UDI Label
The fact is, not every label can meet the demands of medical device labeling. UDI labels face many challenges. They must stay readable, scannable, and firmly attached, often while resisting extreme temperatures, hot/cold cycles, chemicals, and abrasion. Some factors to consider when choosing a UDI label include:
- Topcoats for extra protection against chemicals and abrasion
- Printing methods that produce high-quality, durable, and long-lasting images
- Facestocks that can withstand extreme temperatures, such as cryogenic storage and autoclave sterilization
- Adhesives that remain securely attached to even the most challenging materials and in harsh environments
Performance is an absolute must for UDI labels. When a UDI label fails, it poses real risk to everything from patient safety to manufacturer compliance to data integrity. Consequently, choosing the best labels or best label partner is indispensable.
Electronic Imaging Materials, Inc.
If you need help labeling medical devices and meeting UDI requirements, the Label Experts at EIM are the perfect partner—from product to patient. With roughly 40 years of labeling experience, we deliver a healthy dose of expertise and reputation for building relationships that stick with our customers. Contact the Label Experts today to learn about our label solutions. Or request samples and see for yourself.
