UDI: A New Era in Medical Device Identification

UDI laser marking of medical devices requires special attention to core parameters such as wavelength, power, and focal distance, and the laser must be matched to the material being marked.Routine maintenance includes cleaning the lens, maintaining the cooling system, and regular calibration to ensure the accuracy of the marking and the stability of the equipment.The verification process includes visual inspection, barcode testing, and wear testing, in order to meet the UDI requirements for clarity and durability.

Why are the parameters of the UDI laser marking so important?

UDIs are a requirement of the industry, and are directly related to traceability and compliance.If the parameters are not set precisely, the image may be blurry, or information may be lost. In the worst case, this could affect the approval process for medical devices.Selecting an appropriate laser marking machine and optimizing parameters is the first step in ensuring that UDI codes are clearly legible.

How do the core parameters affect the marking effect?

Matching the wavelength of the laser to the material.

The absorption rates of different medical instruments (such as stainless steel, plastic, and coated surfaces) vary greatly.For example, fiber lasers are best for metal, while CO2 lasers are better suited to plastic and glass.Picking the wrong wavelength can lead to unclear markings or damage to the surface.

Balancing power and marking speed.

If the power is too high, it could burn through the material, while if it is too low, it will not be able to make a clear mark.For example, thin-walled instruments require low power and high frequency, whereas thick and heavy materials can be handled with higher power.If the speed is too fast, the characters will be broken; if it is too slow, the efficiency is low.

Focus control.

A focus error of just 0.1 millimeter would cause the image to be blurry.This is especially useful when marking curved instruments, as the dynamic focusing function can automatically adjust to the curvature of the surface, ensuring that the depth of the characters is consistent.Periodic calibration of the optical system is the basis for maintaining the precision of the telescope.

How can regular maintenance extend the life of equipment?

The laser lenses are cleaned once a month to prevent dust from affecting the quality of the beam.The cooling water must be changed regularly to prevent blockages, and the high temperature accelerates the aging of the laser.It is suggested that a comprehensive calibration be performed every three months, especially for equipment that is subject to heavy loads over long periods.Don't neglect to provide an environment for heat dissipation--leave a space of 30 cm around the cabinet. Poor heat dissipation can lead directly to power loss.

How can you be sure that a UDI is compliant?

First the characters are visually inspected to see if the edges are sharp. Next, a scanner gun tests the recognition rate.We recommend that a sample of the batches be subjected to abrasion testing (for example, 50 alcohol wipes) to ensure that the label is durable.Finally, the data must be checked against the UDI formats published by GS1 and the FDA to ensure that the data is arranged correctly, thus avoiding any problems with the traceability system due to errors in formatting.