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This study analyzesthe availability, accessibility, and structure of public information on adverseevents and field safety actions related to critical medical devices,particularly mechanical ventilators. The Mercado Común del Sur (MERCOSUR) promotes the economic, political, and social integration of its member countries through the harmonization of technical regulations, including those applicable to medical products. Post-Market Surveillance (PMS) monitors the performance of devices under real-world conditions, especially within healthcare institutions where clinical engineering departments report failures. A documentary review was conducted on the current regulatory frameworks in Argentina and Brazil, along with an analysis of the official technovigilance platforms managed by ANMAT and ANVISA. The evaluation considered the usefulness of these tools from the perspective of clinical engineering. In Brazil, ANVISA provides aggregated statistical data on adverse events through public dashboards, enabling the identification of trends, field action, and associated records. In Argentina, ANMAT offers access to product registries and official alerts, and oversees post-market surveillance through the digital platforms Helena and Argos. The targeted search for information on ventilators revealed differences in structure and level of detail between both systems. It is concluded that, although both agencies have developed relevant mechanisms for post-market surveillance, limitations persist regarding traceability, search filters, and operational data access. Therefore, improvements are suggested in the availability of structured information, the implementation of unique device identifiers, and the inclusion of clinical staff in reporting system to strengthen risk management within hospital settings.

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Adverse Events and Field Safety Reports of Medical Devices: A Local Review of Ventilators

  • 会议论文

  • 发表日期：

    2025年

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  • Nazarena Emilce Romero,
  • Florencia Sofía Gettig,
  • Sheila Gabriela Riffel,
  • Sergio Osvaldo Escobar,
  • Claudia Edith Bonell,
  • Diego Omar Kadur El Ainie

摘要

This study analyzesthe availability, accessibility, and structure of public information on adverseevents and field safety actions related to critical medical devices,particularly mechanical ventilators. The Mercado Común del Sur (MERCOSUR) promotes the economic, political, and social integration of its member countries through the harmonization of technical regulations, including those applicable to medical products. Post-Market Surveillance (PMS) monitors the performance of devices under real-world conditions, especially within healthcare institutions where clinical engineering departments report failures. A documentary review was conducted on the current regulatory frameworks in Argentina and Brazil, along with an analysis of the official technovigilance platforms managed by ANMAT and ANVISA. The evaluation considered the usefulness of these tools from the perspective of clinical engineering. In Brazil, ANVISA provides aggregated statistical data on adverse events through public dashboards, enabling the identification of trends, field action, and associated records. In Argentina, ANMAT offers access to product registries and official alerts, and oversees post-market surveillance through the digital platforms Helena and Argos. The targeted search for information on ventilators revealed differences in structure and level of detail between both systems. It is concluded that, although both agencies have developed relevant mechanisms for post-market surveillance, limitations persist regarding traceability, search filters, and operational data access. Therefore, improvements are suggested in the availability of structured information, the implementation of unique device identifiers, and the inclusion of clinical staff in reporting system to strengthen risk management within hospital settings.