In cooperation with FOBA Laser Marking + Engraving, add’n solutions GmbH & Co. KG of Tuttlingen, Germany, a service provider for UDI laser marking on medical devices, conducted a long-term study on reusable surgical instruments to prove that laser marks remain readable despite multiple reprocessing procedures. The UDI must resist increased wear throughout the whole product life cycle to ensure the required safe traceability.

The comprehensively documented study demonstrates that laser marked, high- contrast codes can resist at least 500 sterilization and cleaning cycles. FOBA’s short-pulse fiber marking lasers have been optimally adapted to the surface characteristics of different types of stainless steel. Appropriate laser parameters prevent inscriptions from fading out or corroding. Additional passivation ensures that the entire device, including marked areas, is protected against corrosion. The American standard for the passivation of stainless steel, ASTM 967, was used for instrument passivation.

Add’n solutions used a precisely matched laser marking process, followed by a cleaning and passivation cycle. The surgical instruments were sterilized and cleaned 500 times, simulating actual wear conditions in a hospital. Steam sterilization was accompanied by instrument cleaning with high alkaline cleaners (pH value 14), equivalent to clinical cleaning procedures.

A direct mark on a medical product must be of high contrast and resistance, and it cannot have a negative impact on the surface quality. Until recently, it was unknown how often laser-marked surgical instruments can be reprocessed without negatively impacting mark quality.

FOBA Laser Marking + Engraving Solutions