Stesura ed esecuzione di type test in conformità alla normativa UNI EN ISO 15883 per dispositivi medici di lavaggio e disinfezione

The successful reprocessing of reusable medical instruments is a fundamental requirement for an efficient healthcare system. Steelco is one of the main manufacturer of the reprocessing devices which are installed in a Central Sterile Supply Department (CSSD). Such machines must respect appropriate requirements and must be declared compliant to a rigid technical standard regulation. This technical standard is constantly modified and updated. This is the reason why one of the main activity in Steelco Test Laboratory is the testing of the devices following rigid protocols specified in the technical standard itself. The role of the Test Laboratory is fundamental to keep the company strong on the market. The first part of this dissertation describes the medical instruments reprocessing in a CSSD, focusing on the thermal disinfection stage, and it contains the technical analysis of one of the most sold Steelco devices. After that, the focus is moved to the technical standard regulations, specifying how it is structured and what it establishes for the washer-disinfector design and testing. The completed drafted test report which must be submitted to obtain the conformity of the devices is then illustrated, containing all the executed tests with their results. The last part of this work deals with another important Test Laboratory activity: the technical analysis of competitor device. In particular, a Chinese competitor machine is described and the tests carried out on it are reported. This machine has been compared with the already described Steelco device. For example, the cleaning efficacy tests and the consumption tables have been discussed for an efficient comparison.