20 January 2017

TLM Comments on HELP for Navigating UDI Challenges

In the last quarter of 2016 the latest stage of the FDA’s UDI system came into force. This latest set of regulations covers the permanent marking of multi-use Class II devices, the labels and packages of Class I products and devices not previously classified and Class I stand-alone software.

There are a number of challenges around UDI. Manufacturers face the challenge of finding a physical space, on small implants such as plates or screws, to place the 2D code and the human readable content. 2D codes, such as a data matrix, need a certain physical space to enable them to be readable. On the other hand a UDI starts with a minimum of 14 characters. Based on current readability requirements, a UDI 2D code would have to be at a minimum 5mm by 5mm. It is clear that this in itself may be a challenge on some devices or implants.

Having achieved the requirement to produce the UDI code, it is essential to be able to validate these tiny marks before the product is transferred to the next production stage or indeed released to market. This can be an enormous challenge, marking very small devices with the accuracy of a tenth of a millimeter or less. Validating these marks is as critical as their placement. There is however a well-established automation principal which is to perform as many operations as possible whilst having control of the part.

This concept has been embraced wholeheartedly by FOBA within their holistic vision-assisted laser marking process called HELP (Holistic Enhanced Laser Process). This combination of pre-mark verification, followed by laser marking and then post-mark verification in a closed loop is unique as it is among the only known fully integrated commercial products that delivers all the above in a simple fully integrated user interface.

Within the medical device manufacturing industry this solution delivers a clear advantage from its uniqueness and performance over existing technologies. Having all of the required processes in a closed loop not only ensures compliance with the latest UDI regulations, but generates cost savings by eliminating false marking which in turn can cause expensive parts to be scrapped.

FOBA’s HELP System Simplifies the Marking and Validation Process

Although the HELP concept was driven by the increasing regulatory demands of the medical sector, any manufacturer who is producing parts with a number of variants and a requirement to marking them and validate the content could benefit from the capabilities of HELP. As an example, safety critical aerospace or automotive parts would fall into this category. 

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