Method Validation and Determination of Leachable Metals from Infusion and Transfusion Medical Devices

Abstract

This work deals with method validation for regulated metals (Cd, Pb, Ba, Sn, Cr and Cu) determination in infusion and transfusion medical devices. The investigated metals were extracted with water at (37 ± 1) °C followed by their determination in the extract by using inductively coupled plasma optical emission spectrometry (ICP-OES). The validated method was applied in the analysis of infusion and transfusion devices commercialized in Brazil to verify compliance with current legislation, which establishes that the sum of Pb, Ba, Sn, Cr and Cu in the extract must not exceed 1 mg L-1 and that of Cd must not 0.1 mg L-1. Samples from five manufacturers of infusion and transfusion devices, produced in Brazil or imported, were analysed. The results of the analysis showed that all devices complied with the legislation, whereas the sum of Pb, Ba, Sn, Cr and Cu concentrations and that of Cd in the extract were lower than the maximum permissible; Cd was not detected in any sample extract and the sum of the other elements was < 0.14 mg L-1 in all extracts of the analysed samples.