Examinando por Autor "Béjar Delgado, Giovanni Jefferson"
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Publicación Acceso abierto Analizar los dispositivos médicos rechazados en el centro quirúrgico de la Clínica Vesalio en base a sus principios, normas, criterios y exigencias básicas, de acuerdo al Decreto Supremo N.° 016-2011/SA-2012(Universidad Privada Norbert Wiener, 2013) Béjar Delgado, Giovanni Jefferson; Chunga Guzmán, Josefa Eduviges; Llatas Gonzales, Yvonne MagaliThis research describes the regulatory conditions in Peru, with greater detail regarding medical devices, with the purpose of identifying those that were rejected in the surgical center of Clínica Vesalio, based on their regulations, criteria, and basic requirements, according to Supreme Decree No. 016-2011/SA, during the year 2012. The rejected medical devices were identified through surveys applied to surgeons and scrub nurses. These rejected medical devices were identified in the surgical center of Clínica Vesalio. The most frequent were the adult urine collection bag, with 33.33%; the two-way Foley catheter, with 26.67%; the gauze sponge, with 23.33%; and surgical gloves, with 16.67%. Likewise, the reasons for rejection were identified. The most frequent was poor quality, with 33.33%, followed by fragility (23.33%); packaging that does not ensure adequate sterility (16.66%); non-compliance with shelf life (16.66%); and finally, non-hermetic sealing, with 10%.
