Laser Marking for Annual Inspection of Medical Products

For the annual re-inspection needs of laser marking medical products, we provide a complete monitoring program to ensure stability, including equipment maintenance, parameter calibration, and data recording.The company helps medical institutions and production units efficiently complete compliance checks, ensuring that product markings are clear and meet industry standards.

Why should laser-marked medical products be re-inspected annually?

We all know that laser marking on medical products is directly related to patient safety and traceability.But after a while, the laser's power would decline and the focus would shift.If the labels are not inspected in a timely manner, the labels may become blurred or even fall off. If this happens, the company will not only be bothered by the regulatory authorities, but the cost of recalling the products will be a headache.Annual inspections are like giving equipment a full physical examination, and it's a lot cheaper to find problems early than to fix them later.

Three core steps in the monitoring program.

Comprehensive testing of equipment performance.

First the machine is given a "pressure test." After working continuously for four hours, the consistency of the depth of the mark is tested using a standard sample.The key test is the strength of the oxide layer. The label must not fade after 20 swipes with an alcohol wipe.

Dynamic calibration of environmental parameters.

Changes in temperature and humidity have a greater than expected effect on the results of laser marking. We suggest that in the re-inspection process, samples be marked 100 times in each of two extreme environments: high temperature and high humidity (40 ° C / 80 % RH) and low temperature and low humidity (10 ° C / 30 % RH).

A data tracing system is used to verify this.

Now we require every product to have a unique code that can be tracked throughout the production process.Thirty products are randomly selected for testing. Not only is the content of the barcode checked against the database, but also the success rate of barcode scanning.The focus is on checking to see if the label position is off, with a deviation of more than 0.5 mm being enough to cause a failure to scan.

Tips for setting up a re-inspection plan.

1. Don't just aim at the minimum standard: For example, if the standard requires that the label be retained for five years, when testing in practice it is suggested that an accelerated aging test be performed for seven years.

2. Give yourself time to breathe: It is best to start the reinspection two months in advance, so you can give yourself time to make adjustments.

3. Establish a database: All the data from each test, along with the environmental parameters and the information about the operator, should be kept intact so that changes in trends can be easily compared.

This plan has been tried out at several medical device factories with which we have cooperated, and the most direct result is that the rate of non-compliance at annual inspections has dropped from 23 % to under 5 %.The key is to incorporate monitoring into regular maintenance. Don't wait until the end of the year and then try to cram everything in.