Spahić Lemana, Sredović Una, Kurpejović Zijad, Mrdanović Emina, Pokvić Gurbeta, Badnjević Almir
Research Institute Verlab for Biomedical Engineering, Medical Devices and Artificial Intelligence, Sarajevo, Bosnia and Herzegovina.
Research and Development Center for Bioengineering BioIRC, Kragujevac, Serbia.
Technol Health Care. 2025 Jul;33(4):2034-2040. doi: 10.1177/09287329241292168. Epub 2025 Mar 3.
BackgroundPoorly 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. As infant incubators are used as a form of fundamental healthcare support for the most sensitive population, prematurely born infants, special care mus be taken to ensure their proper functioning. This is done through a standardized process of post-market surveillance.ObjectiveTo address the issue of faulty infant incubators being undetected and used between yearly post-market surveillance, an automated system based on machine learning was developed for prediction of infant incubator performance status.MethodsIn total, 1997 samples were collected during the inspection process of infant incubator inspections performed by an ISO 17020 accredited laboratory at various healthcare institutions in Bosnia and Herzegovina. Various machine learning algorithms were considered, including Decision Tree (DT), Random Forest (RF), Naïve Bayes (NB) and Logistic Regression (LR) for the development of the automated system.ResultsThe aforementioned algorithms were selected because of their ability to handle large datasets and their potential for achieving high prediction accuracy. The 0.93 AUC of Naïve Bayes indicates that it is overall stronger in predictive capabilities than decision tree and random forest which displayed superior accuracy in comparison to Naïve Bayes.ConclusionThe results of this study demonstrate that machine learning algorithms can be effectively used to predict infant incubator performance status on the basis of measurements taken during post-market surveillance. Adoption of these automated systems based on artificial intelligence will help in overcoming challenges of ensuring quality of infant incubators that are already being used in healthcare institutions.
背景
监管不力且维护不足的医疗设备在安全和性能参数方面存在高风险,会影响患者诊断和治疗的临床效果及效率。由于婴儿培养箱是为最脆弱人群(早产儿)提供的一种基本医疗支持形式,因此必须格外小心以确保其正常运行。这是通过标准化的上市后监测流程来实现的。
目的
为了解决每年上市后监测期间未检测到故障婴儿培养箱并仍在使用的问题,开发了一种基于机器学习的自动化系统来预测婴儿培养箱的性能状态。
方法
在波斯尼亚和黑塞哥维那各医疗机构由一家获得ISO 17020认可的实验室进行的婴儿培养箱检查过程中,总共收集了1997个样本。考虑了各种机器学习算法,包括决策树(DT)、随机森林(RF)、朴素贝叶斯(NB)和逻辑回归(LR)来开发自动化系统。
结果
选择上述算法是因为它们能够处理大型数据集以及具有实现高预测准确性的潜力。朴素贝叶斯的0.93 AUC表明其总体预测能力比决策树和随机森林更强,而决策树和随机森林与朴素贝叶斯相比显示出更高的准确性。
结论
本研究结果表明,机器学习算法可根据上市后监测期间进行的测量有效地用于预测婴儿培养箱的性能状态。采用这些基于人工智能的自动化系统将有助于克服确保医疗机构中已在使用的婴儿培养箱质量方面的挑战。