Laser marking on medical devices and components is necessary to ensure product quality, prevent counterfeiting and increase patient safety.
A UDI code is mandatory for manufacturers in almost all countries worldwide. For this reason, Laser marking has taken on a key role in the process of manufacturing medical devices and components of all safety classes.
Safer than any other technology
The UDI (Unique Alphanumeric Identification) code is applied to medical devices to ensure product Traceability, benefiting both manufacturers and the patients themselves. The code is mandatory and serves to guarantee:
Laser marking is the most widely used technology in medical industries, as it ensures the highest standards of safety and durability.
Direct marking in the medical industry follows a precise code system – GS1-128 and GS1 Datamatrix – containing mandatory information for traceability purposes.
Our laser marker uses the following processes to apply these codes:
DI (Device Identifier)
The UDI code must be visible to the human eye and applied to all devices, which can be divided into the following categories:
Laser marking resists corrosion and chemical agents. The result is permanently visible and does not fade. Laser marking is the most reliable tool for operating room devices, as the size numbers (on scalpels for example) are useful to surgeons during operations. Laser marking thus plays a fundamental role.
Annealing is the most common laser marker process used on medical devices and components. Annealing gives an impalpable surface laser marking. The surface is completely smooth to the touch. Unlike other marking and engraving processes, no material is removed. The surface is therefore unaltered and the marking defined.
Detergents, disinfectants, sterilization and passivation processes can corrode the UDI codes on stainless steel medical devices and components. A preventive study of these factors can avoid this situation, as can setting ideal marking parameters to ensure long-lasting results and unchanged contrast.
For plastics, usually test-tubes or very thin tubes, LASIT has replaced the UV technology with laser technology that marks all medical devices and components while maintaining high-quality standards.
Fly UV colors the surface of the product with a photochemical process and the heat produced by the marking is so limited that it does not damage the medical device or component.
With a typical pulse duration of 20 ns and a beam diameter of 10 µm, the FlyUV processes surfaces without damaging them, unlike normal infrared marking on plastics. This laser is ideal for the medical sector (catheters and insulin pumps can be given a durable marking, resistant to sterilization), and for glass components which can be watermarked.
In the LASIT Laser Test laboratory, we carry out resistance tests of the laser marking to citric passivation processes, with a subsequent verification of material oxidation through a 24-hour salt spray cycle. In this way, we can guarantee that the specific laser we use to carry out the tests maintains the quality and functionality of our customers’ products unaltered.
Picosecond laser, a unique fiber laser technology, has gained renown in the medical industry for its unrivalled results on metal components. The main advantage is the total absence of reflection on the laser marking, no matter what the angle of light. Moreover, the Picosecond laser is three times faster than the traditional fiber laser in terms of production.
The ultra-short pulse duration allows the Picosecond laser to mark materials where traditional nanosecond infrared lasers can’t. Its almost cold ablation also makes it suitable for a wide range of materials and applications, virtually eliminating heat transmission on components.
Implants are extremely delicate. This factor, together with the demand for multi-sided marking, made it necessary to create a laser marker with an anthropomorphic robot to take the parts from the template and position them under the laser head at all the required angles.
The exact centering and positioning of each component by the robot under the laser offers not only an aesthetic value for the marking of alphanumeric codes, but also a functional value: alignment notches, which are essential for correct insertion of the prostheses in the operating room, were also marked on the implant.
Since the same machine marks all three components, the laser marking machine is equipped with a multi-magazine and a fully automatic pick-up and positioning system.
Once the pallets have been loaded into the magazine, the laser marker works without the need for an operator: the software identifies the type of component through a specific Datamatrix code, sets the corresponding marking, and starts the cycle.