Problems associated with sterilization using ethylene oxide. Residues in treated materials.

Abstract

The paper deals with problems associated with reduction of undesirable effects of ethylene oxide in polymers in medical devices on the patient's health. The authors explain the need of careful elaboration and validation of the sterilization and aeration process incl assessment of ethylene oxide (EO) residues. The authors investigated the effect of the type of material and conditions of sterilization and aeration on the assessed EO concentration. For research of the behaviour of different polymers in the sterilization process model sterilizations of actual items of medical devices with a known composition proved more suitable than assessment in medical devices from medical institutions. The main conclusions of the investigation were a classification of polymers into those suitable and unsuitable for sterilization or resterilization, and attention was also drawn to poor reproducibility of results in old sterilizers, in particular those lacking effective aeration in aerators.