Publication: Gestión de riesgos de productos sanitarios
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2015-10-09
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2015-10-09
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Abstract
En el presente Proyecto Fin de Carrera se analiza la gestión de riesgos de los productos sanitarios embarcados y susceptibles de uso por parte de la tripulación de un helicóptero de búsqueda y salvamento perteneciente al 802 Escuadrón de FFAA / RCC de Canarias, del Ejército del Aire del Reino de España.
OBJETIVO: Analizar la gestión de riesgos que se ha realizado a los productos sanitarios embarcados en un helicóptero de búsqueda y rescate del Ejército del Aire, cumpliendo con las especificaciones demandadas por los estándares internacionales sobre la gestión del producto sanitario. Complementariamente, comprobar el cumplimiento de la legislación vigente relacionada con el producto sanitario en el puesto de trabajo (enfermero militar en un helicóptero de búsqueda y rescate).
MATERIAL Y MÉTODO: Estudio descriptivo, de observación, retrospectivo y transversal. Grabación en soporte informático (Excel®) del método AMFE. El ámbito es la población de las Islas Canarias, con una población de 2.118.679 habitantes, y una extensión de 7.447 km². Los equipos analizados son los habitualmente embarcados como dotación en los helicópteros de servicio, y la información técnica de cada producto sanitario ha sido directamente obtenida de la página web del fabricante.
RESULTADOS: Se han analizado un total de 13 productos sanitarios. Primero realizando una descripción de procesos y actividades, posteriormente un análisis normativo de equipos (verificando que cada producto cumple con los requisitos esenciales indicados en el anexo I del Real Decreto 1591/2009, de 16 de octubre, por el que se regulan los productos sanitarios), y por último, se realiza un análisis de la gestión de riesgos sanitarios siguiendo el método AMFE.
CONCLUSIONES E IMPLICACIONES PARA LA PRÁCTICA: Todos los productos analizados poseen el marcado de conformidad CE, por tanto cumplen con los requisitos esenciales de la normativa. Finalmente se acompañan unas recomendaciones sobre operatividad.
INTRODUCTION: In this Thesis, it has been anylised the risk management of medical devices shipped and capable of use by the crew of a search and rescue helicopter belonging to 802 Escuadrón de Fuerzas Áereas / RCC de Canarias, of Spanish Air Force. OBJECTIVE: The objective is to apply the risk management to medical devices according to UNE-EN ISO 14971: 2012 in a work environment corresponding to a nurse position working in a search and rescue helicopter of the Spanish Air Force. Closely related, the analysis of the risk management board made to the medical devices, and checking compliance with the current legislation relating to the medical device in the work position specified. MATERIALS AND METHODS: It is a descriptive, retrospective and transversal study based on the observation. Recording on computer (Excel) of FMEA method. The area is the population of the Canary Islands, with a population of 2,118,679 inhabitants and an area of 7,447 square kilometers. The analyzed teams are usually shipped as helicopters endowment service, and technical information for each medical device has been directly obtained from the manufacturer's website. RESULTS: We analyzed a total of 13 medical devices. First, doing a description of processes and activities. Then, a policy analysis equipment (verifying that every product ensures the essential requirements set out in Annex I of Royal Decree 1591/2009, of 16 October, by which medical devices are regulated), and finally, an analysis of health risk management is carried out following the FMEA method. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: All the tested products have the CE conformity mark .Therefore, they ensure the essential requirements of the regulations. Finally, some recommendations about operation are added.
INTRODUCTION: In this Thesis, it has been anylised the risk management of medical devices shipped and capable of use by the crew of a search and rescue helicopter belonging to 802 Escuadrón de Fuerzas Áereas / RCC de Canarias, of Spanish Air Force. OBJECTIVE: The objective is to apply the risk management to medical devices according to UNE-EN ISO 14971: 2012 in a work environment corresponding to a nurse position working in a search and rescue helicopter of the Spanish Air Force. Closely related, the analysis of the risk management board made to the medical devices, and checking compliance with the current legislation relating to the medical device in the work position specified. MATERIALS AND METHODS: It is a descriptive, retrospective and transversal study based on the observation. Recording on computer (Excel) of FMEA method. The area is the population of the Canary Islands, with a population of 2,118,679 inhabitants and an area of 7,447 square kilometers. The analyzed teams are usually shipped as helicopters endowment service, and technical information for each medical device has been directly obtained from the manufacturer's website. RESULTS: We analyzed a total of 13 medical devices. First, doing a description of processes and activities. Then, a policy analysis equipment (verifying that every product ensures the essential requirements set out in Annex I of Royal Decree 1591/2009, of 16 October, by which medical devices are regulated), and finally, an analysis of health risk management is carried out following the FMEA method. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: All the tested products have the CE conformity mark .Therefore, they ensure the essential requirements of the regulations. Finally, some recommendations about operation are added.
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Gestión de riesgos, Productos sanitarios, SAR, AMFE