All UK medical-device manufacturers wishing to trade with the USA must ensure that their products carry a bar-coded Unique Device Identifier (UDI) to allow tracking through the entire supply chain.
To meet this need, Luton-based Trumpf Ltd (
www.uk.trumpf.com) has developed a laser and software module for UDI marking that creates corrosion-resistant marks on reflective materials using ultra-short-pulsed lasers.
UDIs — often applied in the form of a linear bar code or 2-D data-matrix code — combine static and dynamic identifiers.
The static portion is a unique dedicated code for the specific medical device, while the dynamic portion changes for each batch of products. There are currently three accredited UDI labelling standards: GS1, HIBC and ISBT 28.
Based on Trumpf’s TruTops Mark marking software, the new turn-key laser system creates compliant UDIs from company and production data in any of the three identification systems chosen by the user.
The whole process also functions in reverse, with the optional VisionLine Mark image-processing module enabling the Trumpf software to quickly scan and read UDIs on medical devices.
As part of the system, Trumpf can provide the right laser for any type of material, from stainless steel and aluminium to plastics and organic materials.
However, for medical-device applications, the company recommends its TruMicro Mark 2000, which offers 0.4 to 20pico-second laser pulses and pulse energies of up to 20µJ.
The corrosion-resistant marks maintain their high-contrast appearance, even after repeated cleaning and sterilisation, says Trumpf.
The pulses emitted by the TruMicro Mark 2000 are short enough to accommodate cold material processing.
This means that the time taken to absorb the laser energy is shorter than the time required to heat up the surrounding material, so the marking of the material is completed before thermal processes can take effect.
A big advantage of this method is that it allows the protective chromium oxide layer of the steel to re-form after processing, preventing the onset of corrosion.