POST-MARKET SURVEILLANCE AND METROLOGICAL ASSESSMENT OF MECHANICAL VENTILATORS: A COMPARATIVE STUDY IN THE BALKAN REGION

Mechanical ventilators play a crucial role in managing patients with various lung conditions, infections, or severe acute respiratory issues. Their role became particularly evident during the COVID-19 pandemic. It is important to highlight that the assessment and verification of mechanical ventilators involve multiple parameters, including: inspiratory flow and time, respiratory rate, oxygen concentration, tidal volume, peak inspiratory pressure, and positive end-expiratory pressure. Furthermore, these devices may manifest diverse defects, such as ventilatory volume failures, issues with oxygen concentration, broken components, and more severe malfunctions like complete circuit board failures.
This study investigates the performance of mechanical ventilators in Bosnia and Herzegovina and the Republic of Serbia during the period from March 2020 to September 2022, and October 2020 to September 2022 respectively. Additionally, the research focuses on identifying the number and type of defects observed in unverified mechanical ventilators within these countries. Having completed the thorough analysis, various volumetric defects were found in mechanical ventilators that were used in Bosnia and Herzegovina which present over 50% of all found defects in unverified devices.
The paper aims to emphasize the need for standardized verifications and protocols that should be fortified to ensure the patients’ safety and the prolongation of device stability and usage.