As globally distributed products, intensive-care mechanical ventilators share similar technologies and indications for use. This similarity also extends to possible postmarket occurrences, including mechanical, software, environmental, or usability problems. However, these occurrences can be more effectively shared and addressed by adopting a standardized nomenclature, such as the Global Medical Devices Nomenclature (GMDN), leading to improved patient safety and more efficient regulatory processes. In this work, we discuss different parametrization methods and classification of mechanical ventilators, emphasizing the GMDN. Also, we propose an implementation of GMDN Terms for mechanical ventilators by the Brazilian Health Regulatory Agency (Anvisa). Finally, we discuss the importance of adopting GMDN Terms on the research database Embase to explore the scientific production of medical devices.

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Implementation of a Nomenclature for Intensive-Care Mechanical Ventilators: Spotlighting the GMDN Classification System

  • Cristina Quemelo Adami Fais,
  • H. T. Moriya

摘要

As globally distributed products, intensive-care mechanical ventilators share similar technologies and indications for use. This similarity also extends to possible postmarket occurrences, including mechanical, software, environmental, or usability problems. However, these occurrences can be more effectively shared and addressed by adopting a standardized nomenclature, such as the Global Medical Devices Nomenclature (GMDN), leading to improved patient safety and more efficient regulatory processes. In this work, we discuss different parametrization methods and classification of mechanical ventilators, emphasizing the GMDN. Also, we propose an implementation of GMDN Terms for mechanical ventilators by the Brazilian Health Regulatory Agency (Anvisa). Finally, we discuss the importance of adopting GMDN Terms on the research database Embase to explore the scientific production of medical devices.