Traceability In The Medical Sector—Technical Challenge

Accuracy, efficiency and safety are the key words of an industry at the cutting edge of technology. Governed by numerous standards ensuring the reliability of its components, the medical sector has implemented numerous traceability processes over the last few years.

Thanks to the markings applied to the various components, it is possible to obtain information about the manufacturer, but also the component reference number or their expiry date. All this data complies with the UDI (Unique Device Identification) and MDR (Medical Device Regulation) standards, which are essential for exporting devices to the USA and Europe.

The components to be marked are as diverse as the professions that make up the medical sector. There are, for example, many cases of marking on surgical instruments such as scalpels or bistouries, but also on prosthetics or orthoses, made of steel, cobalt, ceramics or biomaterials, dental implants, often made of titanium, or hearing aids or pacemakers.

In order to ensure optimal identification throughout their distribution and use, these multiple devices must have a marking composed of different elements. In order to comply with the standards mentioned above, it must contain a machine-readable barcode or Datamatrix as well as several alphanumeric codes that can be identified by humans. Quite often a logo is applied, meeting a need that is more aesthetic than practical.

In addition, there are many constraints linked to the complexity of the marked components and the sector of activity. For example, the materials with which the various devices are made are complex and varied (steel, titanium, stainless steel, ceramics, various alloys, biomaterials, etc.) and require real technical expertise when marking. Precision objects and medical tools are often small and leave very little space for marking. Despite the small marking windows, the identifiers must be contrasting and visible to allow reading via a vision system and a human.

Another challenge is not to weaken the part nor to change its surface state (essential for bone prosthetics which undergo important efforts throughout their life span). It is also important to take into account all the surface treatments and sterilization cycles that medical instruments undergo. This is why it is essential that the marking carried out is resistant and durable over time.

Laser marking, the most suitable solution for the medical sector

All these constraints make the traceability of medical tools a real technical challenge. SIC MARKING’s aser marking solution consists of emitting radiation from a source, amplifying it and directing it towards the part to be marked. The beam creates a chemical reaction on contact with the workpiece.

This traceability solution, thanks to its many advantages, is becoming more and more widespread in the medical industry. It offers great flexibility of use and is able to mark barcodes, Datamatrix codes, alphanumeric characters and logos. All this while adapting to any material. The high-contrast and durable result obtained allows perfect reading over time for optimal traceability. Finally, Laser marking ensures faultless security because it doesn’t weaken the part and doesn’t degrade its hygiene, a crucial factor in the medical sector.

“Today, the medical sector is a sector where traceability has become essential and necessary. SIC MARKING’s experience in this sector enables us to provide our customers with the most interesting marking solutions from a technical and economic point of view. The wide range of laser marking solutions from SIC MARKING enables us to offer our customers a marking system that meets the requirements of the various types of applications: permanent, non-destructive marking, resistant to the sterilization process, etc,” said Nicolas Louison, Technical Sales Representative at SIC-MARKING.

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