Browsing by Autor "Rodrigo Mijares"

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Clinical Engineering and health policies in Venezuela: challenges and achievements in a changing political context
(2023) Rodrigo Mijares
This article summarizes the evolution of clinical engineering in Venezuela and its interaction with the political environment and health policies. Method: The study consists of a comprehensive review of publications from the Health Technologies Management Unit of Simón Bolívar University throughout 1992-2023, organized into three thematic areas: Technological and Environmental; Relationship with Public Health Policies; and Influence of the Political System. Conclusions: The early history of clinical engineering in Venezuela stands out for its impact on training and technological management to ensure quality and efficiency in the Venezuelan healthcare system. In the first area, it demonstrated the potential for improvement in medical technologies, generating high expectations. The second area focuses on the relationship between technologies and health policies, emphasizing the need to align public policies and technological management. However, challenges identified include the lack of evaluation and selection of appropriate medical technologies and political influence in acquisitions. The third area addresses political influence on the quality of medical care, emphasizing the importance of considering political and technological aspects in decision-making.
Quality Certification of Medical Devices in Venezuela: Process Developed by Simón Bolívar University, Caracas-Venezuela
(2020) Rodrigo Mijares; Néstor Utrera; Zhayda Sierra; Sara Montoya González; Rubén Lugo; María Eugenia Rincón; Raquel Mijares
Background and objective: medical devices and supplies increase productivity in health institutions, contributing to the reduction of morbidity and mortality rates. However, the use of medical devices has an associated level of risk. A third party must guarantee the safety and effectiveness of the medical team to grant a quality certification. In Venezuela, one of the institutions authorized by the regulatory entity (Ministry of Popular Power for Health) that grants quality certification is the Health Technology Management Unit (UGTS) attached to the Research and Development Foundation (FUNINDES ) from the Simón Bolívar University (USB). The objective of this work is to show the certification protocol by the UGTS and its results. Material and Methods; It based on the ISO 9001 standard for the processes. Five activities were determined: Prepare the teaching, technical and administrative staff as ISO auditors. Carry out an external audit, in order to make proposals for improvement; Plan changes in our quality management system and processes and Qualify as a supplier guided by the ISO 9001 philosophy by a prestigious international company. Results: Based on the results, general and particular proposals were proposed to improve the process. These were adopted by the group and later in the evaluation of an international company the USB was qualified as an approved supplier for the analysis of medical devices by the company Johnson & Johnson Medical S.C.S. when complying with ISO 9001 Standard. Conclusions: The UGTS is authorized by the Ministry of Popular Power for Health (MPPS) through the Sanitary Comptroller's Office to issue quality certificates to medical teams since 1999. Approximately 55 companies that have received service are registered in its database. In the period audited (2012 - 2014), 25 files were created. Its processes comply with ISO 9001.