醫療器材之缺陷到缺陷嫌疑概念的發展軌跡與反思－以德國法及歐洲法院之觀點為中心

醫療器材之研發與革新，和大眾健康之維護具有密切的連動性。特別是在臺灣已進入高齡社會之背景下，吾人與醫療器材有所接觸的機會應會隨之增加；但另一方面，醫療器材亦難謂盡皆能確保運作得宜或絕對安全，從而在填充由醫療器材所觸動之民事損害賠償責任的要件意涵時，有必要進行更細緻的討論。如此一來，在判斷投入醫療器材產業可能衍生之成本時，也可帶來相當助益。在此脈絡下，考慮到缺陷是否存在，乃探究相關民事損害賠償責任時，相當重要之一環，故本文以德國與歐洲法院近年來在面對心律調節器、心律去顫器等醫療器材而生之訴訟案件中，共同浮現之法律爭議問題和回應問題時所提出的觀點為中心，循序引介醫療器材之缺陷及缺陷嫌疑的概念，並剖析其就兩者互動關係之看法，冀能略有助於我國在法律和醫療器材領域交會下的議題深化。

關鍵字

醫療器材；缺陷嫌疑；可合理期待之安全性；德國產品責任法；產品責任指令

並列摘要

The development and innovation of medical equipment are closely linked to the maintenance of public health. Especially with an aged society in Taiwan as background, the chances to come in contact with medical equipment is accordingly increased. On the other hand, medical equipment is not guaranteed to be operated properly or absolutely safe. Thereby, regarding the implication of medical equipment triggering elements of civil liability for damages, more detailed discussions are necessary. In this manner, when calculating potential costs incurred from investment into the medical equipment industry, significant benefits can be gained. In this context, consideration on the existence of defect is quite an important aspect when examining relevant civil liability for damages. The present text takes legal issues and views suggested in response to problems arising from lawsuits due to pacemakers, heart defibrillators, and other such medical equipment faced by both the German Court and the Court of Justice of the European Union as the center, introduces step by step the concept of defect and suspicion of defect of medical equipment, and organizes views on the interaction between the two, so as to slightly assist our nation in deepening the issue under the combination of fields of law and medical equipment.