改良式FMEA應用於醫療器材設計階段之潛在失效風險評估

An Application of Modified FMEA to the Evaluation of Potential Failure Risk in the Design Phase of a Medical Device

10.6220/joq.2014.21(1).02

任恆毅(Hen-Yi Jen)；吳易霖(Yi-Lin Wu)；余佳憓(Chia-Hui Yu)

風險分析 ； 醫療器材 ； Risk Analysis ； FMEA ； Medical Device ； ANP

品質學報

21卷1期（2014 / 02 / 01）

17 - 32

繁體中文

現今年齡人口及家庭結構主軸的轉變，且醫療科技的日益發達，使得老年人壽命得以延長。以臺灣為例，在2019年老人人口占總人口比例將快速提高到14.4%，變成高齡化國家。鑑於國內老人人口快速成長，對於照護需求日益劇增，高品質醫療服務與高品質的醫療器材需求也隨之增加。由於醫療器材涉及人身安全，因此各國政府及相關法規，如ISO13485對於設計與製造醫療器材時需進行風險分析或管理，並判定危害與估計風險。此外ISO14971法規中亦說明風險分析的方法會依實際的需求而有所差別，而失效模式與效應分析（Failure Mode and Effects Analysis，FMEA）則是判定危害與估計風險的重要方法之一。傳統FMEA的執行過程，較少考量風險因子間的相互影響與差異性，可能造成決策者的疏忽或誤判，本研究納入因子間關聯性的建構，以提高對FMEA考量評估因子間可能會相互影響性的「依存關係」與影響自我本身的「回饋效應」的嚴謹程度，並藉由衡量因子間網絡關係，產生特定準則及效率的模式，使決策者於後續執行風險控制措施時，可更客觀決定控制措施或優先處理順序。本研究結果顯示透過改良式FMEA可顯示上下階因子的連動性，並可運用改良式FMEA門檻值來判斷風險程度，來彌補FMEA因RPN同分項目不易判別風險差異的困擾，進而更真實地反應實際的風險狀況。

Nowadays, with the changing landscape of the population, the family structure and the advancement of medical care technology, the average life expectancy keeps lengthening. The elder population ratio in Taiwan is forecasted to grow in a fast path to 14.4% in 2019. This growing trend of more aged population indicates the needs of elder care as well as the demands of high quality medical devices. Medical device has direct impact on human safety and therefore, the risk analysis and mitigation on the design and production of medical devices are highly regulated by the governments around the world. Two international standards: ISO 13485 and ISO 14971 indicate respectively the requirement of risk analysis for medical device manufacturer and how the risk analysis is implemented. Failure Mode Effect Analysis (FMEA) is one of the risk analysis tools to analyze the dangers and risks. However, traditional FMEA assumes independence among risk factors which can lead to negligence and misjudgment by the analyzer. This study applies a modified FMEA method that considers dependent factors. The relative effects of the risk factors among factors (effects) or itself (feedback) can then be analyzed, allowing the analyzer to perform risk control procedures, to decide what activities to perform or prioritize more effectively to increase the quality and reliability of the medical device. In the study, the modified FMEA is implemented in the design phase of a medical device, the results shows clear dependence of risk factors. The proposed threshold value is used to differentiate the risk factors if their RPN numbers are equal, and it gives a more realistic evaluation of risk factors.

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