超頻音波拉皮燙傷案：醫療器材仿單外使用之風險認知【學習式判解評析】 試閱
Burn by High-intensity Focused Ultrasound for Facelift：Risks of Off-Label Use of Medical Devices
醫療器材未依仿單說明使用在適應症外之用途，此為醫療器材之仿單外使用，相較於藥品之仿單外使用，關於醫療器材off-label use較少討論，而低估此種醫療行為可能造成之風險，輕縱濫用醫療器材導致身體健康受損者，尤以美容醫學為甚，本文主要提醒對於醫材仿單外使用可能之風險以及如何適用告知同意法則在此類案件中，俾使法界及醫界加以正視。
Off-label use of medical device means manipulation of medical device without following the label or indications. Compared to off-label use of drugs, off-label use of medical devices is rarely discussed and its risk could be underestimated, especially in aesthetic medicine, where ignoring off-label use of medical devices could lead to health damage. This essay aims to discuss the risk of offl-abel use of medical device and how to apply the principle of informed consent in this kind of case to emphasize the importance.
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