Safety is a priority in medical technology: every process step must meet the highest requirements – from patient safety to compliance with standards and regulations. As product marking plays a key role in secure, seamless traceability and UDI compliance, it is crucial that manufacturers of laser marking devices also have a sound understanding of the processes, standards and industry-specific challenges.
The manufacturers of marking devices make a decisive contribution to the safety of medical devices and are becoming partners for medical device manufacturers when it comes to the safe implementation of marking requirements. When pioneering technology meets expertise, laser marking becomes a real game changer for greater safety and efficiency in the production process.
But what is important when we talk about “safe marking”? And how can maximum safety be integrated into the laser marking of medical devices right from the start? What aspects need to be taken into account for markings? How can marking be designed reliably and in compliance with regulations?
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Uncompromisingly corrosion-free: Can a laser marking withstand 1000 reprocessing cycles?
Corrosion resistance is a key safety criterion for the marking of medical devices. This applies to medical devices made of metal, such as surgical instruments made of stainless steel or implants made of titanium. If the products are used several times, the marking must withstand the reprocessing cycles without corrosion and without impairing legibility.
The Tuttlingen-based medical technology service provider Add’n Solutions and Foba Laser Marking + Engraving, manufacturer of laser marking devices for medical technology, conducted long-term tests in which the corrosion resistance and quality of laser markings were put through their paces: Laser-marked instruments were cleaned and passivated 1000 times in the fully automated system, then autoclaved and also subjected to periodic high-alkaline cleaning. This proved that the markings made with the Foba F.0100-ir ultrashort pulse laser are durable and reliable even after more than 1000 cleaning and sterilization cycles: “The marking is still perfectly legible. It survives the entire service life of an instrument. In the test instruments, the material gave up before the marking,” assures Dominik Pfeiffer from Add’n Solutions.
The so-called “black marking” effect is ideal for particularly high demands on marking quality, legibility and material integrity. The use of ultrashort laser pulses creates a nanostructure that appears like a deep black marking. Ultra-short pulse lasers such as the F.0100-ir from Foba are used for black marking. With this laser, pulse lengths in the femtosecond and picosecond range hit the material with high pulse energy. The infinitely adjustable pulse width enables maximum precision and optimum adaptation of the parameters to the marking requirements. The energy input is so focused and minimally short that the exact structures, known as “black marking”, are created with virtually no heat input and the integrity of the surface is maintained. This protects the material as much as possible and at the same time creates a marking that is safe in every respect: permanent, reliably legible from any angle, corrosion-free, biocompatible and biostable as well as UDI-compliant.
Highly developed laser technology offers all the prerequisites for the safe marking of medical products. With the highest accuracy and maximum material integrity with optimum legibility, it makes a decisive contribution to product safety and regulatory compliance.
What remains is safety: direct marking of sensitive medical devices
Thanks to constant innovation, laser marking is becoming increasingly popular for products and materials for which other marking methods had to be used in the past. This includes very sensitive materials, which include many medical plastics, as well as sensitive products such as pacemakers or other active implants. Traditionally, ink-based processes are used for such products, for example pad printing. However, inks or dyes are increasingly viewed critically in sensitive areas such as medical technology with regard to reliable legibility and biocompatibility. Added to this is the high proportion of rejects due to faulty printing results, for example due to smudging or discoloration. Complex quality controls and drying processes stand in the way of an efficient, smooth production process.
In contrast, laser marking is a highly efficient non-contact process. Without the use of potentially critical foreign substances, marking lasers achieve reliably legible, permanent, abrasion-resistant markings even on heat-sensitive products. In addition to the ultrashort pulse lasers mentioned above, highly developed UV lasers also enable extremely gentle marking. They are predestined for the high-contrast marking of sensitive medical plastics. As the marking is created by a photochemical effect and does not require any significant thermal stress, it is also known as “cold marking”. The material surface remains smooth and hygienic, while the marking is reliably legible and abrasion-resistant. “The latest technological advances in the field of UV laser technology enable reliable marking of materials that were previously difficult to mark with lasers: The wide range of applications and versatility of our V series with wavelengths of 355 nm (UV laser) and 532 nm (green laser) impresses our customers and continues to inspire our laser experts in the application laboratories. This benefits companies in the medical technology sector in particular, which often rely on direct laser marking due to strict regulatory marking requirements. We can offer them a reliable, secure marking solution for the most challenging materials,” promises Philipp Febel, Director Product Management, Marketing & R&D at Foba Laser Marking + Engraving.
From installation to quality inspection – process reliability with a system
However, the best marking alone is not enough to ensure maximum safety in medical technology. The marking process itself and its qualification are also decisive factors and central components of quality assurance. If the laser manufacturer provides support with qualification, medical device manufacturers benefit significantly. Knowledge of the optimum setup and adjustment of all parameters enables the entire validation process to be designed more efficiently, as Philipp Febel from Foba also explains: “Successful support for the IQ/OQ/PQ/MQ process is an integral part of our service for medical technology manufacturers. As laser experts, we contribute our specialist knowledge to our customers’ processes. This creates synergies that enable smooth, prompt installation and device qualification, which forms the basis for highly efficient, scrap-free, long-term stable production processes.”
Documented quality and stable manufacturing processes that enable reproducible marking results are key elements of validation and crucial for product safety and UDI compliance. HELP (Holistic Enhanced Laser Process), a camera-based marking process, is tailored to these regulatory and production requirements. The laser-integrated camera system IMP (Intelligent Marking Positioning) detects the position and geometry of the component before marking and automatically aligns the marking precisely to it. This ensures that the marking is applied exactly where it is intended – regardless of the position of the product to be marked in the marking field. This function is also important in light of the trend towards miniaturization in medical technology: especially when space is limited, such as on dental implants, minimally invasive instruments or catheters, high-precision positioning of the marking is crucial for reliable legibility. With automatic alignment and precisely adjusted parameters, micromarkings are achieved in optimum quality.
After marking, the marking result is checked “inline”, i.e. directly in the laser marking device, with regard to the content and quality of the code, and the results are documented. The efficient workflow reduces the manual inspection effort, minimizes rejects and enables complete documentation of the marking quality. A sophisticated camera-based marking process such as HELP therefore offers decisive added value in product marking: more safety, more efficiency, less risk.
From A for application tests to Z for the future: safe laser marking in medical technology
Laser marking is far more than just a marking process for medical technology. It is the basis for compliance, quality and traceability. Detailed consultation, application tests and the precise coordination of all parameters are essential for the optimal implementation of complex requirements. In the interplay of expert knowledge, technologically mature, validated processes, camera-supported precision and documented quality, laser technology makes a decisive contribution to product and patient safety. The efficient marking process is also future-proof: With extremely compact marking systems, intelligent interfaces and digital and automated process solutions, laser marking meets the requirements of modern production environments.
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