Unique Device Identification ensures traceability
The FDA legislation requires a Unique Device Identifier (UDI) marked directly onto the medical device itself to provide traceability along the entire supply chain.
It must contain plain text which is readable by humans as well as machine-readable code. Both must be permanently legible since traceability is of the utmost importance for medical implants and surgical devices.
This type of marking can be provided by an ultrafast laser which can deliver a smooth mark with very high contrast.
Marking of all kinds of material
Medical devices can range from implants and catheters to less invasive multi-use surgical tools such as scissors, forceps, and scalpels.
Typically, materials used in the manufacture of medical devices are:
All can be marked using our ultrafast laser.
Cost-effective permanent marking
Most marks are required to remain durable after regular use and cleaning, which makes laser marking ideal.
Laser marking is a very attractive and cost-effective marking solution due to the process reliability, the non-contact nature, the inherent flexibility, the capability to create intricate details, the micron precision – and no need for consumables.
Why use ultrafast lasers?
Ultrafast lasers exhibit many advantages over nanosecond lasers. Their short pulse duration provides an exceptional peak power which enables marking of a wide range of materials without delivering heat to the material. This significantly reduces the unwanted thermal effects of traditional laser marking, which can lead to poor corrosion resistance.
Medical device markings are required to repeatedly withstand the high temperature and humidity autoclave cleaning and sterilization technique. Conventional thermal laser marking typically exhibits issues relating to fading and corrosion when subject to repeated cleaning.
Ultrafast lasers create smooth marks which have proven to survive numerous cleaning cycles. During ultrafast laser marking, no material is removed and there is no microcracking or surface damage.
The ultrashort pulses produce nanostructures on the surface of the medical device which is particularly efficient at light trapping and hence provides the high-contrast matt black “printed” appearance.
The marking can be seen clearly from every angle and is completely smooth. Multi-use medical devices present a risk of spreading contaminants, so a smooth surface, free from biological traps, is essential.
The ultrashort pulses delivered by NKT Photonics’ ultrafast laser range are well suited to marking in the medical industry and fulfilling the requirements for UDI-compliant marking.
The ORIGAMI XP is the first all-in-one, single-box, microjoule femtosecond laser on the market. The laser head, controller, and air-cooling system are all integrated into one small and robust package, with a footprint so small it even fits into a hand-luggage!