Let’s start with the basics.
UDI stands for “Unique Device Identification.” In other words, placing unique IDs onto medical equipment to improve tracking and traceability. In December 2013, the International Medical Device Regulators Forum (IMDRF) published guidance for the international adoption of UDI. Currently UDI is only mandatory within the USA but other countries are also pursuing compliance.
If you're in the medical manufacturing field or just curious about compliance, here are five things you need to know about UDI.
The majority of medical instruments are small and undergo repeated disinfectant or sterilization processes. In many cases, paper labels cannot be used for part tracking because they do not withstand the cleaning process and are not small enough to fit on the parts. Furthermore, labels may peel off when the equipment is used and become embedded in patients, ultimately causing harm and negating the benefits of added tracking and traceability. These issues highlight the reasons why direct part marking is a benefit to medical device manufacturers and patients alike.
Managing medical equipment through direct marking offers the following advantages:
• Quality control by monitoring how frequently tools are used
• Optimized part replacement and ordering
• Improved efficiency and standardization of instrument sets
• In-process instrument tracking (location management)
• Excess stock control
• Loss and theft analysis
The following GS1 codes are industry standards for medical instruments.
• GS1 DataMatrix (When the area for GS1-128 cannot be secured)
The following label item information must be assigned to the GS1 code.
• 01: GTIN (Product Code) / 10: Lot Number / 17: Expiry Date
• 21: Serial Number / 11: Manufacture Date
The 2-digit number called the AI (Application Identifier) is contained within parentheses when displayed as human-readable. The display size of direct marking on healthcare products - specified by GS1 standards - is as follows.
GS1 Date Matrix Specifications
Paper labels and inkjet printers fail to meet permanent marking requirements mandated by UDI. So what should you use?
Depending on your part and application, lasers markers are an ideal solution. These systems offer superior marking flexibility, including:
Black marking - Heats the surface of a part to create a black mark
Engraved marking - Removes the top surface of the part by etching away material
Cold marking - Colors the surface black while leaving an oxide film intact
Black marking method
Engraved marking method
Cold marking method
Many medical components have a chromium exterior. Chromium turns into chromium carbide through heat (reducing its corrosion-resistance). Conventional near-infrared lasers use heat to create black contrast, which risks causing corrosion over time. UV lasers - thanks to photolytic processing - can mark parts without damaging the surface material. Check out our wavelength guide to learn more.
Salt water corrosion test: near-infrared (left) vs. ultraviolet (right)
KEYENCE has been an innovative leader in the laser marking industry since the early 1990’s. Our high speed, precision processing capabilities have evolved to include the world's first 3-Axis lasers and unrivaled marking quality among UV, Fiber and CO2 systems. The newest laser markers from KEYENCE are built upon years of experience and hands-on application knowledge. KEYENCE is committed to introducing new cutting-edge products that go beyond the expectations of its customers.
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