UDI MARKING ON MEDICAL COMPONENTS

UDI MARKING ON MEDICAL COMPONENTS

The Medical sector has to respond on many requirements in respect of hygiene, quality and safety. Guaranteeing patient safety, these numerous constraints are more and more governed by standards, which are essential for the implementation of effective traceability processes.

In 2013, the FDA (Food and Drug Administration) set up the UDI marking (Unique Device Identification) which aims to identify all medical components, from their manufacture to their use by the final customer. This standard is also imperative for the export of surgical components to the United States. The European Union has recently adopted its own standard through the MDR marking (Medical Device Regulation).

The UDI marking is composed by two unique identifiers:

  • Machine readable: 1D barcode or 2D Datamatrix code.
  • Human Readable: represented by an alphanumeric marking.

The elements to be marked are as diverse as the professions that make up the medical sector. For example, there are many cases of marking on instruments, such as scalpels, which are an essential tool used in many surgical procedures. But also bone prostheses, made of steel, cobalt, ceramics or biomaterials, dental implants, often made of titanium, or hearing aids.

 

 

THE TECHNICAL CHALLENGE OF UDI MARKING

Directly applied on medical components, UDI markings face various constraints linked to the complexity of the devices to be identified, making a real technical challenge of traceability in the medical sector.

These difficulties could be:

  • The nature of the materials :
    • The materials used in the manufacture of medical devices are particular. They are often hard materials such as steel or titanium or complex to mark, such as stainless steel, ceramics, cobalt of different types of alloys.
  • The marking zone size :
    • Precision objects, the medical devices are often small and leave very little space for alphanumeric, barcode or Datamatrix marking.
  • The life duration of marking:
    • The materials to be marked endure numerous surface treatments or sterilization processes throughout their life. For that reason, it is essential that the marking is resistant and durable over time.
  • The marking contrast:
    • The UDI markings, composed of a barcode or Datamatrix, as well as an alphanumeric code, must be contrasted and easily visible in order to facilitate reading by a vision system or by a human.
  • Do not deteriorate the integrity of the part:
    • Surgical components and devices endure significant stresses and strains – in particular with bone prostheses. Therefore, it is important that the UDI marking doesn’t weaken the part to which it is applied.

 

 

PRODUCTS ADAPTED TO UDI MARKING

SIC MARKING, the traceability leader for more than 30 years around the World, proposes its perfectly adapted laser marking solutions to UDI standards. This technology, highly regarded in the medical sector offers many advantages:

  • Quality of marking
    • Laser marking offers contrasting results for an easy reading.
  • Flexibility
    • SIC MARKING lasers are suitable for the majority of materials, from the hardest to the most complex.
  • Security
    • Annealing, a technique that consists of heating the material locally using a laser beam, without creating harsh qualities favourable to the development of bacteria. This ensures that the part is not weakened by possible contamination.

The SIC MARKING laser product range meets your needs, regardless of the type of marking required or the production environment (serial or single-unit). It consists of lasers that can be integrated:

  • Laser i104 EASY
  • Laser i140 HD

Different marking machines:

  • L-BOX
  • XL-BOX
  • XXL-BOX (available in 3 further widths)

As well as numerous options:

  • 3D marking
    • Whatever the complexity of the part (height variation, angled, recessed or rounded surface), the 3D laser marking system ensures uniform and high quality marking.
  • Vision system
    • The reading camera is integrated into the laser marking head, which allows a fast and infallible reading of your 2D Datamatrix.
  • Rotational D-Axis
    • Perfectly adapted to all cylindrical parts requiring marking.

SIC MARKING manages the customer’s needs, and gives personalised support throughout the project and has many references in the medical sector.

Submit your marking project to us, we will probably have manufactured a similar solution in our many years of experience in the medical sector allowing us to offer you a proven and validated solution. Our technical teams will also be able to Project manage a bespoke custom solution for you that will fit perfectly into your manufacturing process.