Development of a validated procedure for manual reprocessing of an instrument for endoscopic interventions
Laufzeit: 01.01.2016 - 31.12.2018
Kurzfassung
Due to the standardizability, reproducibility and thus validability, hospital hygiene prefers automated instrument reprocessing in clinical medicine. However, there may also be situations in which only manual reprocessing is possible. In this case, the Medical Devices Act also requires the application of a validated procedure. The aim of the project is the establishing of a reprocessing instruction for clip applicators used in endoscopy. The data required for this are initially developed in...Due to the standardizability, reproducibility and thus validability, hospital hygiene prefers automated instrument reprocessing in clinical medicine. However, there may also be situations in which only manual reprocessing is possible. In this case, the Medical Devices Act also requires the application of a validated procedure. The aim of the project is the establishing of a reprocessing instruction for clip applicators used in endoscopy. The data required for this are initially developed in laboratory experiments with chemical protein determination and microbiological tests. Subsequently, they will be checked in clinical practice.
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