The Best Systems for Precisely Laser Marking Surgical Instruments

The FDA requires UDI marks to be easily read by both machines and humans. Since surgical instruments are constantly being sanitized and come in contact with bodily fluids, it is essential that the traceability mark can withstand this and stay visible. Laser marking surgical instruments ensure visibility by using focused light to create permanent and precise marks that are fully permanent and will not fade over time, unlike older marking methods like stamping and printing that can wash off and fade away.

A common traceability mark for surgical instruments is a 2D code because of how much information can be stored inside. Laser marking surgical instruments with 2D codes is commonly performed using an "annealed" style mark. This is created by de-focusing the beam to create a high contrast, damage free mark. This is especially important in the medical industry, where products often go through passivation and other harsh testing conditions. These annealed marks can survive the most daunting test cycles without adding any additional complexity or opportunities for failure.

During a surgical procedure, eliminating contamination is essential to the patient’s and medical professional’s health and safety. Since laser marking is a non-contact marking style, the opportunity for contamination or product damage is greatly reduced from that of conventional marking methods.

When choosing a laser marking system, considering what material the surgical instrument is made of will determine the type of laser. Medical manufactures commonly use multiple metals as well as plastics and resins - each of which can be laser marked with a high level of quality.

Metal and resin differ in reflection and heat resistance. When working with metal, using a high-powered laser for laser marking surgical equipment will achieve high contrast. Alternatively, resins tend to react better to a lower power, higher absorption rate laser such as the MD-U.

The 3-Axis Hybrid Laser Marker MD-X Series is a top system for marking metal surgical instruments. It combines the high-quality beam of a YVO₄ laser and the high output of a fiber laser, greatly reducing the opportunity for any heat damage to the part.

The MD-X moves fast in a production line with a high peak power and short pulse duration. Additionally, the MD-X has a long service life and can account for up to 42 mm in Z-height deviation. Altogether, MD-X’s properties limit thermal damage and mark efficiently, precisely, and permanently.

The 3-Axis UV Laser Marker MD-U Series is also a top system for laser marking medical devices. The MD-U creates high-contrast, damage-free marks on a wide range of materials. It has a much shorter wavelength than most laser marking systems. This leads to a much higher absorption rate, meaning significantly less power actually needs to be applied to the product. The medical industry has very firm policies on what is an acceptable medical device. This dramatic reduction in power or heat being applied to medical devices can often be a differentiator in regulatory approval.

Whether you choose the MD-U or the MD-X, all of KEYENCE’s lasers contain specialized systems that outperform conventional laser markers.

Each KEYENCE laser has an internal 3rd axis which allows best-in-class beam control. Where most laser markers can only mark on flat 2-dimensional devices, KEYENCE lasers are able to account for 3D surfaces by automatically adjusting the focal point of the laser. Even more, the full-view camera on these lasers will analyze the shape of the instruments and mark uniformly across the instrument.

Additionally, the MD-U and MD-X come with Marking Builder software, making laser marking even more automated and user-friendly. Marking Builder can build 2D codes and automatically index data without the need for any external software.