The medical Device Directive 93/42/EWG implements as an essential requirements that "medical devices should provide a high level of protection and attain the performance level". For the cleaning stage of the reprocessing cycle no online quality assurance method for hidden surfaces like the inside of a tube is known. The objectives of the study are to develop a detection system to quantify contamination inside flexible endoscopes, which allows a sensitive online diagnosis. Specially designed fluorescent markers which bind preferentially to possible contaminations are detected using techniques of laser induced fluorescence to provide quantitive information on surface contamination .The system to be developed on one hand will be used in clinical routine and on the other hand should enable manufacturers to optimise their products and validate a cleaning process.
Funding SchemeEAW - Exploratory awards
28223 Pozuelo De Alarcon