A GC-FID validated method for detection and quantification of ethylene oxide in urine bags

Materia

article

José Filipe Bacalhau Rodrigues¹  Juliana Alves da Silva¹  Rebeca Peixoto Medeiros¹  João Vitor Souto de Araújo Queiroz¹  Maria Roberta de Oliveira Pinto¹  Solomon Kweku Sagoe Amoah¹  Marcus Vinicius Lia Fook¹ 

[1] Universidade Federal de Campina Grande

关键词: ethylene oxide;    GC-FID;    urine bags;    medical devices;   

DOI  :  10.1590/S1517-707620230001.1334

学科分类：工程和技术（综合）

来源: Universidade Federal do Rio de Janeiro * Coordenacao dos Programas de Pos-Graduacao de Engenharia

【 摘 要 】

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 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.

【 授权许可】

CC BY