THE Impact of Ethylene Oxide Sterilization on Medical Devices

Abstract

Ethylene oxide gas is commonly utilized for the sterilization of disposable medical devices. However, it is crucial to address the presence of ethylene oxide (EO) and its by-products, ethylene chlorohydrins (ECH) and ethylene glycol (EG), in the sterilized medical devices. High concentrations of these residues can lead to harmful effects on the human body, including hemolytic and irritability of the skin or mucous membranes. To regulate the residual limits of these substances, the FDA proposed guidelines in 1978.  This study focused on investigating the optimal conditions for EO sterilization to ensure effective sterilization while minimizing residual chemical substances.

Keywords: Ethylene Oxide Sterilization, medical devices, ethylene chlorohydrins