Proceedings of the 3rd Multidisciplinary International Conference, MIC 2023, 28 October 2023, Jakarta, Indonesia

Research Article

Juridical Review of Medical Devices in Legal Regulation, Hospital Accreditation, and ISO Management System at RSPAD Gatot Soebroto

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  • @INPROCEEDINGS{10.4108/eai.28-10-2023.2341747,
        author={Rineke  Sara and Ramlan  Ramlan},
        title={Juridical Review of Medical Devices in Legal Regulation, Hospital Accreditation, and ISO Management System at RSPAD Gatot Soebroto},
        proceedings={Proceedings of the 3rd Multidisciplinary International Conference, MIC 2023, 28 October 2023, Jakarta, Indonesia},
        publisher={EAI},
        proceedings_a={MIC},
        year={2023},
        month={12},
        keywords={rspad gatot soebroto juridical review medical devices},
        doi={10.4108/eai.28-10-2023.2341747}
    }
    
  • Rineke Sara
    Ramlan Ramlan
    Year: 2023
    Juridical Review of Medical Devices in Legal Regulation, Hospital Accreditation, and ISO Management System at RSPAD Gatot Soebroto
    MIC
    EAI
    DOI: 10.4108/eai.28-10-2023.2341747
Rineke Sara1, Ramlan Ramlan1,*
  • 1: Universitas Borobudur
*Contact email: syukriramlan045@gmail.com

Abstract

The use of medical devices according to standards will improve the quality of health services for the community. Quality health services have implications for improving the quality of life of the community. This study analyzes the feasibility of using medical devices in terms of legal regulations, hospital accreditation and the use of the Domestic Content Level (TKDN). This research uses a qualitative approach with the case study method as a strategy of inquiry. Primary data collection was conducted by in-depth interviews and observations. While secondary data were collected through document studies and analyzed with qualitative data findings intensively. The results of this study show that the use of medical devices in accordance with legal regulations, hospital accreditation and using and paying attention to medical devices with TKDN have implications for quality health services among patients at RSPAD Gatot Subroto hospital.