论缺陷医疗器械损害中质量检验的完善——从一例医疗器械损害赔偿案说起

Improvement in Quality Inspection of Defective Medical Devices Based on One Case Report of Medical Devices' Damages

在医疗器械损害赔偿案件中,"缺陷"是生产者是否承担赔偿责任的核心要件,因此认定产品缺陷的质量检验显得格外重要。随着医疗器械的飞速发展,医疗器械工艺日趋复杂,目前关于医疗器械产品缺陷的认定标准存在较多争议,影响了检验的科学性。其次,检验机构和检验人员作为检验结论的实施者,也存在诸多问题,特别是需要明确其法律地位。再次,如何对检验意见进行审查,使其具有证据价值,也具有非常重要的意义。本文拟从缺陷医疗器械损害的质量检验作为切入点,结合本文案例,对司法实践中处理缺陷医疗器械损害责任中的认定标准、检验机构、检验意见的审查评断等疑难问题进行探讨,以期促进缺陷医疗器械损害的质量检验的完善。

In cases of medical devices＇ damages,the word of ＂defect＂ is the core element whether producers assume the liability,so that quality inspection of product defect is particularly important.With the rapid development of medical devices,technique of medical equipment is growing more complex.At present,there is much controversy in standards of medical devices defect,which affects the scientific nature of inspection.Secondly,inspection agencies and inspectors as operators of test have faced many problems,especially in need of clarifying their legal status.At last,how to review the inspection opinion with evidentiary value is also significant.This article will firstly concern with the quality test of defective medical devices＇ damage on the basis of the case report,and then explore and analyze some difficulties in the inspection of defect,such as standards,inspection bodies,review and judgment of test opinion,in order to promote the quality inspection of defective medical devices.