Registry and surveillance of dental implants: current panorama in the USA, European Union, Brazil and suggestions for improved systems
This study compared and analyzed, after reviewing the literature and the main legal regulations, the requirements for registration and the post-marketing surveillance activities of dental implants in the USA, the European Union and in Brazil. The legal regulations studied showed a concern for risk c...
| Autores: | , , , , |
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| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2016 |
| País: | Brasil |
| Institución: | Fundação Oswaldo Cruz (FIOCRUZ) |
| Repositorio: | Vigilância Sanitária em Debate |
| Idioma: | portugués |
| OAI Identifier: | oai:ojs.visaemdebate.incqs.fiocruz.br:article/648 |
| Acceso en línea: | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/648 |
| Access Level: | acceso abierto |
| Palabra clave: | Dental Implants Medical Device Regulation Technovigilance Post-marketing Surveillance Implantes Dentários Regulação de Produtos para Saúde Tecnovigilância Vigilância Pós-comercialização |
| Sumario: | This study compared and analyzed, after reviewing the literature and the main legal regulations, the requirements for registration and the post-marketing surveillance activities of dental implants in the USA, the European Union and in Brazil. The legal regulations studied showed a concern for risk control and for prevention of failures in the use of dental implants. In the US, the system is centralized, which produces underreporting problems and flaws in the analysis of reporting, as well as a long time between problems identification and the action (due to the extension of the administrative process). In the European Union the few identified studies suggested that the regulatory system provides risks to patients related to the lack of transparency among notifying organs and to the difficulty in articulating the post-marketing surveillance among countries. In Brazil, the post-marketing surveillance is centralized, and is still in its infancy, having the “sentinel” hospitals and “Notivisa” as its main initiatives. Population ageing promotes strong demand for patients’ oral rehabilitation, especially the needy included in the “Smiling Brazil” program. The service demand may offer a market expansion opportunity, but it also poses a risk of low-quality products entry. In this context, the improvement of post-market surveillance activities of dental implants becomes a priority. |
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