FEATURE Medical
Laser marking eases the route to UDI & MDR track & trace compliance
By Andy Toms, Director, TLM Laser W
hen fully implemented, unique device identifi cation (UDI) will provide a consistent
standard for device identifi cation and coding, for unambiguous and robust identifi cation of a specifi c device. The FDA, EU and other regulators have all developed UDI systems in line with International Medical Device Regulators Forum (IMDRF) guidance. The adoption of UDI facilitates easy and reliable traceability of medical devices, whilst at the same time enhancing the eff ectiveness of safety-related activities for devices, by enabling enhanced monitoring of their status and use at all levels. Additional anticipated benefi ts from these regulations will include helping to reduce medical errors and aid in the fi ght against counterfeit items.
The best solution Understanding the requirements for UDI, whilst essential, is just the start of the process. Generating both human as well as machine-readable alpha-numeric text and codes for each device requires technology that is capable of producing clear, consistent and indelible marks. Also, in the case of items such as surgical instruments, these marks must withstand the rigours of use over time.
Lasers provides a clear and durable mark – essential for UDI and MDR compliance. FOBA’s IMP system ensures the correct mark is produced on the right component and in the correct place
FOBA’s fully-integrated vision and laser solution, available from TLM Laser, is the ideal solution for UDI marking
Laser technology has repeatedly proven to be the optimal solution for marking the diff erent metals and plastics used within the medical device sector. However, prior to creating the mark on any medical device or product, it is essential that the mark will be placed on the correct component and in the correct location.
Unique and innovative FOBA’s unique and innovative closed- loop machine vision and laser solution, available in the UK and Ireland from TLM Laser, provides an integrated solution within the laser system itself. The patented vision system IMP (intelligent mark positioning) ensures consistent and correct marking with pre- and post-mark optical validation as part of a three- stage closed-loop marking process. This vision-supported laser system helps manufacturers build a more robust and cost-eff ective UDI marking process. Prior to marking, the system performs a part-validation check to ensure that the part to be marked is the correct variant, followed by a part-verifi cation
36 December/January 2022 | Automation
check to ensure that the part has not been previously marked. The automatic mark-alignment function is used to check the position of the mark relative to the position of the component about to be marked. Only once these checks are completed satisfactorily is the laser mark produced.
The post marking verifi cation stage validates that the laser marks are where they are expected, checking for positioning, alignment and size. Optical character verifi cation (OCV) then validates that every character marked by the laser matches the content expected. The contents of 1D and 2D data matrix codes are also read and compared to the content expected. This unique three-stage marking process, combined with the patented vision system IMP, ensures the highest levels of process reliability and most importantly, zero defect marks.
CONTACT:
TLM Laser
www.tlm-laser.com
automationmagazine.co.uk
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