Laser Marking in the Medical Industry

Medical laser device marking refers to the process of engraving or permanently marking medical devices with identifying text and/or images. This can include serial numbers, barcodes, logos, and other unique device identifying marks. Laser medical device marking is an alternative to traditional medical device markings such as printing or stamping.

These device markers offer many benefits over traditional methods including faster marking speed, the ability to mark small or difficult to reach areas, and cleaner and more consistent marks. Additionally, laser marking medical devices provide high resolution marks, utmost accuracy, flexibility, and overall operational efficiency.

• Reduce manufacturing costs by creating custom programs that adjust for design and part changes.
• Laser marking creates permanent, high-contrast marks without the use of ink.
• Marking can be performed during the manufacturing process, which eliminates the need for extra machinery and additional processing time.

With KEYENCE's Z-MAP Creator software, 3D CAD data (STL format) can be imported directly into the Marking Builder software. The data can then be used as a foundation for three-dimensional marking. Characters and logos can easily be marked on even the most complex shapes with just the touch of a button. Because of its ease-of-use and high functionality, Z-MAP Creator has become an essential tool in surgical device manufacturing.

Laser markers are used to create identifying marks (like 2D codes) on surgical equipment. These marks are highly visible, don't wear off and can't be erased by chemicals (which is a common problem with pad printers).

Laser markers can mark both metals and plastics, and they're commonly used to create identifying marks on polycarbonate medical tubing. This identification process is typically accomplished with labels, but they are expensive, take time to produce and run the risk of falling off or being removed. Laser marking eliminates those risks and the costs associated with each.

Laser marking intravenous bags creates a permanent, easy-to-read mark. Date codes and serial numbers are common marking examples. Ink printing (which is a common marking alternative) easily wears off and heat stamping is not clearly legible. Replacing either system with a laser solves both issues and eliminates the costs associated with maintenance and consumables.

Laser markers can also be used on catheters and hypodermic needles. Cut locations and dwelling positions can be marked in the fluoride coating. Ink systems are commonly used to create these marks, but there's a risk the ink will contaminate the product. Laser markers remove this risk since no chemicals are used in the marking process.

Medical laser marking is mandated and regulated by the FDA in the United States and the corresponding medical regulatory bodies in other countries. The FDA has established guidelines for unique device identifiers, or UDIs, which must be followed by medical device manufacturers and labelers or markers. These guidelines include specific requirements for various medical device types, such as Class 1, Class 2, or Class 3.

As the FDA site states:

“The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.

When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation (source).”

These identifiers consist of the device identifier, which is the mandatory mark to identify the device’s version or model. Next is the production identifier, which may include a lot or batch number, serial number, expiration date, and manufacturing date. In order to implement these UDI’s, an accurate laser marking machine that is customized for these specific medical-related requirements must be used.

Following the FDA guidelines is essential to ensure patient safety and avoid unnecessary regulatory issues.