Improving the accuracy and efficiency of medical devices in the legal metrology system of Bosnia and Herzegovina

Abstract This chapter will show the extent to which the introduction of medical devices into legal metrology has affected the accuracy and effectiveness of 10 medical devices. Medical devices that are introduced into the legal metrology system of Bosnia and Herzegovina, as of 2015 are: ECG, defibrillator, patient monitor, infusion pumps, perfusors, respirators, anesthesia machines, dialysis machines, neonatal and pediatric incubators, and therapeutic ultrasound. It is extremely important that medical devices work properly and precisely, because analysis, interpretations, prints, and reports are formed from these basic measurements through data processing and calculation, based on which doctors draw conclusions, diagnose, and determine the course of treatment. The development of medical devices is an extremely complex process and is subject to a large number of directives, standards, and recommendations that the device must meet in terms of functionality and, in particular, safety, depending on the purpose of the device. This chapter outlines the role of inspection of medical devices to increase accuracy and efficiency in Bosnia and Herzegovina over a period of 3 years. The analysis is based on data collected in the territory of Bosnia and Herzegovina during the period of January 1, 2015 until December 31, 2017. This was collected through an online software to monitor the status of inspection of legal benchmarks in health care. In this analysis, the quality of the work of nine medical devices (infusion pumps and perfusors are viewed together) was measured over a period of 3 years (2015–17) in order to determine the efficiency of the device by monitoring the number of accurate or faulty devices individually and for all devices together. The data are collected in an Excel file and statistical analyses are made in that file. In the inferential statistical analysis, conclusions regarding the differences were made at the usual level of significance of 0.05, that is, a confidence level of 95%.