| 摘要: |
| 植入类医疗器械的法律责任属于医疗产品损害责任，既有医疗损害责任的特点，又有产品责任的特点。就产品责任而言，医疗机构一般承担无过错责任，即无论医疗机构是否有过错，患方均可向医疗机构追责。且如医疗机构不能指明缺陷产品的生产者，也不能指明缺陷产品的供货者，还应当承担最终责任。在植入类医疗器械的管理使用过程中，医疗机构应从严把采购关，完善购销记录，加强告知及培训，以及医疗器械不良事件报告和监测等几个方面来规避法律责任。 |
| 关键词: 医疗器械 法律适用 产品责任 归责原则 举证责任 |
| DOI： |
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| 基金项目: |
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| Discussion on Legal Responsibility of Implantable Medical Devices in Medical Institutions |
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| Abstract: |
| The implantable medical devices liability belongs to medical product liability，and has the characteristics of both medical damage liability and product liability. In terms of product liability, medical institutions generally need to take responsibility for no-fault. That is to say whether medical institutions have fault or not, patients may apply to the medical institutions accountable. And also if medical institutions can identify neither the producer of the defective product, nor the supplier, they shall bear the liability without fault. In the process of the management and use of the implantable medical devices, medical institutions should strictly focus on purchase quality, improve the purchasing records, strengthen told and training, and medical device adverse event reporting and monitoring to evade legal responsibilities. |
| Key words: medical device, application of law,product liability , principle of accountability, burden of proof |
