Machine learning for improved medical device management: A focus on defibrillator performance

Background Poorly regulated and insufficiently maintained medical devices (MDs) carry high risk on safety and performance parameters impacting the clinical effectiveness and efficiency of patient diagnosis and treatment. After the MD directive (MDD) had been in force for 25 years, in 2017 the new MD Regulation (MDR) was introduced. One of the more stringent requirement is a need for better control of MD safety and performance post-market surveillance mechanisms. Objective To address this, we have developed an automated system for management of MDs, based on their safety and performance measurement parameters, that use machine learning algorithm as a core of its functioning. Methods In total, 1997 samples were collected during the inspection process of defibrillator inspections performed by an ISO 17020 accredited laboratory at various healthcare institutions in Bosnia and Herzegovina. This paper presents solution developed for defibrillators, but proposed system is scalable to any other type of MDs, both diagnostic and therapeutic. Results Various machine learning algorithms were considered, including Decision Tree (DT), Random Forest (RF), Naïve Bayes (NB) and Logistic Regression (LR). In addition, random forest regressor and XG Boost algorithms were tested for their predictive capabilities in the field of defibrillator output error prediction. These algorithms were selected because of their ability to handle large datasets and their potential for achieving high prediction accuracy. The highest accuracy achieved on this dataset was 94.8% using the Naive Bayes algorithm. The XGBoost Regressor with its r 2 of 0.99 emerged as a powerful tool, showcasing exceptional predictive accuracy and the ability to capture a substantial portion of the dataset's variability. Conclusion The results of this study demonstrate that clinical engineering (CE) and health technology management (HTM) departments in healthcare institutions can benefit from proposed automatization of defibrillator maintenance scheduling in terms of increased safety and treatment of patients, on one side, and cost optimization in MD management departments, on the other side.