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Model for assessing aesthetic devices based on interdisciplinary work among the government, academy and industry

n Colombia, just the same as in the whole World, globalization of the market led to a large increase in importating of diverse devices. In case of devices for aesthetic use, importing a large number of different device types without adequate control of products, increases the risk of appearance of adverse events for their users. On the other hand, there are very few studies of adverse events caused by their use, or risk assessment studies. This paper presents the role of academy in defining the conditions for safety of aesthetic devices and evaluation of medical devices 'Class 1', for use in aesthetics. With support of the Colombian government, the Pan American Health Organization PAHO, and the regulating entity INVIMA, we proposed a model of control and regulation of use of devices for aesthetics in order to achieve ease of classification and ensure adequate use of devices for aesthetics, and to minimize the risk for users of the technology. As a result of this model, a tool was developed to facilitate to the regulatory entity the classification and evaluation of devices for aesthetic use 'Class 1', which will be implemented by the Colombian government with the support of biomedical engineers having the required knowledge and skills. © 2013 IEEE.

Adverse events; Classification and evaluations; Colombia; Colombians; Diverse devices; Health organizations; Interdisciplinary work; Medical Devices

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