隨著科技的進步帶動了醫療器材的發展，醫療器材技術創新的同時，由於醫療器材使用錯誤所引起的傷害事件，也逐漸受到重視，如何確保和改善醫療設備的安全性和可靠性變得重要。許多醫療器材公司在於設計開發過程中未進行適當的人為可靠度評估，由於對人、環境、組織等因素考慮的不足，導致了不少人為錯誤的問題，因此，組織如何透過人為可靠度評估讓開發人員充分了解用戶安全是刻不容緩之議題。本研究由文獻中彙整人為因素相關資訊，並設計成半結構式訪談大綱，再以內容分析法與業界專家進行訪談，萃取出重要及適合於人為可靠度評估的準則。再將文獻與訪談彙整之準則設計成問卷，並使用決策試驗與實驗評估法(DEMATEL)，建構(發生)頻率程度與(影響)衝擊程度之頻率衝擊分析(Frequency-Impact analysis, FIA)，將透過網路關聯圖(Network Relation Map, NRM)分析來找出人為可靠度評估之因素間之相互影響關係，透過頻率衝擊分析與網路關聯圖分析(FIA-NRM)擬訂有效的人為可靠度評估之改善路徑，依據改善路徑之結果來擬定構面與因素之間的改善策略與執行順序。醫療器材公司可於初期產品設計開發過程即導入本研究之人為可靠度評估模式，以降低器材使用風險，提昇產品的可用性。

Medical devices are flourishing thanks to the advances in technology and science. Meanwhile, the injuries caused by misusing the medical equipment have gradually received attention. How to ensure and improve the safety and reliability of medical devices become important. Many medical equipment companies do not perform appropriate human reliability assessments during the products design process. Owing to the lack of consideration to the factors such as user, environment, organization, etc., many human errors have occurred. Therefore, how to make organizations fully understand the user security through human reliability assessments is an urgent issue. This study collects information of human factors from the literature and we organized them into a semi-structured interview outline. Next, we interviewed some industrial experts by content analysis method to extract important and appropriate criteria for human reliability assessment. The criteria from the literature and interviews are then designed to be questionnaires, and the Decision Making Trial and Evaluation Laboratory methods (DEMATEL) are used to construct (frequency) impact analysis (Frequency-Impact analysis, FIA) and Network relationship map (NRM) analysis. It will be used to find out the interrelationship between factors of human reliability assessment. We can develop improved pathways for human reliability assessment through frequency-impact analysis and Network Relationship Map analysis (FIA-NRM). Based on the results of the improved pathways, the improved strategies and process orders between the dimensions and factors were built. The medical device company can adopt the human reliability assessment model of this research to the initial product design and development process in order to reduce the risk of use from the equipment and improve the product’s usability.

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