UDI (Unique Device Identification) made easy – with the turnkey complete package from TRUMPF
Nowadays, more and more medical technology products must be clearly marked with a UDI code (UDI = Unique Device Identification) that can be traced over the entire supply chain. The most important requirement is that this identification remains legible at all times – something that can often only be achieved through laser marking. In addition to a wide range of marking lasers, TRUMPF also offers customizable software solutions. Customers can use these to create correct UDI identifiers from the contents of their database systems, and apply them to the medical product – with subsequent quality control and documentation by request. This complete package means TRUMPF customers receive not only reliably high marking quality, but also benefit from TRUMPF's solutions for UDI-compliant marking, process reliability, as well as support during equipment qualification (EQ) in the course of installation qualification (IQ) and operations qualification (OQ).
What is UDI (Unique Device Identification)?
UDI identification consists of two parts – a machine-readable code and a code that can be read by humans. The machine-readable part is either a linear barcode or a two-dimensional Data Matrix Code. The part read by humans can consist of numbers and letters. The UDI code also consists of both a static and a dynamic part: the static part is a unique, specific code for the respective product, while the dynamic part changes based on variable information such as serial number, product batch, or the expiry date. In order to guarantee that the medical products are traceable, accredited standards are applied. Very commonly used standards include GS1, HIBC, and ISBT 128.
What does TRUMPF offer in terms of UDI?
TRUMPF offers a turnkey complete package for UDI-compliant laser marking on medical products, which the customer can use to seamlessly integrate marking lasers into the UDI process. In addition to the laser, the solution consists of a UDI software module. Both components are supplied by TRUMPF and are therefore optimally compatible with each other.
Step 1: TRUMPF offers standard database connections based on the respective wishes and existing databases of the customer. TRUMPF can also provide individual interfaces programmed by TRUMPF experts for implementing the complete UDI software solution. Alongside the data input via the databases, there is also the option of reading in information into the system by connecting external manual scanners.
Step 2: The TruTops Mark Module Interface (TTM-MI) connects the customer-specific databases or control systems with the marking laser.
Step 3: The UDI module generates the code from the UDI-relevant data as well as the individual customer enhancements.
Step 4: VisionLine image processing automatically recognizes the component as well as its exact position. Defective parts are avoided, as the software forwards the information to the control system and ensures that the marking is always placed in the correct spot.
Step 5: The TRUMPF laser marks the workpiece with a permanent, high-contrast marking, which can still be read by both machines and humans after numerous cleaning cycles.
Step 6: The subsequent quality control is also made easy using TRUMPF process sensors. The different camera solutions (on-axis/off-axis) allow UDI–compliant codes to be recognized, read out, and be subjected to a quality assessment.
Step 7: The marked data on the component is then compared with the database and thus checked for accuracy. Finally, if desired, an image of the marking and an individual report of the UDI-relevant information (e.g. content of the UDI code, quality assessment regarding the UDI code) and machines (e.g. operator, time, laser, parameters) can be saved to the database for documentation purposes. This guarantees that the components and their markings are documented, even after many years.
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The advantages of the TRUMPF complete solution for UDI-compliant markings
To guarantee compliance with legal requirements stipulating that medical products must be traceable, the markings on the products must be permanently legible. TRUMPF has a wide selection of marking lasers which provide the required marking quality for every type of material.
The marking software prepares the marking content depending on the official regulations and guidelines. This eliminates the risk of errors that comes with manual input. Additionally, the image processing system automatically finds the position of the marking content on the correct component and checks the marking content.
Regardless of where the data for processing comes from, or where it is ultimately saved for documentation purposes – the TRUMPF solution integrates internal and external data processing workflows, either by means of standard modules or using a concept which is tailored to the customer.