Medical Devices – From Licensing To Coverage: Highlights From Argentina, Brazil, Colombia, And Mexico

Objectives: To assess, describe and compare the requirements and pathwaysof medical devices from licensing to coverage in four Latin American countries(LAC) health systems. Methods: We conducted a literature search (February 2015)on Pubmed, Lilacs and Value in Health Regional Issues journal. We also searchedspecific websites of Health Technology Assessment (HTA) and regulatory agencies,ministries of health and health agencies; and a performed generic Internet search.We included all publications describing aspects related to regulation, coverage,medical technology innovation, and HTA and Economic Evaluation (EE) guidelines.We additionally interviewed key informants from all countries to gather informationrelated to the aforementioned processes. We present here the literature searchresults. Results: We included 60 studies out of 2190. Five percent of the publicationsanalyzed the four countries jointly, 75% were from Brazil, 8.3% from Mexico, 5%from Colombia and 5.7% from LAC in general. Half of the studies described the roleof the HTA and EE in decision-making and aspects or policies related to innovation(25% and 23.3%). Regarding the description of the coverage process, it was addressedin 13.3% of the studies; 10% of the publications focused on technovigilance; and also10% on regulatory aspects. Remaining publications were methodological guidelinesand general descriptions of the health systems and the role of medical devices. Allcountries had HTA and EE guidelines, although there did not include device specificrecommendations. There is a spectrum of HTA formalization for technology incorporationafter licensing, higher in Brazil and lower in Argentina Conclusions:There is scarce information on the processes and requirements to achieve coveragefor medical devices in these countries. Processes differ, are in general not explicit,lack transparency, and usually replicate those of drugs not taking into account thespecificities of medical devices.Fil: Rey Ares, Lucila. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Garay, U. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: García Martí, S.. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Gilardino, R.. Johnson & Johnson Medical Argentina; ArgentinaFil: Cabra, H. A.. Johnson & Johnson Medical; MéxicoFil: Pichón-Riviere, Andrés. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Augustovski, Federico Ariel. Instituto de Efectividad Clínica y Sanitaria; Argentin

Interaction of Spherical Silica Nanoparticleswith Neuronal Cells: Size-DependentToxicity and Perturbation of Calcium Homeostasis

The effects of Stöber silica nanoparticles on neuronal survival, proliferation, and on the underlying perturbations in calcium homeostasis are investigated on the welldifferentiated neuronal cell line GT1-7. The responses to nanoparticles 50 and 200 nm in diameter are compared. The 50-nm silica affects neuronal survival/proliferation in a dose-dependent way, by stimulating apoptotic processes. In contrast, 200-nm silica does not show any toxic effects even at relatively high concentrations (292 μ g mL − 1 ). To identify the mechanisms underlying these effects, the changes in intracellular calcium concentration elicited by acute and chronic administration of the two silica nanoparticles are analyzed. The 50-nm silica nanoparticles at toxic concentrations generate huge and long-lasting increases in intracellular calcium, whereas 200-nm silica only induces transient signals of much lower amplitude. These fi ndings provide the fi rst evidence that silica nanoparticles can induce toxic effects on neuronal cells in a size-dependent way, and that these effects are related to the degree of perturbation of calcium homeostasis