Healthcare Unique Device Identification (UDI) Labeling

Posted March 27, 2012

Industry Need

The FDA’s developing UDI (Unique Device Identification) standard highlights the capacity of auto-ID technologies to enable significant improvements in patient safety. Quick, effective recalls and adverse event reporting are difficult with current medical device management systems, and UDI is targeted to drive major enhancements. Pushing traceability to the device level enables manufacturers and users to quickly identify, locate, and pull recalled units from service; connecting adverse events to a unit serial number can reveal failure trends previously missed with manual checks.

The FDA is developing the unique attributes with input from the GHTF (Global Harmonization Task Force) for Automatic Data Collection of the device’s lot and serial number to maintain a chain of custody record for the life cycle of the Medical Device.

Additional benefits to full implementation include accurate device usage data yielding improved maintenance effectiveness. Direct input of device usage into electronic health records can provide significantly increased accuracy of patient service history and billing. Selecting the correct printers and media help ensure UDI labeling delivers the intended benefits in challenging healthcare environments.

Reference Links

FDA Unique Device Identification overview

Intermec Solution

With periodic exposure to fluids, frequent handling, and regular disinfection, healthcare settings can quickly degrade common label materials. Intermec Duratran II polyester labels, paired with TMX3000 series resin ribbons, provide the durability required to ensure survival for the life of the medical device. High tack adhesive provides a strong bond with typical metal, plastic, and painted surfaces; high performance adhesive satisfies labeling requirements on textured surfaces. With off-the-shelf UL recognition, these products are ready for streamlined implementation in device manufacturing processes.

Premium print quality provides easily scanned 1D and 2D symbols, enabling smooth implementation with existing IT systems. Printing on demand with Intermec thermal printers such as the PM4i, this durable labeling system provides the flexibility to satisfy the Unique Device Identification for Medical Devices through distribution and field use.

Media Recommendation

Duratran II 2 mil polyester with high tack adhesive
Duratran II 2 mil polyester with high performance adhesive

Ribbon Recommendation

TMX3000 series resin ribbon

Printer Recommendation

PM4i Mid Range Printer

  • Smart – Powerful smart-printing capabilities enable error-proof labeling and can simplify processes; all-in-one printer language abilities for drop-in simplicity
  • Strong – Superior throughput, designed to excel in demanding environments
  • Secure – Industry leading, advanced and secure network connectivity options

PC43t Desktop Printer

  • Intuitive – Super Easy to Install & Use
    • 10-language LCD or Icon graphics user interface maximizes uptime
    • One hand media loading for trouble-free use
    • Fastest throughput in its class at 8 ips
    • Quick configuration with USB stick device
  • Flexible – Fits your business needs today & tomorrow
    • User installable connectivity upgrades and accessories for scalability
    • Leading command languages for seamless deployment
    • Modular IT-friendly design speeds up deployment and support
  • Smart – Keeps you informed & productive
    • Remote status updates with Intermec tools minimize downtime
    • Programmable with ability to directly add keyboard or scale improves efficiency

The Intermec Advantage

When patient safety hinges on reliable traceability, it is essential that UDI labeling system components work together flawlessly. Intermec printers and media are optimized to deliver superior performance when used together. Our rigorous testing and co-engineering ensures consistently high print quality, proven label and tag performance in demanding real-world environments, and maximum print head service life for reduced downtime.

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