The UDI rule for medical devices is a big topic among manufacturers. The deadline for the third phase of the US Food and Drug Administration (FDA) initiated UDI system ends this year.
It affects producers of reusable Class III products such as neurological and cardiovascular catheters and several Class III devices that are single use implants and are sterilised (or cleaned and sterilized) before use.
This includes heart valves, pacemakers and knee prosthesis. Those devices have to be directly marked with a UDI code from September.
FOBA shows economic and efficient laser solutions in Stuttgart for those requirements.
An increase of patient safety was the initial impulse for the FDA’s UDI system, and it now affects every single manufacturer of medical devices who export into the US market.
With a permanent code of high quality and accuracy, authorities are able to trace 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. Concerning the above, FOBA product manager Dr Faycal Benayad-Cherif will talk on April 12 at 2:45pm about UDI and micro 2D codes on miniature medical devices at the Medtec in Stuttgart in Hall 5.
For decades, FOBA has convinced manufacturers of safety relevant components as a successful partner in the field of product marking, especially those that have to meet high standards in traceability.
With FOBA’s patented camera system, Intelligent Mark Positioning (IMP), it is possible to mark a tray with different components at the right place in one go.
The camera, located in the head of the laser, recognises 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, which is 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, avoids faulty marking and allows a better use of workforce.
With the vision-based system, 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 With the quality control immediately after marking within the laser machine, a check through an employee is obsolete.
Attendees of the Medtec can see live laser marking of medical applications such as UDI marking with the laser marking machines M1000 and M2000.
Medtec visitors can experience the advantages of the new lasers for medical devices first hand. An additional highlight is the new generation of FOBA’s Y-Series fiber laser markers.
With the newly developed laser head technology and modular design, it offers integration and application flexibility.
FOBA will be at booth 7D13 at Medtec from 12-14 April.