Cost Effectiveness Analysis of Medical Devices in Legal Metrology System

Medical device inspection is crucial in ensuring safety and reliability of devices since they are an essential component of patient diagnosis or treatment. Periodical inspection of safety and performance in medical devices decreases risk of errors and injuries caused by device malfunction. Device assessment, management and maintenance is crucial in any industry, not just the healthcare sector, but specifically for healthcare—the COVID-19 pandemic has shown how inadequate the present maintenance techniques are and highlighted the importance of regular device inspections. As we live in the digital age, and data is becoming a currency, investigating the possibility of using the data to update the current medical device maintenance programs is necessary. In order to optimise the maintenance programs, quantifiable factors and good databases are needed which form a good foundation for evidence-based maintenance of medical devices. Evidence-based methodology for surveillance of medical devices has been part of the legal metrology framework in Bosnia and Herzegovina and in the Republic of Serbia. All data resulting from the inspection carried out by independent appointed inspection bodies have been entered in a database specially developed for this purpose. In countries such as these two (third world countries) it is still necessary to improve the system which would lead to superior use of the medical system in the health system. This chapter will outline the role and the importance of the inspection of medical devices in the health system. The data provided from these countries are used in order to determine the cost effectiveness of medical device inspections. The data and analysis will show how the medical devices have affected its accuracy and effectiveness when they have been introduced into the legal metrology of Bosnia and Herzegovina and Republic of Serbia.