Progress in Safety Evaluation and Usage of Plasticizers in Medical Devices

Abstract

Abstract: ObjectiveTo understand the clinical use and the progress in safety evaluation of plasticizers in medical devices. MethodsThe author sorted several species of plasticizers, and briefly summarized the clinical use of plastical medical devices, then collected the latest data and results of the study on toxicity of plasticizers so as to prove that the plasticizer released from medical devices was potentially harmful to human health and summarized the strategy of safety evaluation of plasticizers. ResultsPlastical medical devices are widely used in clinic, and the addition of plasticizers such as DEHP, carries protential risk and has adverse reactions mainly as reproductive toxicity and hepatotoxicity. The risk assessment of plastical medical devices should be based on the release and intake amount of plasticizers. ConclusionThe discussion on use and safety evaluation of medical plasticizers may provide guidance for the risk assessment and the development of new plasticizers.

Key words: medical devices, plasticizer, clinical use, safety evaluation

CLC Number:

R955

LIN Ni, JIN Hong-tao, WANG Ai-ping. Progress in Safety Evaluation and Usage of Plasticizers in Medical Devices[J]. Chinese Journal of Pharmacovigilance, 2014, 11(2): 100-103.

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