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Proposta de Validação e Melhoria da Manutenção Preventiva de Equipamentos Médicos
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| 5.08 MB | Adobe PDF |
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Advisor(s)
Abstract(s)
A manutenção preventiva de equipamentos médicos assume um papel determinante na
segurança dos pacientes e na fiabilidade dos serviços de saúde. No entanto, a ausência de
procedimentos de validação metrológica e funcional compromete frequentemente a eficácia dos
planos de manutenção, permitindo a utilização de dispositivos que, embora operacionais, podem
apresentar desvios nos parâmetros críticos de desempenho. Esta dissertação propõe uma
metodologia integrada de manutenção e validação aplicada a equipamentos utilizados em
Medicina Física e de Reabilitação e em monitorização fetal, recorrendo a soluções experimentais
simples, económicas e tecnicamente fundamentadas.
Foram selecionados dois equipamentos representativos: um aparelho de ultrassons
terapêuticos (Sonopuls 434) e um cardiotocógrafo (Edan F9). Para ambos foram concebidas
montagens experimentais que permitiram avaliar a correspondência entre os valores nominais e
os medidos, recorrendo a análise de incerteza e a princípios de rastreabilidade metrológica. Os
resultados demonstraram que os equipamentos mantêm desempenho clínico aceitável,
apresentando desvios reduzidos relativamente às especificações de fabrico.
A metodologia proposta mostrou-se eficaz, reprodutível e compatível com a realidade
hospitalar, constituindo um contributo relevante para a melhoria dos planos de manutenção
preventiva. A integração de validações metrológicas em contexto clínico permite reforçar a
fiabilidade técnica dos equipamentos, aumentar a segurança do paciente e alinhar as práticas
hospitalares com os requisitos normativos internacionais, nomeadamente o Regulamento (UE)
2017/745, a norma IEC 62353 e a ISO 13485.
Preventive maintenance of medical devices plays a crucial role in ensuring patient safety and the reliability of healthcare services. However, the absence of systematic metrological and functional validation often compromises the effectiveness of maintenance plans, allowing devices to operate with undetected deviations in critical performance parameters. This dissertation proposes an integrated methodology combining maintenance and validation processes applied to equipment used in Physical Medicine and Rehabilitation and fetal monitoring, using simple, costeffective, and technically sound experimental solutions. Two representative devices were selected: a therapeutic ultrasound unit (Sonopuls 434) and a cardiotocograph (Edan F9). For each, an experimental setup was designed to assess the correspondence between nominal and measured values, supported by uncertainty analysis and metrological traceability principles. The results indicated that both devices remained clinically reliable, showing small deviations from manufacturer specifications. The proposed methodology proved to be effective, reproducible, and compatible with hospital environments, representing a valuable contribution to the improvement of preventive maintenance plans. Incorporating metrological validation into clinical practice strengthens the technical reliability of medical equipment, enhances patient safety, and aligns hospital maintenance strategies with international regulatory requirements such as Regulation (EU) 2017/745, IEC 62353, and ISO 13485.
Preventive maintenance of medical devices plays a crucial role in ensuring patient safety and the reliability of healthcare services. However, the absence of systematic metrological and functional validation often compromises the effectiveness of maintenance plans, allowing devices to operate with undetected deviations in critical performance parameters. This dissertation proposes an integrated methodology combining maintenance and validation processes applied to equipment used in Physical Medicine and Rehabilitation and fetal monitoring, using simple, costeffective, and technically sound experimental solutions. Two representative devices were selected: a therapeutic ultrasound unit (Sonopuls 434) and a cardiotocograph (Edan F9). For each, an experimental setup was designed to assess the correspondence between nominal and measured values, supported by uncertainty analysis and metrological traceability principles. The results indicated that both devices remained clinically reliable, showing small deviations from manufacturer specifications. The proposed methodology proved to be effective, reproducible, and compatible with hospital environments, representing a valuable contribution to the improvement of preventive maintenance plans. Incorporating metrological validation into clinical practice strengthens the technical reliability of medical equipment, enhances patient safety, and aligns hospital maintenance strategies with international regulatory requirements such as Regulation (EU) 2017/745, IEC 62353, and ISO 13485.
Description
Keywords
Preventive Maintenance Ultrasound Equipment Cardiotocograph Physical and Rehabilitation Medicine Fetal Heart Rate Manutenção Preventiva Equipamento de Ultrassons Cardiotocógrafo Medicina Física e de Reabilitação