RESUMEN
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.
Asunto(s)
Academias e Institutos , Equipos y Suministros , Estética , Gobierno , Industrias , Estudios Interdisciplinarios , Modelos Teóricos , Academias e Institutos/organización & administración , Colombia , Humanos , Industrias/organización & administración , Medición de RiesgoRESUMEN
This study was designed to assess the effect of time on the repeatability of the LorAn pressure distribution measurement system, and evaluate the variability of plantar pressure and postural balance, during barefoot standing in diabetic and non-diabetic subjects, for future diabetic foot clinical evaluation. Fourteen subjects were evaluated (8 females, 6 males, 8 non-diabetics and 6 diabetics, age range 30-70 years) and had no musculoskeletal symptoms. Four variables were measured with the platform in the barefoot standing position. Ten measurements were taken using two different techniques for feet and posture positioning, during three sessions, once a week. The MANOVA test confirmed that the platform measurements are reproducible for variables body baricenter (x) and foot baricenter (x) through time, being the coefficients of variation, with a 99% confidence interval, lower than 1.6% for body baricenter (x), and lower than 2.06% for foot baricenter (x), for all studied conditions. For the remaining variables, the results were not stabilized through time, which makes necessary to standardize the measurement protocol that guarantees the repeatability in all variables.
Asunto(s)
Diabetes Mellitus/fisiopatología , Fisiología/métodos , Postura/fisiología , Presión , Adulto , Anciano , Fenómenos Biomecánicos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Reproducibilidad de los Resultados , Factores de Tiempo , Soporte de PesoRESUMEN
It has been well documented that subjects with peripheral neuropathy resulting from diabetes mellitus are at high risk of developing foot ulceration. Decreased sensation, in combination with high underfoot pressures, have been identified as prime etiology factors in the cause of plantar naturopathic ulceration [1]. This study presents the effect of four orthotic treatment techniques in reducing metatarsal head, heel and toes pressure during walking. A pressure measurement study was carried out on a diabetic patients group wearing four insoles, including the insole designed by the computer model proposed in this project. The aim of this study was to evaluate the effect on plantar pressure in diverse insoles prescribed and manufactured with various techniques on a random group of patients with diabetes mellitus in the early stages of the disease. Four types of insoles were designed and manufactured by methods available in the market; the computer model proposed on this project was used in order to design and manufacture the insole. The results show that every patient requires an individual assessment and often a personalized insole.