A survey of emerging technologies in selected assistive products

Abstract

Emerging technologies are those which are still in the clinical investigation phase. The incorporation of these innovations into the provision of assistive product-related services requires the strengthening of the surveillance and monitoring system in Brazil. Objective: To identify emerging technologies related to priority assistive products. Method: A research protocol was previously developed and validated by an External Expert Committee. Searches were conducted in the scientific literature databases Clinical Trials, Clinical Trials Registry Platform (ICTRP), and ReBEC. Additionally, a search was performed in the Cortellis database. The studies selected during screening were assessed to verify whether the assistive product was registered within ANVISA. It should be noted that for digital assistive technologies, such as applications and software, resolution RDC 657/2022 indicates that they may not be considered medical devices subject to registration with the Equipment Technology Management Office (GQUIP/GGTPS/ANVISA), as they would not pose a health risk justifying their regulation. Results: Out of 1,435 records identified in the databases, 102 protocols related to emerging technologies were included. Of these protocols, 49 were related to orthoses, 8 to prostheses, 7 to hearing aids, 6 to optical devices, 3 to wheelchairs, and 29 to digital assistive technologies.Conclusion: The results show a discrepancy between the analyzed protocols and actual registrations, which requires greater integration between the study and development stages of assistive products. The findings highlight the importance of continuous monitoring of products without ANVISA registration, ensuring their compliance with regulatory standards. Furthermore, they reinforce the need for transparency in protocols and public access to reliable information on the safety and effectiveness of assistive products.