摘要： 缺陷医疗产品致害责任适用无过错责任归责原则,不合格血液致害责任不应同缺陷医疗产品致害责任相区分。在认定医疗产品是否存在缺陷、血液是否不合格时,应以不合理危险为基本衡量标准,以强制性标准为辅助性标准。本条虽没有明确销售者为责任主体,但按照产品责任的一般规定,销售者同样为缺陷医疗产品致害责任的责任主体。此外,根据《医疗器械监督管理条例》,医疗器械注册人、备案人也应为本条责任主体,在法律适用上应类推适用药品上市许可持有人的规定。缺陷医疗产品及不合格血液致害责任的外部责任形态为连带责任。当本条责任主体明知医疗产品存在缺陷仍使用医疗产品,导致患者死亡或健康严重损害时,仍存在适用惩罚性赔偿责任的空间。医疗机构、销售者、运输者或仓储者等对医疗产品缺陷或血液不合格的产生具有过错时,为最终责任主体;否则,最终责任主体为药品上市许可持有人、医疗器械注册人、备案人、缺陷医疗产品的生产者及血液提供机构。

关键词: 缺陷医疗产品, 不合格血液, 医疗损害责任, 产品责任, 追偿权

Abstract: The liability for damage caused by defective medical products follows the principle of no-fault liability, and the liability for damage caused by substandard blood should not be distinguished from that of defective medical products.When determining the presence of defects in medical products or the qualification of blood, the basic criterion should be the presence of unreasonable danger, with mandatory standards serving as secondary criteria.Although this article does not specify sellers as the liable subject, according to the general provisions of product liability, sellers are also the liable subject for the damage liability caused by defective medical products.In addition, according to the Regulations on the Supervision and Administration of Medical Devices, medical device registrants and filers should also be the liable subject under this article, and the provisions of drug marketing authorization holders should be applied by analogy in the application of law.The external form of liability for damage caused by defective medical products and substandard blood is joint liability, which does not constitute a necessary joint action in the litigation structure.When the liable subject under this article knows that there are defects in medical products and still uses them, resulting in the death or severe health damage to patients, there is still room for the application of punitive damage liability.When medical institutions, sellers, transporters, or storekeepers are at fault in the occurrence of defects in medical products or substandard blood, they should be the ultimate liable subjects.Otherwise, the ultimate liable subjects are the drug marketing authorization holders, medical device registrants, filers, producers of defective medical products, and blood provider institutions.

Key words: Defective Medical Products, Substandard Blood, Medical Damage Liability, Product Liability, Right of Recovery