Medical Equipment Laser Marking: Clarity and Sterility

In the production of medical instruments, laser marking must meet the hard standard of clear labeling, as well as strict requirements for asepsis.From the standpoint of practical applications, this article discusses how to choose the right laser device, optimize parameter settings, and verify the sterility of the process.

Why must medical devices be so stubborn about these two points?

We all know that surgical forceps and implants and other medical devices have identification marks on them like "ID cards.If the label is blurred, the medical personnel may pick the wrong type of blood; if the label is contaminated, the patient's safety is directly threatened.That is, you need both sterility and clarity to avoid playing with fire.

Three things to avoid when selecting equipment.

When the wavelength is right, the effect is multiplied.

Stainless steel is best cut with fiber lasers, and plastic with UV lasers.Last year a factory tried to cut costs by using the wrong machine, and ended up with a batch of titanium alloy bone screws whose serial numbers were all smeared when they were disinfected. The company lost over NT $ 200,000 in orders.

Don't be fooled by the "sterile cabin" gimmick.

To meet GMP standards, the equipment must have a real-time air-purifying system.Some companies promote "sterile labeling," which basically involves installing a simple dust cover. This kind of equipment would never pass a cleanliness test.

Software must be traceable.

Now flight inspectors are constantly checking production logs.He recommends a control system with an automatic recording function, so that the parameters used by a particular batch can be retrieved at any time.

The secret of parameter tuning.

Speed versus depth.

If you go too fast, the characters will be blurred, and if you go too slowly, the material will burn.As an example, 304 stainless steel is best machined at a speed of 1200 mm / s with 30 % power, which allows for an etching depth of 0.1 mm without damaging the passivation layer.

The hidden skills of assist gases.

The nitrogen purge is no small matter, as the nitrogen prevents oxidation of the materials, which affects the quality of the markings, and also carries away the waste from the manufacturing process.One IV manufacturer has reported that after using nitrogen to protect the product, the number of microbes present was directly reduced by 80 %.

Verification of sterility must not be a mere formality.

There are certain rules to the placement of the samples.

When testing, you can't just take samples from the surface of the equipment.The most important part to check is the indentation left by the stamping, which is the most likely place for dirt to accumulate.Last year there was a case where a CE certificate was not awarded because the manufacturer failed to test the threads of the screws for bacteria.

The best strategy is to simulate a battle.

After completing the routine tests, they are advised to go through a simulated hospital disinfection process.One customer reported that a batch of catheters that had been sterilized with ethylene oxide had laser markings that had faded and fallen off.

Documents must be able to withstand close scrutiny.

The inspection report can't just say "Pass" in two words.Experts from the FDA will even look at the details of the environmental temperature and humidity, the qualifications of the operators, and the models of the testing equipment.