Browsing by Author "Pérez, María"

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    Quality management in imaging services
    (2025) Ubeda, Carlos; Soffia, Pablo; Inzulza, Alonso; Khoury, Helen; Khoury, Viviane; Wunderlen, Kevin; Donoso, Sigrid; Pérez, María; Franco, María
    In an imaging procedure with ionizing radiation, different elements are involved, and each possible failure in one of them can be associated with a detriment to its quality. The loss of quality has ethical and economic implications, which is why it must be managed intentionally. Therefore, it is recommended to establish a quality management system (QMS), which represents a standard framework for the administration that ensures correct execution and the desired results through compliance with a series of requirements on the different aspects or components of the service. To guarantee the success of a QMS, actions based on quality assurance (QA) and quality control (QC) must be established. When reviewing the Chilean regulations that regulate the use of ionizing radiation in medicine, we found that there is a deficiency in the concepts and applications in the requirements that refer to QMS, QA and QC. The purpose of this narrative review is to present an updated revision for health administrators and professionals on the rationale and purpose of a QMS, and QA and QC as its essential components, in imaging services. En un procedimiento imagenológico con radiaciones ionizantes intervienen diferentes elementos, y a cada posible fallo en alguno de ellos cabe asociar un detrimento en la calidad del mismo. La pérdida de calidad tiene implicancias éticas y económicas, razón por la cual esta debe ser gestionada con intencionalidad. Así, se recomienda establecer un sistema de gestión de la calidad (SGC), que representa un marco estándar para la administración que asegura la correcta ejecución y los resultados deseados mediante el cumplimiento de una serie de requisitos sobre los diferentes aspectos o componentes de la atención. Para garantizar el éxito de un SGC se deben establecer acciones sustentadas en la garantía de calidad (GC) y el control de calidad (CC). Al revisar la normativa chilena que regula el uso de las radiaciones ionizantes en medicina, constatamos que existe un vacío de conceptos y aplicaciones en los requerimientos que hacen referencia a SGC, GC y CC. La presente revisión narrativa tiene como propósito presentar una revisión actualizada para administradores y profesionales de la salud sobre la justificación y el propósito de un SGC, y de la GC y el CC como sus componentes esenciales, en los servicios de imagenología.
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    Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial
    (2022) Abarca, Katia; Iturriaga, Carolina; Urzúa, Marcela; Le Corre, Nicole; Pineda, Augusto; Fernández, Carolina; Domínguez, Angélica; González, Pablo; Bueno, Susan; Donato, Paulina; Espinoza, Pilar; Fuentes, Daniela; González, Marcela; Guzmán, Paula; Muñoz Venturelli, Paula; Pérez, Carlos; Potin, Marcela; Rojas, Álvaro; González, José; Gálvez, Nicolás; Aguirre, Francisca; Aljaro, Sofía; Bátiz, Luis; Campisto, Yessica; Cepeda, Mariela; Cortés, Aarón; López, Sofía; Pérez, María; Schilling, Andrea; Kalergis, Alexis; On behalf of the CoronaVac CL Study Group
    Several vaccines have been developed to control the COVID-19 pandemic. CoronaVac®, an inactivated SARS-CoV-2 vaccine, has demonstrated safety and immunogenicity, preventing severe COVID-19 cases. We investigate the safety and non-inferiority of two immunization schedules of CoronaVac® in a non-inferiority trial in healthy adults. A total of 2302 healthy adults were enrolled at 8 centers in Chile and randomly assigned to two vaccination schedules, receiving two doses with either 14 or 28 days between each. The primary safety and efficacy endpoints were solicited adverse events (AEs) within 7 days of each dose, and comparing the number of cases of SARS-CoV-2 infection 14 days after the second dose between the schedules, respectively. The most frequent local AE was pain at the injection site, which was less frequent in participants aged ≥60 years. Other local AEs were reported in less than 5% of participants. The most frequent systemic AEs were headache, fatigue, and myalgia. Most AEs were mild and transient. There were no significant differences for local and systemic AEs between schedules. A total of 58 COVID-19 cases were confirmed, and all but 2 of them were mild. No differences were observed in the proportion of COVID-19 cases between schedules. CoronaVac® is safe, especially in ≥60-year-old participants. Both schedules protected against COVID-19 hospitalization.

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