Source Analysis of Ethylene Oxide Sterilization Residues in Medical Devices.
10.3969/j.issn.1671-7104.2020.05.015
- Author:
Bodong LIU
1
;
Weigang HE
1
;
Min CHEN
1
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
2-chloroethanol;
ethylene oxide;
medical devices;
residues
- MeSH:
Equipment and Supplies;
Ethylene Oxide;
Humans;
Sterilization
- From:
Chinese Journal of Medical Instrumentation
2020;44(5):443-447
- CountryChina
- Language:Chinese
-
Abstract:
At present, the most commonly used sterilization method for medical devices is ethylene oxide sterilization. The residue after sterilization is closely related to the health of the people who contacted with the medical devices. The study team analyzed the possible residues of medical devices after sterilization with ethyleneoxide. It is suggested that ethylene oxide, 2-chloroethanol and ethylene glycol should be evaluated comprehensively through the analysis of factors such as production links of medical devices, production process of ethylene oxide, sterilization process, sterilization environment and detection method.
