Elaboración de una base de datos para la identificación de eventos adversos asociados al uso de dispositivos médicos en pacientes hospitalizados en unidad de cuidados intensivos

Abstract

Medical devices are instruments used for the diagnosis of treatments, also for the maintenance of life and modification of physiological processes. They are classified according to the risk, in four different classes, corresponding to low risk (Class I), moderate risk (Class IIa), high risk (Class IIb), high risk (Class III). Which are regulated by various decrees and resolutions by the Ministry of Social Protection, as Resolution 004816 of 2008, Decree 4725 of 2005 and Resolution No. 1403 of 2007. With this study is to create a database that will consult when you are identifying, reporting adverse events associated with medical devices, which are preventable as they are created improvement plans to standardize procedures safer and ensure quality of service, reducing the problems of inappropriate use of the same to strengthen patient safety. For the identification of adverse events, a search was done for information on the technical specifications of medical devices, technical surveillance publications and related items, in order to determine the reported adverse events associated with inappropriate use of medical devices and recognize that faulty procedures depends on the quality of the device and the use to be given. In this project we selected medical devices used in the Intensive Care Unit then will create the data collection instrument, in order to classify the adverse events associated with the use of medical devices in an intensive care unit reported in the literature.