The EU’s Medical Device Regulation (MDR) and US’ Code of Federal Regulations Title 21, about the labelling of medical devices (21 CFR 801 Subpart B), require a Unique Device Identification system (UDI) on each medical device, in addition to the creation of a central UDI database.
Several key public health targets are meant to be covered through UDI, such as anti-counterfeiting, safety communication promotion, reduction of inappropriate use of the device as well as the management of adverse events, incident reporting and efficient device recalls.
Laser marking is a valid alternative to get the unique identifier permanently attached to the medical device and offers a series of additional advantages compared to alternative technologies like labelling, pad printing, or hot stamping. Digital information can be created and stored in a digital database, facilitating traceability tasks and regulatory requirements, while digital data manipulation enables high flexibility to fit laser marking according to the required size of the device, the available surface, and geometry. Adhesives or glues used in labelling or dyes /solvents needed in conventional printing processes are not required, avoiding contamination issues and the environmental impact related to the use of such substances.
Some materials can be more readily laser-marked than others, while some will give very poor results; indeed, that`s because it is very important to select the correct material to be laser-marked, besides choosing the correct laser-marking machine settings. In addition to the material, special attention should be given to its colour, in particular to the formulation of the colour that gets combined with the material and it’s needed when creating certain laser marking effects or contrasting colours.
In the case of reusable medical devices, frequent cleaning, disinfection, or sterilisation procedures need to be also carried out to allow their safe reuse. The long-term readability of HRI (Human Readable Interpretation of the data characters) and AIDC (Automatic Identification and Data Capture through bar codes, smart cards, biometrics, and RFID) falling within the expected device lifetime is a challenging task. For this reason, it becomes even more important to maximise the contrast and resolution of the laser-marked text and make it indelible. Therefore, specific medical materials optimised for laser marking have been developed.
Considering that ABS polymers are widely used in the production of external enclosures, covers, or shells for reusable medical devices to achieve a high level of aesthetic, functionality, and medical regulatory compliance, it’s important to bear in mind that ABS is in itself a laser[1]markable material. Correct laser settings allow good laser-marking results to be achieved, nevertheless, there are special ABS formulations that have been optimised for laser-marking and can be used for boosting the contrast and resolution and attaining the desired colour and contrasting effect on the surface of a medical device.
Special ABS formulations are particularly valuable when other relevant properties of the material come into play and must be maintained alongside the laser marking optimisation, like for example the biocompatibility requirement according to ISO 10993.
