TRACEABILIT Y
TRACEABILITY IN THE MEDICAL SECTOR, A 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.
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hanks 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. MORE INFORMATION
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. 25 | Industry EMEA | July 2020
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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 really 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. Benoit Massel, specialist of laser marking technology at SIC MARKING talks about it: “All the difficulty of permanent marking by laser technology on medical parts lies in the ability to obtain a contrasting
