Abstract
In Bosnia and Herzegovina, legal metrology framework has been implemented as a tool for ensuring safety and performance accuracy of medical devices. This paper presents the analysis of results for these periodical inspections of patient monitor. The analysis is based on 2118 patient monitor inspection reports from April 2015–December 2020. Inspections were conducted in clinical centers, hospitals and several primary healthcare institutions using etalon with documented traceability to SI units. The results show that in six-year period of implementation of this metrology-based framework for medical device management and assessment at national level the drop of 5.38% of patient monitor fault rate was achieved. Also, all performance measurements are available through information system which provides comprehensive management of these medical devices at institutional and national level.
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Deumić, A., Imamović, E., Pokvić, L.G., Badnjević, A. (2021). Performance Inspection of Patient Monitors According to the Legal Metrology Framework: Bosnia and Herzegovina Case Study. In: Badnjevic, A., Gurbeta Pokvić, L. (eds) CMBEBIH 2021. CMBEBIH 2021. IFMBE Proceedings, vol 84. Springer, Cham. https://doi.org/10.1007/978-3-030-73909-6_44
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DOI: https://doi.org/10.1007/978-3-030-73909-6_44
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