The UDI rule for medical devices is a big topic among manufacturers. The deadline for the third phase of the U.S. Food and Drug Administration (FDA) initiated UDI system ends this year. It affects all producers of reusable class III products – such as neurological and cardiovascular catheters – and several class III devices that are single use implants and are sterilized (or cleaned and sterilized) before use – such as heart valves, pacemakers or knee prosthesis. Those devices have to be directly marked with UDI code from September 24, 2016, forwrad.
An increase of patient safety was the initial impulse for the FDA’s UDI system. Now it affects every single manufacturer of medical devices who export into the U.S. market. With a permanent code of high quality and accuracy the authorities are able to trace back a problem device to its manufacturer and check other devices of the same cycle for safety issues. The European Union is working on a similar directive.
With FOBA’s patented camera system IMP (Intelligent Mark Positioning) it’s even possible to mark a tray with different components at the right place in just one go. The camera, located in the head of the laser, recognizes almost identical products and their location in the tray, automatically aligns the mark to the parts and marks them at the correct position. Immediately after marking, the camera verifies the readability and validity of the mark. This is especially beneficial for automotive parts and medical device manufacturers.
Laser marking machines with the integrated camera system IMP show an improved efficiency compared to other marking solutions. The system reduces scrap significantly. It avoids faulty marking and allows a better use of workforce. With the vision-based system the positioning times after a cycle change is reduced significantly. With the quality control immediately after marking within the laser machine a check through an employee is obsolete.
UDI marking is achieved easily with the Foba laser marking machines M1000 and M2000.
Source: FOBA