The Medical Device Regulation (MDR) changed the requirements for manufacturers that develop medical devices for the European market. The goal of the new regulation is to increase the quality and traceability of medical devices. Accordingly, it influences the processes involved in manufacturing these products and entails additional testing and documentation.
A key component of the MDR relates to permanently legible labelling for medical devices (Unique Device Identification, UDI). The purpose of the traceable UDI code is to enable rapid product recalls within the supply chain – the corresponding information is stored in the European Database for Medical Devices (EUDAMED). Reusable surgical instruments, which may be subjected to repeated autoclave cycles depending on the area of application, represent a major challenge with regard to “permanently legible labelling”.
As a supplier of connectors, assemblies, as well as units for medical technology, ODU supports its customers with laser marking in accordance with the UDI. During what is known as “cold processing”, the ODU connectors (both metal and plastic) are structured using an ultra-short-pulse fibre laser without being subjected to thermal or mechanical influences.
Since the surface structure remains unchanged, the product can be kept clean and sterile. The markings remain permanently legible thanks to their corrosion resistance, stable viewing angle, as well as their structure – even after the specified maximum number of autoclave cycles. The laser markings are also resistant to acids, cleaning agents, and bodily fluids.
“We can implement Unique Device Identification (UDI) by laser marking our plugs. “Furthermore, at ODU we focus on product-related topics, such as patient and user protection, and implement them in compliance with IEC60601-1,” says Mathias Wuttke – business development manager for the medical technology division.
In a complex process, the area in which the wires enter the connector can then be moulded with silicone, resulting in a perfectly sealed yet flexible connection. The silicone overmoulding does not peel off or become detached even after the required number of autoclaving cycles (steam sterilisation at up to 134°C and 3,040 mbar) – its biocompatibility relating to cytotoxicity testing (outgassing) in accordance with DIN EN ISO 10993-5 is confirmed by an external testing laboratory.