ABSTRACT
The urine bag is a thermo-labile medical-hospital device used in clinical/surgical procedures in urine drainage and collection. As it is a thermolabile material, it is commonly sterilized by ethylene oxide, a highly toxic, mutagenic and carcinogenic cyclic ether gas. Currently, several countries require, through documents and standards, the quantification of ethylene oxide in medical and hospital devices. Thus, this work describes the development and validation of a method employed for the quantification of ethylene oxide (ETO) in urine bags. The method was developed based on the guidelines of ISO 10993-7, ANVISA and INMETRO. The work range, linearity, limits of detection and quantification, repeatability, intermediate precision and selectivity were evaluated. Statistical tools such as Levene's test, Grubbs, residual analysis, F-test of two variances, paired sample T test and ANOVA table, were also applied to evaluate the method. The linearity of the work range (10 – 400 mg.L-1) showed an adequate correlation coefficient (r > 0.9993), with a homoscedastic profile with absence of outliers while the limit of detection and quantification were 1,95 and 6,5 mg.L-1 respectively. After validation, 45 samples of urine bags of different batches were evaluated, which demonstrated levels of ETO below the limit of detection (1,95 mg.L-1). The results highlight a simple method that meets several regulations with a wide working range, high sensitivity and capability to quantify ETO not only in urine bags but also in other medical devices.
Keywords
ethylene oxide; GC-FID; urine bags; medical devices