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- Title
Desafios globais na avaliação de tecnologias em saúde dos dispositivos médicos personalizados impressos em 3D.
- Authors
Santos Toscas, Fotini; Ferreira Filho, José Alberto; Guimaraes Saad, Luiz Alexandre
- Abstract
Objective: Consolidate information on regulatory aspects, development and implications for the evaluation of personalized medical devices. Methods: Searches were carried out in international technology assessment agencies, consultation of health harmonization documents, public studies of regulatory impact analysis carried out by regulatory agencies from different countries. Results: There is still no robust scientific evidence on the efficacy and safety of 3D printed devices, which means that the patient must be sufficiently informed to be able to give valid consent. The current quantity and quality of evidence and the unique characteristics of these technologies can present challenges in conducting comprehensive technology assessments. Conclusion: The use of personalized 3D printed medical devices has great potential in the healthcare sector, especially in the treatment of specific patient conditions where there are no commercially available technologies, but the state of evidence can be a barrier to their adoption in healthcare services. In order to facilitate the exchange of information and contribute to collaborative research, the adoption of a common term in the studies is imperative. The lack of consensus on terminology can present challenges for the development of technology assessment studies that perform searches dependent on research strategies and literature review, such as economic evaluations and systematic reviews.
- Subjects
REGULATORY impact analysis; TECHNOLOGY assessment; MEDICAL equipment; GOVERNMENT agencies; INFORMATION sharing
- Publication
JBES: Brazilian Journal of Health Economics / Jornal Brasileiro de Economia da Saúde, 2022, Vol 14, p187
- ISSN
2175-2095
- Publication type
Article
- DOI
10.21115/JBES.v14.Suppl2.p187-96