In 2007, Congress passed legislation directing the FDA to develop regulations establishing a unique device identification (UDI) system for medical devices.
Part marking helps the FDA identify product problems quickly, target recalls better, and improve patient safety. Part marking also enhances the quality of the information in adverse event reports for medical devices.
Laser Technology for Part Marking in the Medical Industry
Laser technology as a precise and highly selective material processing method is steadily gaining importance in the medical industry. Laser technology can mark a medical device component without damaging the chemical passivation. The resulting marked surface maintains its anti-corrosive coating and prevents germs from embedding within the material, even after years of usage, cleanings, and sterilizations.
Marks for Permanent Identification
Many products need barcodes to identify them for subsequent automated tracking processes. These codes can contain large amounts of data such as serial numbers, part numbers, place, and date of manufacture. Because marking space is not limitless, a laser marker is beneficial since it can produce a highly resolved ID/2D metric code of greater than 20 characters into an area of a few millimeters.
Marks must be permanent to be completely readable and traceable throughout their life cycle, from the manufacturing site where the device was produced to the operating room where the device is used or implanted on a patient.
Accuracy in Medical Part Marking
Medical manufacturers must ensure that the correct information is marked on the correct part in the right location and that this identifying information is legible at any time. All marks must meet accuracy specifications; poorly marked parts must never make their way to the patient.
Medical device manufacturers are trying to achieve “zero defect marking.” Medical devices are usually marked at the end of the production process. By this point, scraping products because of incomplete or incorrect markings is extremely costly.
So it is essential to tightly control the marking process to prevent bad marks from being placed on the part, correct marks from being placed on the wrong position, or making marks that cannot endure cleaning, sterilization, or passivation.
Do You Need Laser Marking On Your Parts?
Integrated Technology Inc. offers state-of-the-art design, engineering, and marking for all types of materials and part configurations. In addition, our in-house 3D printing capabilities allow us to fixture even the most difficult parts.