On The Identification Of Defective Medical Devices

How to identify the defectiveness of medical devices is the premise for products liability cases related to medical devices. Currently, the theories about how to identify defective medical devices are relatively shallow. Although standards for defect identification developed during judicial practices are useful in some way, the doubts cast on technical standards have not aroused enough attention, and the current standards are not able to handle the increasing cases in the future with design defect or failure to warn. The legislation and judicial practices of United States are ranked among the world’s best. We may develop the standards with reference to such superior experiences while taking consideration of the fundamental conditions of China and the current judicial practice.The thesis is constituted by three chapters. The first chapter starts with a brief introduction of medical devices, and then focuses on the supervision system of medical devices and the current characteristics of this industry in China. Then, it analyzes the meaning of "defectiveness", the main types of defect and the current standards for defect identification in China. The chapter finally makes a summary of the current judicial condition on this issue and analyzed it with comments.The second chapter conducts a comprehensive research on the standards for identifying defective medical devices in United States, and shows the merits of such standards. This chapter presents an outline of the legislation on medical devices and its driving force of reform which explains how to balance interests during legislation and judicial practice. Then the U.S. standards for identifying defective medicals are presented with case analyses. This chapter also discusses the preemption rules in the same way in order to provide reference about how to place administrative rules, e.g. technical standards, in an appropriate way.The third chapter focuses on how to perfect the standards for identifying defective medical devices with reference to experiences from U.S. This chapter expressly maintains the guidelines during such process, that is, the standards should safeguard the safety and effectiveness of medical devices in order to protect consumers’interests. This chapter also discusses the necessity and urgency for auxiliary systems related to advanced standards.The end of the thesis makes a comprehensive summary of the whole three parts, deeply analyzes the inner driving force for perfecting the standards, and draws the future pictures of applying such standards.