Open AccessMethod Validation and Determination of Leachable Metals from Infusion and Transfusion Medical Devices
Author(s) -
Alexandra Schuh,
Dirce Pozebon
Publication year - 2021
Publication title -
brjac brazilian journal of analytical chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.131
H-Index - 6
eISSN - 2179-3433
pISSN - 2179-3425
DOI - 10.30744/brjac.2179-3425.ar-67-2021
Subject(s) - inductively coupled plasma , inductively coupled plasma atomic emission spectroscopy , inductively coupled plasma mass spectrometry , chemistry , heavy metals , chromatography , environmental chemistry , analytical chemistry (journal) , mass spectrometry , plasma , physics , quantum mechanics
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.