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: | , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Kiban Multidisciplinary Business Management Welfare Society
2024
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| Subjects: | |
| 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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| Summary: | 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. |
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