Critical importance of multilateral studies related with adverse events in medical devices

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• 作者：Guillermo Avendaño
• 关键词：Iatrogenic ; Adverse events ; Recalls ; Health technology ; Technological surveillance
• 刊名：Health and Technology
• 出版年：2016
• 出版时间：November 2016
• 年：2016
• 卷：6
• 期：3
• 页码：213-227
• 全文大小：
• 刊物主题：Biomedical Engineering; Computational Biology/Bioinformatics; Medicine/Public Health, general; Biomedicine, general; R & D/Technology Policy; Biological and Medical Physics, Biophysics;
• 出版者：Springer Berlin Heidelberg
• ISSN：2190-7196
• 卷排序：6

文摘

Nowadays Health Technology devices are growing up very rapidly; there is no healthcare specialty that does not use technologies of different complexity, this increasing amount of devices, also increases the number of adverse events related to such technologies. This study shows how different nature factors concur in the occurrence of adverse events with iatrogenic results, there are problems related to technological complexity, with the materials used, with quality control in manufacturing, with the software involved, with maintenance procedures and obviously with the way that devices are being operated by healthcare personnel, and in some cases by the same patient if he is connected to the device. It is important, to perform multilateral studies, to detect and avoid factors that generate adverse events. To avoid the risk, measures must be taken into account within a wide range of tasks such as improving product quality, providing an adequate user training and reporting any dangerous event via technological surveillance for information feedback to manufacturers, aimed at improving the production or correcting deficiencies of medical devices. Unfortunately, it is not only necessary to act in the technological and administrative level, it is also necessary to eradicate practices such as the lobby and low transparent policies, on technology acquisition or marketing of products that do not meet all the requirements and regulations that helps to increase the quality services and avoid risks to patients and users.