Examinando por Autor "Chuquilín Ramírez, Luz del Carmen"
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Publicación Acceso abierto Características de los eventos relacionados al uso de dispositivos médicos en el hospital Nacional Guillermo Almenara Irigoyen, Lima 2021(Universidad Privada Norbert Wiener, 2022-03-30) Chuquilín Ramírez, Luz del Carmen; Caldas Herrera, EmmaTo achieve health-related objectives in relation to medical care and improving the quality of life of patients, medical devices are considered an indispensable element in the prevention, diagnosis and treatment of pathologies. In this context, it is essential to take into account the risks that technology entails in the post-marketing of these products, since these devices can cause serious injuries or death to the patient if not addressed appropriately. (1) According to the WHO, in the United States, approximately one million "adverse events due to medical devices" are reported each year, which is worrying because they could be fatal. Its objective is to reduce the number of injuries, illnesses and deaths caused by medical devices, it established strategic links with health leaders worldwide to address the existing problem. (2) In addition, the WHO states that the accessibility and optimal use of medical devices is one of the concerns raised within the Millennium Development Goals. Due to the wide range of devices, problems related to quality, failure in labeling / manufacturing, inadequate modifications, poor assembly, incorrect use, erroneous selection of usage parameters, accidental spills, wrong connections, environmental factors, electromagnetic interference, loss of power supply, inappropriate technical specifications prior to purchase, inadequate storage, lack of training, lack of policy in hospitals, among others, are frequently found. (4) Several published articles show that the main causes of adverse events are: non-compliance with the regulations established in the context of technovigilance, lack of knowledge and inappropriate use of health technology. In the current context of the pandemic, there is greater concern because medical resources are scarce, which impacts the need to expedite interventions, reports, notifications and there may be greater characterization of these events, which represent a high impact on both economic and social aspects that affect security; constituting an adverse event that can be prevented. (5) (6). These findings warrant increased research and studies that demonstrate the application of technovigilance programs, which are extremely necessary to demonstrate compliance with current regulations regarding user training, quality, safety, performance and efficiency of products, and which in turn contribute to reducing the occurrence of adverse events. The Guillermo Almenara Irigoyen Hospital is a category III-2 health care institution, it has been serving insured personnel for more than 80 years, it is large and receives patients Referrals from Lima Centro, Lima Este, and Lima Norte, which is why the flow of patients treated is quite high. In this sense, the likelihood of various events related to medical devices is also high, which is why the decision was made to conduct the investigation at this institution.
