ENGLISH 21 assessment with new MDCG guidelines, and usability. Almost 2 years of experience with the MDR has shown: The new regulation is certainly tough, and anyone who blindly sticks to what they are used to is undergoing a great risk. In this article we want to focus on the topic of proof of cleanability and disinfectability and how you can check whether the selected materials and surfaces of the instrument or medical device are durable and suitable over the entire service life. Resistance of medical devices to disinfectants Medical devices need to be prepared for patients and users according to a high level of hygiene. In the medical environment in particular – where the bioburden tends to be higher – infection prevention for protecting patients and staff alike is a widely discussed topic. In order to guarantee and ensure this level of hygiene, medical devices must regularly undergo cleaning, disinfection, and sterilization. Depending on the type and application of the disinfectant, chemical and possibly additional physical stresses will have an impact on the surface of the medical device. • Chemical exposure occurs during wipe, spray, and immersion disinfection. The medical device is immersed in disinfectant for a defined period of time in order to kill any germs present on it. • The physical stress results from abrasion of the device surface during wipe disinfection. The surface of the medical device is disinfected according to disinfection instructions provided by the manufacturer. In summary, it bears mentioning that, when the device is used for many years, its surface will need to withstand all the chemical and physical stresses impacting it. Simulation of several years of treatment with disinfectant led to the dissolution of the coating
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