Practical principles for reducing risks arising from measurement parameters in equipment operation (on the example of an artificial lung ventilation apparatus)

Abstract

The purpose of this study is to analyze the risks associated with the key clinical parameters of an artificial lung ventilation (ALV) device—tidal volume (VT), respiratory rate (RR), positive end-expiratory pressure (PEEP), peak inspiratory pressure (PIP), and fraction of inspired oxygen (FiO2)—using digital technologies, the HFMEA methodology, and GOST ISO 14971:2021, and to integrate the results into the equipment’s technical condition index. Risk identification, assessment, control, and residual risk monitoring were performed according to the NCPS HFMEA approach. The initial assessment showed that 65.5% of the analyzed parameters were classified as high risk. After implementing control measures, VT and PIP were reduced to low risk, RR and PEEP to medium risk, while FiO2 remained at high residual risk. Consequently, the proportion of high-risk parameters decreased from 65.5% to 32.5%, and the maximum risk score was reduced from 12 to 8 points. Integrating HFMEA results into the technical condition index enables quantitative assessment of ventilator safety.