Failure management and analysis of medical devices

Basit Öğe Kaydı
dc.authorid0009-0000-6542-9295
dc.authorid0000-0002-8039-4147
dc.contributor.authorSalman, Farahen_US
dc.contributor.authorÇepni, Seldenen_US
dc.date.accessioned2025-11-21T06:36:56Z
dc.date.available2025-11-21T06:36:56Z
dc.date.issued2025-11-15
dc.departmentIşık Üniversitesi, Mühendislik ve Doğa Bilimleri Fakültesi, Biyomedikal Mühendisliği Bölümüen_US
dc.departmentIşık University, Faculty of Engineering and Natural Sciences, Department of Biomedical Engineeringen_US
dc.description.abstractMedical device failure management is essential for upholding patient safety and healthcare quality standards. However, existing approaches to analyzing and classifying recalls often lack precision, obstructing the identification of root causes and the implementation of effective mitigation strategies. This study proposes a flowchart to enhance the analysis and classification of medical device recalls, with a specific emphasis on addressing software-related failures. The primary aim is to gather extensive data from the Food and Drug Administration's recall database, encompassing various attributes such as device specifications, recall reasons, severity levels, and manufacturer details. By combining manual review processes with advanced classification techniques, the project aims to develop a vigorous and scalable approach to recall classification. The accuracy and reliability of these techniques will undergo rigorous evaluation, contributing to advancements in recall management practices and regulatory oversight. Through this combined approach, the flowchart ensures that the device undergoes thorough evaluation and risk mitigation measures, thereby minimizing potential risks to patient safety and regulatory compliance. Outcomes include the establishment of an accurate integrated flowchart that enhances the understanding of device safety, facilitates proactive risk mitigation strategies, and improves regulatory compliance. Additionally, study findings will inform the development of engineering standards, quality control processes, and ethical guidelines within the medical device industry, ultimately leading to improved patient safety, environmental sustainability, and economic benefits.en_US
dc.description.versionPublisher's Versionen_US
dc.identifier.citationSalman, F. & Çepni, S. (2025). Failure management and analysis of medical devices. Black Sea Journal of Engineering and Science, 8(6), 1824-1830. doi:https://doi.org/10.34248/bsengineering.1685195en_US
dc.identifier.doi10.34248/bsengineering.1685195
dc.identifier.endpage1830
dc.identifier.issn2619 – 8991
dc.identifier.issue6
dc.identifier.startpage1824
dc.identifier.trdizinid1359467
dc.identifier.urihttps://hdl.handle.net/11729/6787
dc.identifier.urihttps://doi.org/10.34248/bsengineering.1685195
dc.identifier.urihttps://search.trdizin.gov.tr/tr/yayin/detay/1359467
dc.identifier.volume8
dc.indekslendigikaynakTR-Dizinen_US
dc.indekslendigikaynakSobiaden_US
dc.institutionauthorSalman, Farahen_US
dc.institutionauthorÇepni, Seldenen_US
dc.institutionauthorid0009-0000-6542-9295
dc.institutionauthorid0000-0002-8039-4147
dc.language.isoenen_US
dc.peerreviewedYesen_US
dc.publicationstatusPublisheden_US
dc.publisherKaryay Karadeniz Yayımcılık Ve Organizasyon Ticaret Limited Şirketien_US
dc.relation.ispartofBlack Sea Journal of Engineering and Scienceen_US
dc.relation.publicationcategoryMakale - Ulusal Hakemli Dergi - Öğrencien_US
dc.relation.publicationcategoryMakale - Ulusal Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectClassificationen_US
dc.subjectRecallen_US
dc.subjectSoftware failureen_US
dc.subjectMedical devicesen_US
dc.titleFailure management and analysis of medical devicesen_US
dc.typeArticleen_US
dspace.entity.typePublicationen_US

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