Testing of Anesthesia Machines and Defibrillators in Healthcare Institutions

Abstract

To improve the quality of patient treatment by improving the functionality of medical devices in healthcare institutions. To present the results of the safety and performance inspection of patient-relevant output parameters of anesthesia machines and defibrillators defined by legal metrology. This study covered 130 anesthesia machines and 161 defibrillators used in public and private healthcare institutions, during a period of two years. Testing procedures were carried out according to international standards and legal metrology legislative procedures in Bosnia and Herzegovina. The results show that in 13.84% of tested anesthesia machine and 14.91% of defibrillators device performance is not in accordance with requirements and should either have its results be verified, or the device removed from use or scheduled for corrective maintenance. Research emphasizes importance of independent safety and performance inspections, and gives recommendations for the frequency of inspection based on measurements. Results offer implications for adequacy of preventive and corrective maintenance performed in healthcare institutions. Based on collected data, the first digital electronical database of anesthesia machines and defibrillators used in healthcare institutions in Bosnia and Herzegovina is created. This database is a useful tool for tracking each device's performance over time.

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“…These samples were acquired during annual periodical inspections (2015 2017) of defibrillators in healthcare institutions in Bosnia and Herzegovina according to legal metrology framework for medical devices. [30][31][32][33][34][35][36][37] So, this dataset stored in the developed database [29], consists of measurements taken from the same defibrillator three years in a row (2015-2016-2017), measurements taken from the same defibrillator two years in a row (2016-2017) and measurement taken on a single defibrillator once (either 2015 or 2016 or 2017). Performance measurements were taken by Fluke Biomedical Impulse 7000 DP [30] and electrical safety measurements were taken by Fluke Biomedical ESA 620 [31].…”

“…Measurements of following parameters were taken: (1) mains voltage (live to neutral, neutral to earth, live to earth), (2) protective earth resistance, (3) insulation resistance (normal condition, mains to protective earth), 4 Inspection decision is formed based on safety and performance inspection. [32][33][34][35][36][37][38][39] It can be either positive (device passed inspection) or negative (inspection fail faulty device) [32]. Accurate device means that defibrillator based on safety and performance inspection conforms to all technical and metrological requirements defined in national legislation, international standards and medical device directives/regulations.…”

“…For instance, in Bosnia and Herzegovina these safety and performance inspections are defined through Legal Metrology Framework for Medical Devices. [11][12][13][14] According to this framework, defibrillators are periodically tested by legally appointed, ISO 17020 accredited laboratory. All safety and performance measurements and defibrillator information, such as serial number, type, manufacturer, location is stored in developed database [15].…”

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