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Laser marking & engraving
of medical devices
Marking medical devices can be challenging for medical device manufacturers.
Identification tasks become increasingly demanding and the industry's regulations
are getting stricter, such as currently shown by the FDA's (Food and Drug Association)
UDI (Unique Device Identification) directive.
However, manufacturers of marking systems and identification solutions take up the various challenges and multifaceted requirements and develop reliable solutions for medical device marking. Solutions that not only ensure the proper marking of all medical products but are also capable of improving medical device producers' process reliability and efficiency.
Equipment qualification: IQ, OQ, PQ/MQ service
The qualification of machines and equipment is important for process validation in medical technology. We provide extensive support in the installation and qualification of our laser marking machines.
Learn more about our IQ, OQ, PQ/MQ service
Endurance test under real-life conditions: UDI codes still perfectly legible after 500 times of reprocessing
The company add'n solutions GmbH & Co. KG, laser marking service provider and specialist for laser marking on medical devices, has tested the resistance of laser marks on surgical instruments. Marked with FOBA's short pulsed fiber laser markers, the stainless steel instruments remained free of corrosion and the marks were perfectly legible even after 500 cycles of sterilization.
The long-term legibility of laser marked codes has thus been proven for the first time. Until now, no other marking process had undergone as comprehensive a validated testing process of marking, cleansing and passivation, including code verification as well as packaging and labeling.
The advantages, even compared to ultrashort pulse laser marking (with pico or femto second lasers), could be clearly verified. A well coordinated operational process of marking and reprocessing is required: Choosing the right marking parameters is as significant as additional passivation, which is the only way to ensure corrosion resistance, beyond the marked area, to the whole instrument.
Read more in our application case study "Reprocessing of surgical instruments":
Dental implants lasered with microscopic micro marks
Jawbone dental implants bare only tiny surface space, which additionally might not be even but conical or cylindrical. To apply micro 2D-Codes which are machine readable and appropriate for vision-based code verification is challenging.
Manufacturers, medical operators and patients benefit from such micro marks as they enable total traceability, e.g. in case of product recalls or patient complaints. Aside from that they protect from counterfeiting and enable original manufacturing evidence.
Size of the 2D codes: 0.4 x 0.4 mm
Marking laser: FOBA Y.0201/Y.0200-fc
Marked material: metal/titanium alloy
UDI compliant direct part marking of medical devices
The UDI directive, recently introduced by FDA (Food and Drug Administration), requires the unique identification of medical devices in order to provide safe traceability. Medical devices which are used and reprocessed several times over a period of time need a direct marking on the device itself because they are inevitably separated from their packaging. The compliance dates are depending on the device class.
Laser technology is ideal for UDI compliant direct marking: UDI codes, marked with a laser, are biocompatible, clearly legible and permanent. The high-contrast, corrosion resistant UDI marking on the stainless steel umbilical cord scissor was marked by means of annealing with a fiber laser marker.
Laser marking medical devices: Rotary Banding
Banding marks for depth measurement on a hypodermic needle, marked by a fiber laser, wavelength 1064 nm: Many manufacturers request banding marks for depth measurements during surgery. Line marks that function as depth indicators have to be applied around the circumference of cylindrical tube shaped parts such as minimally invasive tools or catheters. These marks show surgeons how far the respective device is inserted into the patient’s body.
The cylindrical devices are marked while they are rotating at a constant speed: The marking is applied by moving the laser along the length of the part while the rotating part generates the equivalent of the cross motion. Bands and alphanumeric contents can be applied in one marking step.
Suitable for catheters, tubes, wires, surgical needles, etc.
Medical Device Marking: Challenges and Solutions
Hygienic laser marking for medical technology: Cannula
Hygienic laser marking of plastics for medical technology with the help of UV laser markers. The product’s surface is colored photochemically. The marking process produces such a low local heating that delicate and sensitive products remain largely unscathed. The surface remains smooth, making it impossible for germs to take root.
With a typical pulse duration of 20 ns and a beam diameter of 10 µm, the UV marking laser colors the surface without damaging it. This process can be used to mark medical products such as cannulas or insulin pumps, and it ensures that the marks are long-lasting and sterilizable.
Height of the marking content: 1.5 mm
Marking time: 11.4 s
Laser marked implantable medical device: Hip-ball
Laser marking of medical implants: Hip-stem
Laser marked implant: Bone plate
Material: High-alloyed implant-steel
Labeling procedure: Laser-aided annealing marking/ black marking
Marking time: 12.75 s
Marking: Logo with filling, font, 2D code
Font size: 1.6 mm
Size of 2D code: 4.4 x 4.4 mm
Marking laser: 30 Watt fiber laser
Laser marked 2D code for traceability of medical devices: Bone screw
Laser marking medical high-grade steel: Kidney dish
Laser-annealed marking on a high-grade steel scalpel
Laser marking medical instruments
Laser marking on medical PEEK devices
PEEK (Polyetheretherketon) is especially appropriate for most medical applications because it is highly temperature resistant and thus can be repeatedly sterilized. Due to its biocompatible properties and its transparent qualities for x-ray examination, PEEK is frequently being used for implants, mesh implants or dental implants. The material is also utilized as grip coating for dental instruments or as insulation for electrical cables.
The best marking results can be achieved with pulsed Ytterbium fiber lasers of the FOBA Y-Series. Especially on small items like spine implants, Y-Series fiber lasers can place micro marks in tiny surface areas which at the same time provide excellent legibility and long term resistance.
The PEEK implant shown aside serves as an interbody spacer for spinal fusion surgery. It has been laser marked with a code to ensure safe traceability throughout its whole product life cycle – from production through to surgery and implantation in the patient.
Size of the 2D-code: 3x3 mm
Marking laser: FOBA Y.0201
Metal implants: Smallest laser marks of highest quality
Pedicle screws and interbody connectors serve as implants in spinal fusion surgeries and are made of Titanium. Due to their field of application, these implants are very small sized so that the space available for marking is extremely limited. Direct part marking (DPM) according to UDI requirements of the FDA (U.S. Federal Drug Association) is required for patient safety and traceability reasons.
Advanced scanning and UDI documentation technologies, such as TRACTUStm from Matrix IT Medical Tracking Systemstm allow for readability of data matrix codes of minimal dimension (down to 0.5mm² with a cell size of 30 microns). This technology is perfectly suited for Direct Part Mark (DPM) validation for Operating Room UDI capture to be processed into hospital documentation.
Best marking results can be achieved with pulsed Ytterbium fiber lasers of the FOBA Y-Series. On small items where there is a requirement for marking tiny codes, surfaces need to be extra smooth (or even polished). Despite their tinyness, those 2D-codes must provide an excellent long-term legibility.
Size of the 2D-code: 3x3 mm
Marking laser: FOBA Y.0201