Testing of dialysis machines in healthcare institutions in Bosnia and Herzegovina

Post-market surveillance of medical devices: A review

“…The fact is that standard ISO 13485:2016 [7] requires manufacturers to maintain a PMS system regardless of how their medical device is classified. However, this approach has its limitations which can be seen through variability of MD performance as reported in studies mentioned above [59][60][61][62][63][64], as well as by the number of reported incidents of the patient injuries and deaths including medical devices [65][66][67]. Given these facts, one can conclude that current status of PMS results in duplication of resources and human effort, lack of strategic coordination, mistrust in medical performance and reliability as well as poor responses to global challenges such as the COVID-19 pandemic which only emphasizes the need for harmonization of MD performance evaluation during PMS.…”

“…According to this legal metrology framework, an independent authorized third body measures MD performance through periodic inspections and the results of inspection are reported in the medical device registry developed for this purpose. Particularly, in Republic of Serbia and Bosnia and Herzegovina independent inspection bodies perform performance evaluation of 12 types of MDs: ECG devices, defibrillators, patient monitors, infant incubators, therapeutic ultrasounds, dialysis machines, anesthesia machines, mechanical ventilators, infusomats, perfusion pumps, high-frequency surgical units and blood pressure devices [59][60][61][62][63]. The results of these inspections are reported in medical device registry [49][50][51] and are used for MD surveillance.…”

“…Gurbeta et al [60] reported that 13.84% of tested anesthesia machines and 14.91% of defibrillators device performance is not in accordance with requirements and should either have the device removed from use or scheduled for corrective maintenance. On the other hand, for dialysis machines [61], the results show that 12.6% of inspected devices do not meet electrical safety requirements or have performance outside the specifications. Specifically, 2% of tested devices did not pass the safety inspection in accordance with IEC 60601.…”

Evidence-based clinical engineering: Machine learning algorithms for prediction of defibrillator performance

“…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.…”