UDI code Laser marking in the medical industry

UDI code for identifying medical devices

The UDI (Unique Device Identification) code is applied to medical devices to ensure traceability for the benefit of both manufacturers and patients. This code is mandatory and ensures:

image UDI code Laser marking in the medical industry
  • Compliance with quality standards
  • Optimisation of replacement times
  • Improved efficiency and standardisation of instrument sets
  • Analysis in case of loss of theft thanks to localisation

Laser marking on medical devices

Medical device laser marking is widely used for applying UDI codes, as it ensures the highest safety and durability standards. Moreover, laser marking reduces errors considerably and allows the creation of Datamatrix codes (0.5 x 0.5 mm) that are legible even on the smallest devices.

Laser marking on metal and medical plastic complies with all traceability parameters, including:

image-1 UDI code Laser marking in the medical industry
  • Resistance to sterilisation and corrosion (e.g. stainless steel)
  • Hygiene and impalpability
  • Permanence
  • Contrast
  • Anti-counterfeiting

Every stage of the marking process is essential to ensure product traceability, including the choice of a suitable laser marker, its precision, and automation to minimise human errors.

Medical devices can be rejected because the UDI marking is incorrect, or the components are not positioned properly. In this case, costs are considerable.

Usually, the marking of these devices follows the production batch, interfaces with the factory system and creates sequential codes containing information about the place and date of production.

Direct marking in the medical industry has a code system – GS1-128 and GS1 Datamatrix – containing information for traceability purposes.

PowerMark-laser-mopa-lasit-1024x422 UDI code Laser marking in the medical industry

GS1-128 LINEAR BARCODE
(commonly used for UDI data capture)

udi-barcode-1024x338 UDI code Laser marking in the medical industry

DI (Device Identifier)

Mandatory, it is the fixed part of the UDI coding that identifies the product and the specific version or modelPI (Production Identifier)Conditional, is the variable part of the UDI encoding that can include one or more of the following information:

  • Production batch number (10), -> serial number (17)
  • expiry date (15), -> production date (12)
  • distinct identification code for cell, tissue or tissue-based product

Our laser marker uses the following processes to apply these codes:

The UDI code must be visible to the human eye and applied to devices, which can be divided into the following categories:

  • Class 1 devices (low risk)
  • Class 2 devices (moderate risk), such as pumps and syringes
  • Class 3 devices (high risk), such as heart valves, implants and pacemakers

Laser marking on stainless steel, titanium and medical plastic

Usually, medical devices are made of stainless steel, plastic and titanium.

Laser marking processes on steel are by oxidation and ablation.

Detergents, disinfectants, sterilisation and passivation processes can corrode the UDI codes on stainless steel medical devices. A budgeting study of these factors can avoid this scenario, as can setting ideal marking parameters to ensure long-lasting results and unchanged contrast.

Laser marking on titanium, which is known for its resistance to corrosion, oxidises the surrounding air, thus obtaining a dark blue UDI code.

As for plastic, usually test-tubes or thin tubes, LASIT has replaced the UV technology with one that marks all medical devices while maintaining high-quality standards.

fiber-uv UDI code Laser marking in the medical industry
Annealing-UDI UDI code Laser marking in the medical industry
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