| 關 鍵 詞： |
立體列印；客製化的醫療器材；過失侵權損害賠償責任；推定過失損害賠償責任；無過失連帶損害賠償責任 |
| 中文摘要： |
商業化的牙科立體列印系統，已能夠有效率地印製比用傳統方法製作更加精準的客製化復原裝置；有系統能在約 15 分鐘內印好牙體鑲嵌體或人工牙冠以供牙醫師現場安裝。惟，從為患者造影與診斷患者適合何種復原裝置，到為其設計、製作、與安裝專屬的復原裝置之各階段，仍有可能持續短期到長期，從疼痛到死亡的各種風險。在我國執行前揭任何業務皆需先由衛生福利部發予執照。前揭各業務，本文鑑別分為牙體技術業務和醫療業務。倘致人損傷，前者損害賠償責任有消費者保護法賦予企業經營者無過失連帶者，和隨過失程度不同的懲罰性者，後者有醫師法、醫療法、和民法等賦予加害者過失侵權者，與違法且推定過失者。民法並為前揭兩類業務定有後列連帶賠償責任要件：受僱人因過失侵害患者權利者，僱用人負推定過失，以及，數人共同不法侵害他人之權利。本文並分析與探討可能發生於利用牙科立體列印系統為患者製作客製化復原裝置的各階段之不同程度損害，以及損害源於不同加害人於合法或違法執業時，不同專業的加害人與其聘用機構會負擔的不同損害賠償責任。透過前揭分析與探討結果，期使國內各牙科專業人與機構能更清楚評估，在牙科復原專科利用立體列印系統為患者提供客製化裝置的各種利基與潛在法律責任。
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| 英文關鍵詞： |
Three-Dimensional Printing；Customized Medical Device；Fault Liability in Tort for Damages；Presumed Fault Liability in Tort for Damages；and No-Fault Liability in Tort for Damages |
| 英文摘要： |
The three-dimensional printing systems commercially available for dentistry are already capable of producing dental restoration devices more efficiently, accurately, and precisely than those made by traditional methods. Such a system can already print out in about fifteen minutes one unit of dental inlay or of artificial crown ready for a dentist to install in the patient he device was customized for. Nevertheless, different kinds of risks with a certain period of time, from short to long term and with severities from painful to lethal still exist among the processes starting from photographing a patient and diagnosing him/her to decide the most appropriate type of restoration device, and as well as to designing, producing, and installing the device. In Taiwan practicing any one of the professional works in the aforementioned processes requires licenses issued by the Ministry of Health and Welfare. This article categorized the types of aforementioned works as those of “the dental laboratory works” and of “the practices of medicine. ” Practicing business of the former type bears the strict liabilities imposed by the Consumer Protection Act. A trader who injures a patient when practicing business shall bear no-fault liability in tort for damages and additional punitive liability with the level of severity varies with seriousness of the trader's fault. Practicing business of the later type bears the duties imposed by the Physicians Act, the Medical Care Act, and the Civil Code. A natural person and legal person who injure a patient when practicing business shall bear fault liability in tort for damages and presumed fault liability in tort for damages. Furthermore, the Civil Code imposes the following two types of joint liabilities for both types of practicing: the employer shall be jointly liable to make compensation for any injuries which the employee has wrongfully caused to the rights of another in the performance of his duties, and if several persons have wrongfully damaged the rights of one another, they are jointly liable for the injury arising therefrom. This article also analyzed and discussed different types of potential damages which might happen during any of the aforementioned processes, and different associated liabilities for damages caused by different natural persons and legal persons when they legally and illegally conduct different types of work. With the results analyzed and discussed by this article, hopefully, the dental professionals and institutions in our country could evaluate more clearly the potential benefits and legal liabilities for damages resulting from the use of three-dimensional printing systems in dental restoration.
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| 目 次： |
壹、探討之背景
貳、牙科復形與膺復治療技術以及立體列印技術的要點
一、簡介牙科的一些常見復形與膺復治療方式
二、用於牙科復原醫材的立體列印技術概要
三、簡介一些以立體列印術製作的牙科醫材之實例
四、牙齒復原處置或治療的風險
參、一般與嚴格的侵權賠償責任
一、民法的一般侵權行為責任
二、消費者保護法
三、消費者保護法與醫療法之競合
肆、辨析消費者保護法對牙科業者的損害賠償責任之規範
一、牙醫師
二、牙體技術師／生
伍、牙科業者應用立體列印技術於業務之損害賠償責任
一、不安全的牙科復原裝置
二、安裝未盡安全
陸、結語
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