Medical devices in legal metrology

In addition to knowledge and experience of medical doctors, correct diagnosis and appropriate patient treatment largely depend on accuracy and functionality of medical devices. In a large number of serious medical situations proper functionality of medical devices is crucial for patients. Therefore it is necessary to carry out as strict and independent testing of functionalities of medical devices as possible and to obtain the most accurate and reliable diagnosis and patient treatment. 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. With the introduction of medical devices into the legal metrology system and with the establishment of a fully operational national laboratory for inspection of medical devices, we expect that the reliability of medical devices in diagnosis and patient care will increase and that the costs of the health care system in BH will be reduced.