ENGLISH 23 By using specific disinfectant instructions, it is possible to test the disinfection performance of a disinfectant-material combination. The device is first inoculated in the laboratory with a defined number of bacteria and then disinfected using the instructions set out by the manufacturer. Subsequently, the bacterial bioburden of the device is determined, thereby allowing the performance of the disinfectant to be determined on any particular surface. Development-accompanying disinfectant testing Surfaces are exposed to a variety of influences during use, storage, and transport. Latent weak points can be discovered using surface testing before they are then immediately corrected in the next cycle of development. For example, an adaptation of the housing may require a change in the manufacturing process, which can then lead to higher development and optimization costs. For this reason, it is already necessary to factor this in during the design phase. The control elements, which have an elevated risk of biofilm formation, are particularly critical in this regard. Options for disinfectant testing in the laboratory Disinfectant testing Repeated immersion disinfection Immersion disinfection Annex 1 / Chapter 1 / Point 6 of the Medical Devices Regulation (MDR) states: “The characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user or any other persons is compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses that can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer’s instructions.” Wipe disinfection The disinfectant is distributed over the surface by wiping. This is done for the material analysis. The instruments are immersed in the water-disinfectant mixture several times and removed again. After repeated immersion, it is then checked whether the material is resistant to years of repeated disinfection. All instruments that need to be disinfected are placed in a tub filled with either water or disinfectant. After a certain time, the instruments are then removed from the tub and their material resistance is checked.
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