Boedeker Plastics, Inc. Adds UDI Laser Marking Technology for Medical Industry Clients
What is UDI?
UDI stands for unique device identification, which is a labeling system established and implemented by the FDA for various classes of medical devices through their distribution and use. Once fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form. The UDI System offers a wide range of benefits to industry, FDA, consumers, health care providers and health care systems. Some of these benefits include more accurate reporting, reduced medical errors, quick access to detailed information about the device, more efficient management of recalls, and many other benefits.
When is the Compliance Date for UDI Labeling for Class II Devices?
According to the FDA’s website September 24, 2018 was the UDI compliance date for the direct marking of all class II devices. On this date, UDI is required for most kits with at least one class III, I/LS/LS or class II device within the kit as well. Also, UDI is required for most co-packaged and cross-labeled combination products with a device constituent.
Boedeker adds UDI Laser Marking System
With the new UDI requirements, Boedeker Plastics, Inc. added UDI laser marking technology in 2018 for medical industry clients.
Boedeker Plastics, Inc. was the first company in North America to combine ISO Certified 13485 plastics only precision CNC machining with in-house UDI laser marking technology.
This added technology offers medical customers a single source solution for high quality parts that comply with the FDA’s new UDI labeling requirements.
“We carefully evaluated multiple UDI systems before selecting our system. The system we implemented incorporates a hybrid laser marking technology, cutting edge software, multiple inspection features and other state of the art technologies. We are excited to have in-house UDI laser marking capabilities for our medical customers and the added capability of UDI compliant laser marking,” said Process Engineer, Michael Kenning.
Our UDI Laser Marking system is comprised of a Worx housing and Keyence MD-X1020 Hybrid Laser Marker (see image to the left).
This system is equipped with a unique laser oscillation technology that combines the characteristics of both YVO4 and FIBER lasers to deliver a fine quality, high speed mark unlike any other laser system.
It has a built-in camera that can also be used to measure the focal distance and automatically adjust to eliminate marking defects caused by focus misalignment. The camera can also be used to read and verify 2D codes, which automatically marks the target (part) and then verifies the printed data for readability. In addition to pass/fail verification, the laser marker can judge the marking quality of the 2D code after it is marked and output this value giving it comprehensive traceability.
The UDI system has specialized marking software to generate 2D label codes that are programed from the customer’s label parameters. The image on the left shows a part after it has been laser marked using our UDI laser marking.
Below in Figures 1 & 2 are screen views from our marking software. The screen view is split showing the target (part) on the left and the label code on the right. The target (part) image is fed to the software from the systems camera that is focused on the target (part) during the marking process. The camera also inspects using pass/fail verification along with measuring the quality and records this value giving it comprehensive traceability.
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For detailed information on UDI, please reference the FDA’s web page on Unique Device Identification – UDI