國內醫療器材產業近五年來，整體銷售金額以高於9.2%的年複合成長率且持續成長中，而我國醫療器材主要出口對象-美國市場，於過去近10年來整體銷售金額也以年複合成長率9%的速度持續成長中。進一步探討醫療器材市場規模成長原因，其中除了來自既有產品的貢獻之外，有更大一部份是來自於技術創新或產品創新後造成的需求增加。然而，除了市場規模快速成長外，各種創新之下也使醫療器材使用上的複雜度逐漸提高，美國市場上與醫療器材有關之重大醫療異常事件更以高過市場成長率8個百分點的速度持續上升中。雖然多數醫療危害事件主要是因為人為疏失造成，但因器材使用安全問題而引起的危害也不容忽視。因此，本論文以美國市場所有與醫療器材有關的異常事件中，自2005年來因已造成超過18,500件重大醫療異常而居於事件數首位之輸液幫浦為對象，收集美國食品暨藥物管理局之醫療器材召回資料庫，於2005至2011年期間輸液幫浦一級與二級召回事件，並以受世界各國監管機構與醫療器材業界普遍採用的IEC/ISO國際標準規範，進行召回原因的分析與分類，以便能夠找出醫療器材於使用安全上，還有哪些較常被忽略與待改善的問題。

本研究顯示，輸液幫浦召回事件的主要原因為其可能產生對患者健康造成嚴重影響的危險輸出，而造成危險輸出的問題來源包含:(1)零組件、(2)警報系統、(3)使用者行為、(4)人機介面、(5)軟體、(6)隨附文件、(7)環境中的其他因素等七種問題類別。本研究所整理之召回原因、分析與改善建議將可提供國內製造商在未來醫療器材設計與開發上的參考，除使國內的醫療器材製造商能於國際市場上更有競爭力之外，也可避免因造成患者危害或召回事件所導致的巨額損失。

Since 2007, the medical device industry in Taiwan has an average annual growing rate of 9.2% in compound annual growth rate(CAGR) in sales revenue. Similarly, United States medical device market’s annual revenue has a similar annual growing rate of 9% in CAGR as well. Other than existing products, a big portion of the growth came from innovation and new product development. Along with this growth, medical devices have grown increasingly complex and sophisticated. The growing rate of serious adverse event reports related to medical device is greater than the average annual growing rate in sales by 8% in United States. Even though most medical adverse events were caused by human errors, medical devices also played a critical role to patients’ safety.

In the United States, the infusion pump has caused the greatest number of adverse events out of all medical devices since 2005. In order to discover the major defects associated with medical devices, this study conducted defect analysis on infusion pumps. The medical device recalls were collected from the United States Food and Drug Administrations’ medical device recall database between 2005 and 2011. The defect associated with each recall was analyzed into the following major categories (1) parts (2) alarm system (3) user behavior (4) operator- equipment interface (5) software (6) accompanying documents (7) context of use based on IEC / ISO international standards.

This result can be referenced by medical device manufactures in Taiwan to improve the safety of medical device in design and other perspectives to increase their competitiveness in global market and avoid huge losses caused by device recall.

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