Abstract

This paper presents the results of safety and performance inspection conducted on 325 infusion pumps in the period from January 2015 to January 2016 in public and private healthcare institutions in Bosnia and Herzegovina. Electrical safety inspection was conducted according to IEC 60601 - Medical electrical equipment: General requirements for basic safety and essential performance of medical devices. Periodical performance inspections were conducted according to legal metrology framework, more specifically according to Rules on metrological and technical requirements for infusion pumps, published in Official Gazette of Bosnia and Herzegovina (BH) No. 75/14. Our results show that approximately 9% of all tested infusion pumps do not meet electrical safety requirements or have performance outside the specifications. The causes of such faulty performance are environmental conditions, long period of usage of devices, faulty motors and device casing, as well as lack of systematic maintenance and regular safety and performance inspections in previous period.

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