Examinando por Materia "Legislación de Dispositivos Médicos"

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Acceso abierto
Cumplimiento de la normativa del Decreto Supremo N.° 016-2011 S.A y modificatorias en el internamiento de los dispositivos médicos en sala de operaciones de la Clínica Stella Maris, periodo agosto–diciembre del 2017
(Universidad Privada Norbert Wiener, 2018-05-25) Flores Malla, Juan Patrik; Poma Huamaní, Ingrid Tiffany; Segura Vílchez, Tito Magno
The objective of this thesis was to identify and evaluate deficiencies in compliance with Regulation D.S. N°016-2011 and its modifications regarding medical devices during the material admission process in the operating room of the Clínica Stella Maris from August to December 2017. The study observed that, at the time of admission, many devices lacked their respective Analysis Protocol and some showed no Sanitary Registration, potentially affecting the health and well-being of the patient and the personnel assisting in the medical-surgical procedure. The study is theoretical, prospective, transversal, and descriptive. The D.S. N°016-2011 S.A. and its modifications were used for this study. To create the data collection forms, consideration was given to every general aspect that medical devices must comply with in their primary or secondary packaging, as stipulated in Articles 124, 125, 126, and 127 of the aforementioned regulation.
Acceso 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.
Acceso abierto
Implementación y certificación de las buenas prácticas de almacenamiento de dispositivos médicos según la norma R.M. N° 132-2015/MINSA en una droguería de San Juan de Lurigancho, 2024
(Universidad Privada Norbert Wiener, 2025-06-23) Ruiz Saucedo, Yober; Ciquero Cruzado, Mélida Mercedes
The implementation of Good Storage Practices (GSP) according to R.M N° 132 2015/MINSA is key to guarantee the quality and safety of medical devices. Medical products, drugs and other derived elements include a wide variety of elements of great importance for the medical area, and require proper care and storage to prevent contamination and detriment to them. General objective: To implement and obtain certification of good storage practices for medical devices according to R.M. N° 132-2015/MINSA in a drugstore in San Juan de Lurigancho, 2024. An observation guide structure instrument entitled “Inspection guide for laboratories, Drugstores, Specialized Warehouses and Customs Warehouses that store pharmaceuticals, medical devices and health products” issued by MINSA, and a checklist were applied. Methodology: This is a quantitative, non-experimental, cross-sectional, applied quantitative study. Results: The implementation of Good Storage Practices in the drugstore located in San Juan de Lurigancho has been largely satisfactory, evidencing compliance with the guidelines established by Ministerial Resolution No. 132-2015/MINSA. Adequate measures have been taken in terms of quality assurance, infrastructure, personnel management, documentation and warehouse conditions. Conclusions: The implementation of Good Practices for the Storage of Medical Devices, in accordance with Royal Decree No. 132-2015/MINSA, was effective, significantly improving the level of compliance.