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In Perú, suspected adverse incidents related to biomedical equipment are underreported and current regulatory systems lacks of an identification and categorization tools. This study proposes a screening and classification system for potential SIAMD (Suspected Incidents of Adverse Medical Devices), based on the content of Maintenance Work Orders (OTM) from a high-complexity health care facility. The objective is to provide health and technical personnel with a practical resource to recognize such events, understand their causes and anticipate their consequences. The analysis of DIGEMID’s quality control records from 2016 to 2024 revealed a 20.3% increase in quality control activity during 2023–2024 compared to 2020–2023, although no quality controls were reported for biomedical equipment over the last eight years. Among the 100 OTM reviewed, 83 were classified as potential SIAMD, primarily involving mechanical ventilators, anesthesia machines and vital signs monitors, mostly due to measurement errors, user-related issues and component failures.

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From Maintenance Records to Risk Detection: A Screening and Classification Framework for Suspected Adverse Incidents in Biomedical Equipments —Case Analysis in High-Complexity Health Care Facility in Lima, Perú

  • 会议论文

  • 发表日期：

    2025年

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  • Harold A. Angeles Gavidia,
  • Sandra M. Pérez-Buitrago

摘要

In Perú, suspected adverse incidents related to biomedical equipment are underreported and current regulatory systems lacks of an identification and categorization tools. This study proposes a screening and classification system for potential SIAMD (Suspected Incidents of Adverse Medical Devices), based on the content of Maintenance Work Orders (OTM) from a high-complexity health care facility. The objective is to provide health and technical personnel with a practical resource to recognize such events, understand their causes and anticipate their consequences. The analysis of DIGEMID’s quality control records from 2016 to 2024 revealed a 20.3% increase in quality control activity during 2023–2024 compared to 2020–2023, although no quality controls were reported for biomedical equipment over the last eight years. Among the 100 OTM reviewed, 83 were classified as potential SIAMD, primarily involving mechanical ventilators, anesthesia machines and vital signs monitors, mostly due to measurement errors, user-related issues and component failures.