Manufacturers of components for medical devices need to mark their products and packaging for a number of reasons; to identify the product, to add instructions for use, and to enable tracking and traceability. Now that the FDA UDI rule has become final, a more standardized approach to marking medical device products is required, making recalls more effective and ensuring patient safety.
If your medical device is something that could be used more than once, the new standard required direct part marking (DPM) on that device. Laser marking for identification of medical devices is commonly used because the mark is conspicuous, permanent, and will withstand repeated use and sterilization. A laser can “engrave” or mark the object at high-speeds and can allow variable data printing for serialization, making it a useful method for marking devices in a production line.
For many products that require direct part marking, the type of product identifier best suited for compliance with UDI is a GS1 or HIBCC data matrix barcode, a two-dimensional barcode capable of holding large amounts of data in a relatively small space. Laser marking has such capabilities so you can mark your products and include all the required data for compliance.
ID Technology provides both CO2 and YAG lasers for direct part marking of medical products. We will be happy to help you decide which is best for your application as well as working with you to design the compliant marks needed to meet the requirements of the standard.
How do you achieve direct part marking? Would laser marking be a better alternative? Talk to us and find out how laser marking can fit in your application. Give me a call at 603-598-1553 to talk labeling, DPM or UDI.
And speaking of UDI, we offer seminars throughout New England. Ensuring UDI Success! is a free event, where we review the mandate itself, GS1 & HIBCC barcode standards, RFID, labels and labeling, direct part marking, the Global UDI Database (GUDID) and other relevant topics.
Want to join us? Check out our Events page. If a seminar is not currently scheduled, please call David Holliday at 603-598-1553 x 237 or use our contact form for help with your UDI planning and implementation.