How Medical Industry Manufacturers Can Meet FDA Traceability Requirements

How can the medical industry use laser marking technology to meet the new regulations? This article discusses how to apply laser marking technology to medical products, including choosing the right equipment, managing data, and verifying procedures. It provides a practical solution that meets the requirements of UDI, helping manufacturers efficiently meet the challenges of regulation.

What makes laser marking a necessity under the FDA's new rules?

Recently, I was chatting with the owners of several medical equipment factories, and I discovered that the FDA's new traceability requirements are their biggest headache.In the past, ink or labels were used to mark the fish, but they would fade or smudge, so that when the fish was checked it was found to be "untraceable.One manufacturer of surgical forceps complains: "Last year we lost over NT $ 100,000 in reworking and relabeling!

The FDA's requirements for UDIs are actually quite simple: permanent and readable.Laser marking directly etches information into the surface of a product, so it can't be removed by alcohol or high-temperature sterilization. Compared to traditional methods, it is clearly superior.But there's a problem. You can't just buy a laser printer and be done with it. There are a lot of technicalities involved.

Three keys to choosing the right laser equipment.

The right materials are the key to success.

The last time I went to a trade show, I saw a certain manufacturer stamping stainless steel pins with very clear markings. But when I bought it to stamp titanium alloy joints, it turned into a mess.The absorption rates of different metals for fiber and CO2 lasers are very different, and for PEEK, the material most commonly used in the medical industry, a specific wavelength is needed.I suggest that you first get a sample and do a compatibility test, rather than just looking at the data sheets.

The software must be able to link to the UDI database.

The most unjust case I've ever seen is one where the equipment had a great effect, but because the software couldn't automatically synchronize with the FDA's GUDID database, the codes for each batch had to be manually entered.Most mainstream laser equipment has ERP / MES interfaces, and the key is to check whether the equipment supports GS1 standard encoding formats and automatic version updates.

The certification documents are more valuable than the machines themselves.

Last year I helped a friend inspect equipment, and the manufacturer's report was only two pages long. The FDA sent it back.The verification package should include a diagram of depth of mark, data on 10-year accelerated aging testing, and statistics on reading success rates at different angles.Remember to include in the contract that the IQ / OQ / PQ documents are to be included.

A guide to avoiding pitfalls.

The workshop environment is no small matter.

One company found that during the rainy season in the south, the labels on the bottles would always turn black. It was finally discovered that the humidity was so high that condensation was affecting the lens.The best temperature for a medical products printing room is 25 ° C ± 2 ° C, with humidity between 40 and 60 %. Don't skimp on air conditioning and dehumidifiers.

Training must be concrete and realistic.

Don't just teach them how to operate the buttons.In practice, I have encountered workers who have put labels on products that have not been properly dried. The chlorhexidine solution left on the surface causes the labels to turn yellow.I suggest making a flow chart for the process of "washing-drying-labeling-inspecting" and posting it on site.

Regular maintenance should not be a mere formality.

In one case, a company used a laser for three years without maintenance, and one day the machine suddenly stopped printing production dates on the products. The entire shipment was held up at customs.The maintenance cycle should not only be based on the manufacturer's recommendations, but also take into account actual production. For example, if equipment is in continuous operation for eight hours a day, the frequency of filter changes should be 30 % higher than the manual recommends.

The most frequently asked questions are answered.

Last week, we collected a few typical questions from the industry.

Q: Can existing spray coders be upgraded?

A: Why not just buy a new one? The cost of upgrading often exceeds 60 % of the price of a new computer, and there is a risk of compatibility problems.

Q: What is the smallest font size that can be printed?

A: At present, laser equipment for medical use can achieve a 0.2 mm character height, but one must take into account the readability of the code after cleaning the instrument following surgery.

Q: What does the FDA focus on most in its review?

A: Last year 78 % of the cases of non-conformity were related to the requirement that the data be readable 10 years later. The focus is on preparing aging test reports.

In the end, let me say this: It's true that it costs NT $ 200,000-NT $ 300.000 to install a laser marking system. But compared to the risk of having production halted for failing a flight check, it's a small price to pay.After all, no one wants to be the next company to be blacklisted by the FDA for a traceability problem, right?