Application of Failure Mode and Effects Analysis (FMEA) to Improve Medical Device Reliability

Medication safety is a pressing global concern, highlighting the need for reliable and secure medical devices within the healthcare industry. Device malfunctions can severely affect patient well-being, necessitating effective engineering and maintenance practices to address these risks. This researc...

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Main Authors: F.H.P.A, Dattu, Syed Tarmizi, Syed Shazali, S. J., Tanjong, Abdul Rani Achmed, Abdullah
Format: Article
Language:English
Published: Kiban Multidisciplinary Business Management Welfare Society 2024
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Online Access:http://ir.unimas.my/id/eprint/46706/1/Application%20of%20Failure%20Mode%20and%20Effects%20Analysis%20%28FMEA%29.pdf
http://ir.unimas.my/id/eprint/46706/
https://ijmbm.org/current-issue.html
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spelling my.unimas.ir-467062024-11-25T06:59:28Z http://ir.unimas.my/id/eprint/46706/ Application of Failure Mode and Effects Analysis (FMEA) to Improve Medical Device Reliability F.H.P.A, Dattu Syed Tarmizi, Syed Shazali S. J., Tanjong Abdul Rani Achmed, Abdullah TJ Mechanical engineering and machinery Medication safety is a pressing global concern, highlighting the need for reliable and secure medical devices within the healthcare industry. Device malfunctions can severely affect patient well-being, necessitating effective engineering and maintenance practices to address these risks. This research constitutes a significant advancement in this field by utilizing Failure Modes and Effects Analysis (FMEA) to evaluate and improve the dependability and safety of medical devices. The study prioritizes risks and formulates targeted mitigation strategies by systematically identifying potential failure modes, assessing their consequences, and determining their likelihood of occurrence and detection. The comprehensive FMEA process examines operational conditions and identifies critical areas for enhancement, resulting in substantial improvements in device reliability. The findings emphasize the importance of proactive risk management and continuous improvement in the engineering and maintenance of medical devices. This paper provides a solid foundation for implementing FMEA in engineering and maintaining medical devices, offering valuable insights for manufacturers and regulatory agencies to enhance device safety and performance. Kiban Multidisciplinary Business Management Welfare Society 2024 Article PeerReviewed text en http://ir.unimas.my/id/eprint/46706/1/Application%20of%20Failure%20Mode%20and%20Effects%20Analysis%20%28FMEA%29.pdf F.H.P.A, Dattu and Syed Tarmizi, Syed Shazali and S. J., Tanjong and Abdul Rani Achmed, Abdullah (2024) Application of Failure Mode and Effects Analysis (FMEA) to Improve Medical Device Reliability. International Journal Multidisciplinary Business Management (IJMBM), 12 (6). pp. 24-30. ISSN 2286-8445 https://ijmbm.org/current-issue.html
institution Universiti Malaysia Sarawak
building Centre for Academic Information Services (CAIS)
collection Institutional Repository
continent Asia
country Malaysia
content_provider Universiti Malaysia Sarawak
content_source UNIMAS Institutional Repository
url_provider http://ir.unimas.my/
language English
topic TJ Mechanical engineering and machinery
spellingShingle TJ Mechanical engineering and machinery
F.H.P.A, Dattu
Syed Tarmizi, Syed Shazali
S. J., Tanjong
Abdul Rani Achmed, Abdullah
Application of Failure Mode and Effects Analysis (FMEA) to Improve Medical Device Reliability
description Medication safety is a pressing global concern, highlighting the need for reliable and secure medical devices within the healthcare industry. Device malfunctions can severely affect patient well-being, necessitating effective engineering and maintenance practices to address these risks. This research constitutes a significant advancement in this field by utilizing Failure Modes and Effects Analysis (FMEA) to evaluate and improve the dependability and safety of medical devices. The study prioritizes risks and formulates targeted mitigation strategies by systematically identifying potential failure modes, assessing their consequences, and determining their likelihood of occurrence and detection. The comprehensive FMEA process examines operational conditions and identifies critical areas for enhancement, resulting in substantial improvements in device reliability. The findings emphasize the importance of proactive risk management and continuous improvement in the engineering and maintenance of medical devices. This paper provides a solid foundation for implementing FMEA in engineering and maintaining medical devices, offering valuable insights for manufacturers and regulatory agencies to enhance device safety and performance.
format Article
author F.H.P.A, Dattu
Syed Tarmizi, Syed Shazali
S. J., Tanjong
Abdul Rani Achmed, Abdullah
author_facet F.H.P.A, Dattu
Syed Tarmizi, Syed Shazali
S. J., Tanjong
Abdul Rani Achmed, Abdullah
author_sort F.H.P.A, Dattu
title Application of Failure Mode and Effects Analysis (FMEA) to Improve Medical Device Reliability
title_short Application of Failure Mode and Effects Analysis (FMEA) to Improve Medical Device Reliability
title_full Application of Failure Mode and Effects Analysis (FMEA) to Improve Medical Device Reliability
title_fullStr Application of Failure Mode and Effects Analysis (FMEA) to Improve Medical Device Reliability
title_full_unstemmed Application of Failure Mode and Effects Analysis (FMEA) to Improve Medical Device Reliability
title_sort application of failure mode and effects analysis (fmea) to improve medical device reliability
publisher Kiban Multidisciplinary Business Management Welfare Society
publishDate 2024
url http://ir.unimas.my/id/eprint/46706/1/Application%20of%20Failure%20Mode%20and%20Effects%20Analysis%20%28FMEA%29.pdf
http://ir.unimas.my/id/eprint/46706/
https://ijmbm.org/current-issue.html
_version_ 1817848757247541248
score 13.223943