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KMID : 1142220170120020107
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Regulatory Research on Food, Drug & Cosmetic
2017 Volume.12 No. 2 p.107 ~ p.116
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Study on Introduction Plan of Damage Relief System for Medical Device Side Effects
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Lee Min-Jung
Kim Sung-Min
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Abstract
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In the case of medical device side effects, the existing remedies such as self-reliance, administrative relief, and judicial relief have difficulties in proving causality between damage and side effects. Therefore, it is actually difficult situation to receive. The purpose of this study was to introduce plan of damage relief system aimed at relieving victims through prompt compensation for medical device side effects. In accordance with this purpose, this study investigate the current state of drug remedy system in December 2014 based on Article 86 of the Pharmaceutical Affairs Law, the characteristics of the equipment, the comparison of the side effect reporting system, the status of the damage relief system for foreign countries, and the analysis. The medical device damage relief system should be introduced when the case database of the damaged medical device is activated and the analysis and evaluation of the side effects through the data information are matured to a considerable extent with the aim of quickly rescuing the damage caused by the side effects of the medical device to the people. Only if it is introduced in time it can be proceeded accurately and quickly. The relief items are gradually expanded from the 4th grade medical device with high risk, and the remedy can be applied to a part of the domestic production income of domestic medical device manufacturing / importing companies. In addition, in the remedial procedure, the method of remedy according to the causal relationship after establishing the clinical evidence through the commissioned study of the medical institution was derived, and a plan for introducing the uniform and rational system was suggested. The introduction of the medical device damage relief system proposed in this study is expected to reduce the burden of burden of proof for the victims, assure active medical care for expedited medical care providers, and reduce the burden of damages for the enterprise.
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KEYWORD
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Social relief, Medical Devices, Adverse Event
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FullTexts / Linksout information
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Listed journal information
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