Measurement in medicine – Past, present, future
This paper presents the results of study conducted by the Institute of Metrology of Bosnia and Herzegovina (IMBIH) that highlight the necessity of introducing metrology into medicine and defining standard regulations for inspections of medical devices. As it has been previously done for other kinds of devices that are under jurisdiction of the Institute of Metrology of BH, this research provides a foundation for the introduction of medical devices into the legal metrology system with precisely defined units of measurement, their ranges and errors. The study was based upon data collected through three clinical centers, 25 hospitals, 63 health centers and 320 private health institutions in BH over the course of one year. As a result of this study, the medical devices that have been introduced into the legal metrology system in BH include ECG devices, defibrillators, patient monitors, respirators, anesthesia machines, dialysis machines, pediatric and neonatal incubators, therapeutic ultrasounds, infusion pumps and perfusors. Furthermore, standard inspection regulations for the aforementioned medical devices are also defined. Additionally, a national laboratory for the inspection of medical devices was established and it currently operates under the ISO 17020 standard. Keywords : medical device, healthcare system, legislative, standard, metrology