Examinando por Autor "Llatas Gonzales, Yvonne Magali"

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    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 Magali
    This 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%.
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    PublicaciónAcceso abierto
    Enfoque regulatorio peruano y de las agencias reguladoras de países de alta vigilancia sanitaria de la Unión Europea y América sobre el uso de dispositivos médicos con di (2-etilhexil) ftalato en la población vulnerable
    (Universidad Privada Norbert Wiener, 2018-09-19) Acuña Graciano, Linda Erica; Salvatierra Guerrero, Sandra Sofia; Llatas Gonzales, Yvonne Magali
    This research presents the regulations, management approaches, and official statements of High Health Surveillance Agencies from the European Union and the Americas regarding the use of medical devices containing DEHP. It also examines the fundamental principles and guidelines of Peruvian health regulation related to this issue. In addition, this work compiles considerations on the role of other specialized institutions that provide scientific support for the development of more appropriate regulatory frameworks. For more than 40 years, health regulation was primarily based on granting marketing authorizations for medical devices without validating their safety or assessing their potential impact on vulnerable populations. The future outlook for Peruvian health regulation should be grounded in reforms to the current regulatory framework, taking as a reference an agile, simple, transparent, and effective model, supported by scientific evidence and modern, reliable technical procedures.