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Model for assessing aesthetic devices based on interdisciplinary work among the government, academy and industry
- Source :
- EMBC
- Publication Year :
- 2013
- Publisher :
- IEEE, 2013.
-
Abstract
- In 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.
- Subjects :
- Government
Engineering
Class (computer programming)
Esthetics
Management science
business.industry
Control (management)
Academies and Institutes
Interdisciplinary Studies
Colombia
Models, Theoretical
Risk Assessment
Globalization
Equipment and Supplies
Work (electrical)
Risk analysis (engineering)
Order (exchange)
Humans
Industry
Health organization
Risk assessment
business
Subjects
Details
- Database :
- OpenAIRE
- Journal :
- 2013 35th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC)
- Accession number :
- edsair.doi.dedup.....6c4db45ddab8ecf6f85947d3a7b33910