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PMID: 40025922 Published · ppublish English Journal Article

Machine learning for improved medical device management: A focus on infant incubators.

Spahić L, Sredović U, Kurpejović Z, Mrdanović E, Pokvić G, Badnjević A

Abstract

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.

Keywords
artificial intelligence clinical engineering infant incubators medical device performance assessment
MeSH 主题词
Machine Learning Humans Infant, Newborn Incubators, Infant/standards Bayes Theorem Algorithms Product Surveillance, Postmarketing/methods Decision Trees
作者与单位
共 6 位作者,点击展开单位 / ORCID
Spahić Lemana ORCID
Research Institute Verlab for Biomedical Engineering, Medical Devices and Artificial Intelligence, Sarajevo, Bosnia and Herzegovina. | Research and Development Center for Bioengineering BioIRC, Kragujevac, Serbia.
Sredović Una
University of Donja Gorica, Podgorica, Montenegro.
Kurpejović Zijad
University of Donja Gorica, Podgorica, Montenegro.
Mrdanović Emina
Research Institute Verlab for Biomedical Engineering, Medical Devices and Artificial Intelligence, Sarajevo, Bosnia and Herzegovina.
Pokvić Gurbeta
Research Institute Verlab for Biomedical Engineering, Medical Devices and Artificial Intelligence, Sarajevo, Bosnia and Herzegovina. | University of Donja Gorica, Podgorica, Montenegro.
Badnjević Almir
Faculty of Pharmacy, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.
Article Info
Journal
Technology and health care : official journal of the European Society for Engineering and Medicine
Abbr.
Technol Health Care
ISSN
1878-7401
Published
2025-07-00
电子出版
2025-00-03
页码
2034-2040
Language
English
Country/Region
United States
NLM ID
9314590
勘误 / 撤稿关联
ExpressionOfConcernIn
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