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

Abstract

The objective of this paper was to increase safety and performance characteristics with cost benefits of medical devices (MDs) by introducing legal metrology procedures. This should directly improve the quality of patient safety and re-liability of treatment. This study is designed to cover 1100 dialysis machines used in public and private healthcare institutions, during a period of three years. Testing procedures were carried out according to international standards and legal metrology legislative procedures in Bosnia and Herzegovina. The results show that the average rate of faulty devices during three years testing period is 36.33% and should either have its results be verified, or the device removed from use or scheduled for corrective maintenance. Additionally, cost benefits analysis shows yearly savings of 30% if healthcare institutions follow legal metrology procedures compared with unnecessary manufactures attests. Research emphasizes importance of independent safety and performance inspections and gives recommendations for the frequency of inspection based on measurements. Results offer implications for adequacy of preventive and corrective maintenance performed in healthcare institutions. Based on collected measurement data, web-based application with database of dialysis machines used in healthcare institutions in Bosnia and Herzegovina is created. Thus, legal metrology procedures enabled establishing traceability chain for this type of MDs.