Laser Marking Solutions for Medical Device UDI Compliance

UDI is a hard requirement for the medical device industry, and laser marking technology, with its advantages of permanent marking and high precision processing, is the preferred solution.Different materials require different wavelengths, and the key criteria are durability and compatibility with sterilization.Real-world cases show that selecting the right laser marking solution can improve the pass rate of markings to over 99 %, effectively meeting the traceability needs of medical devices throughout their life cycle.

Why are UDI labels so important for medical devices?

Now every piece of equipment in a hospital has a "national identification number," which is the UDI.It's like an electronic medical record for medical devices, allowing them to be traced from the factory to the patient.Last year, when a hospital in a certain city recalled some of its medical equipment, it was the UDI system that allowed them to pinpoint the problem batch in 48 hours.

The government's hard-line policy.

The CFDA has clearly stated that second- and third-class medical devices must have a UDI.The recent inspection found that 15 % of the equipment marked with traditional ink-jet printers had blurry marks, while the pass rate for laser marks was 99.6 %.

What makes laser marking the preferred option?

Compared to the traditional method of sticking a label on the instrument, the laser method "engraves" the information directly onto the surface of the instrument.For example, fiber lasers can mark titanium alloys used in orthopedic implants in 0.8 seconds without damaging the surface.

What's so great about this technology?

One real example is that of a manufacturer of stents, which after switching to UV lasers saw its marking speed increase threefold and its failure rate drop from 0.5 % to 0.01 %.In particular, when dealing with high-molecular materials, cold processing techniques do not cause heat deformation.

How to choose a reliable laser marking system.

First, look at the material of the medical devices. Stainless steel devices are suitable for fiber optic lasers, while high-molecular materials are better suited to ultraviolet lasers.One well-known endoscope manufacturer's selection experience is worth noting. They compared eight suppliers, and finally chose to go with a model with a visual positioning system, which directly increased the rate of good products.

Three traps to look out for.

First, you need to verify the depth of the marking. If it's too shallow, it will be easily worn off, and if it's too deep, it will affect the strength of the instrument. Second, you need to test the clarity of the marking after sterilization. Third, you need to make sure you can use GS1 standard data formats.