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Abstrakt

Evaluation methodology of medical safety device

Rosa Maria Orriols

Evaluating safety medical devices. We chose to do the presentation in two parts: Technical report on Needle stick and cutting material in ICS. Territorial Program to monitor the SMD. The First part was developed with a multidisciplinary team from different hospitals and primary care from Institut Català de la Salut. The Methodology was published in NTP 875 Biological risk: methodology for the evaluation of sharp and cutting equipments with built-in biosafety devices. Spanish Government and WHO Manual on Selection and Evaluation Medical Safety Device. Results: 61 products have been evaluated, 11 wasn’t accepted, 13 past only the first phase, 12 Not guaranteed safety it the event of human error and safety in the event of foreseeable misuse, is partially guaranteed; 21 was in the category of very good, and 4 safety medical device guaranteed the safety user during all life product. In the analysis of all material use in Institute Català de la Salut 40’63 % was needlestick; 14, 53 % was scalpel, any was in safety medical device category. 32, 29 % was catheter and 12, 90 % was in safety medical device category; any trocar (5,21 % material) was in the safety medical device; 4,17% of all material was lancets, and 50% was safety medical device. Syringes with needles was 3,13% , any syringes was in safety medical device category.