This study focuses on the technical evaluation of electrosurgical units (ESUs), crucial equipment in modern surgical practice. These ESUs replace conventional scalpels, utilizing high-frequency electrical currents to perform tissue cutting or coagulation during surgical procedures. This article provides a detailed description of the procedures conducted to evaluate the safety and performance of ESUs in the University Hospital at the University of São Paulo (HU-USP). The technical evaluation was performed following standards established by the International Electrotechnical Commission (IEC), with emphasis on IEC 62353 and IEC 60601-2-2 norms. Methods, measuring instruments, and acceptance criteria were meticulously defined, ensuring precise and comprehensive evaluation of ESUs. Results revealed the need for the disposal or repair of some units due to significant discrepancies in performance or safety. Furthermore, this study highlights the importance of an ongoing calibration and maintenance program in hospitals to ensure the safe and effective operation of ESUs. Collaboration between the hospital maintenance section and the biomedical engineering laboratory was important for conducting these evaluations. The findings of this study highlight the need for continuous attention to the safety and performance of medical equipment, especially in hospital environments where accuracy and reliability are essential for operator and patient safety. Implementing technical evaluation procedures as described in this study can help identify and address potential issues before they negatively impact clinical results.

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Evaluation of Electrosurgical Units in the Context of Post-market

  • D. A. O. Rosa,
  • Edison Silva Filho,
  • M. R. Nunes,
  • D. M. Nascimento,
  • P. M. Zanuzzio,
  • H. T. Moriya

摘要

This study focuses on the technical evaluation of electrosurgical units (ESUs), crucial equipment in modern surgical practice. These ESUs replace conventional scalpels, utilizing high-frequency electrical currents to perform tissue cutting or coagulation during surgical procedures. This article provides a detailed description of the procedures conducted to evaluate the safety and performance of ESUs in the University Hospital at the University of São Paulo (HU-USP). The technical evaluation was performed following standards established by the International Electrotechnical Commission (IEC), with emphasis on IEC 62353 and IEC 60601-2-2 norms. Methods, measuring instruments, and acceptance criteria were meticulously defined, ensuring precise and comprehensive evaluation of ESUs. Results revealed the need for the disposal or repair of some units due to significant discrepancies in performance or safety. Furthermore, this study highlights the importance of an ongoing calibration and maintenance program in hospitals to ensure the safe and effective operation of ESUs. Collaboration between the hospital maintenance section and the biomedical engineering laboratory was important for conducting these evaluations. The findings of this study highlight the need for continuous attention to the safety and performance of medical equipment, especially in hospital environments where accuracy and reliability are essential for operator and patient safety. Implementing technical evaluation procedures as described in this study can help identify and address potential issues before they negatively impact clinical results.