Avaliação da concentração de cobre, prata e bário em amostras de dispositivos intrauterinos comercializados no Brasil

Le résumé fourni par la source

Introduction: Several types of IUDs are available on the national market, but the one provided by the Unified Health System is the one containing copper. Due to the need to control the quality of the device, the Brazilian National Health Surveillance Agency published RDC No. 552/2021, which determines that the purity of Cu must be greater than or equal to 99.9% and the concentration of barium sulfate must be between 15% and 25%. The minimum permitted silver content in intrauterine devices marketed in Brazil is not defined. Objectives: To evaluate the quality of medical devices regarding the concentration of copper, silver, and barium that requested registration to be made available by the Unified Health System. Method: For the determination of copper and silver, 9 samples from 3 different brands were selected. For the barium determination test, 7 samples from 3 different brands were analyzed. Results: The results indicate the importance of monitoring medical devices since we obtained satisfactory and unsatisfactory results. Conclusions: This study reinforces the importance of developing health legislation that determines quality parameters for intrauterine devices containing copper and silver in their composition.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.