Legal Metrology Procedures for Increasing Safety and Performance Characteristics with Cost Benefits Analysis: Case Study Dialysis Machines

Evidence-based maintenance of medical devices: Current shortage and pathway towards solution

“…Safety and performance testing of medical devices in the medical sector is one of the key factors in improving public health [28][29][30][31][32][33][34]. Physicians need better accurate medical measurements to diagnose diseases better, monitor patients and deliver treatments.…”

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

“…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].…”