Well equipped for the new MDR

Even smaller medical products, such as guide wires here, can be densely packed and economically cleaned using the new LPW technologies. (Photo: iStock)

In a few months, the new Medical Device Regulation (MDR) will come into full force. The regulation places greater emphasis on traceable processes to ensure the quality of medical products. The question of whether the product also works as promised is given significantly higher priority. This also impacts the industrial cleaning of corresponding devices and instruments and calls existing procedures into question. Small and medium-sized manufacturers are not yet fully prepared for this transition. How the shift to the future of precision cleaning can succeed based on MDR requirements and beyond was presented by LPW Reinigungssysteme GmbH at the "T4M – Trade Fair for Medical Technology," which took place for the first time in Stuttgart from May 7 to 9.

LPW CEO Gerhard Koblenzer: "Especially with complex geometries, such as those created by additive manufacturing, well-established cleaning methods like ultrasound reach their limits. These procedures can no longer be used for all tasks in medical technology in the future." Therefore, LPW engineers started developing new solutions years ago, and these are now established in the market. One example is the CNp technology, which demonstrably cleans independently of geometry down to the smallest detail and reliably reaches the specified limits even with densely packed goods or additively manufactured components.

Furthermore, LPW is actively involved in numerous research and development projects concerning new rinsing and drying procedures as well as traceable process management. As a member of clusters such as MedicalMountains in Tuttlingen or through participation in a DIN standards committee on the purity of medical devices in the manufacturing process, the Riedering specialists are directly involved in change processes.

Koblenzer: "Technical cleanliness in processes and on the respective component is a key product property. It has a significant impact on the safety and functionality of medical devices."