Ethylene Oxide Gas Sterilization of Medical Devices

Abstract

Ethylene oxide gas is an agent in the sterilization of medical devices due to its effectiveness and compatibility with most materials. The advantages and disadvantages, as well as its recommended uses, are explored in this review article. The variables and their relevance on process optimization are described, the types of processing cycles are detailed and emphasis is given to the design and validation of the sterilization process.

Hydrogen peroxide plasma sterilization of a waterproof, high‐definition video camera case for intraoperative imaging in veterinary surgery

“…Hydrogen peroxide gas is applied at a low temperature that is not harmful to polyethylene or rubber components used in the manufacture of waterproof camera cases and has largely replaced the use of ethylene oxide, which is much more toxic to personnel. 13,14 Results of our study confirmed that manual washing with a standard germicidal detergent followed by hydrogen peroxide gas sterilization effectively eliminated bacteria contamination from the camera cases for 2 different bacterial isolates in all but 1 sample. A single positive culture for the E coli contamination group occurred in the enrichment broth, but, because it was found in the enrichment broth only, it was likely to be present at very low concentrations.…”

“…Chemical sterilization and high level disinfection in health care facilities; https://webstore.ansi.org/Previews/PREVIEW_ANSI+AAMI+ST58-2013.pdf). Hydrogen peroxide gas is applied at a low temperature that is not harmful to polyethylene or rubber components used in the manufacture of waterproof camera cases and has largely replaced the use of ethylene oxide, which is much more toxic to personnel . Results of our study confirmed that manual washing with a standard germicidal detergent followed by hydrogen peroxide gas sterilization effectively eliminated bacteria contamination from the camera cases for 2 different bacterial isolates in all but 1 sample.…”

Risks of Using Sterilization by Gamma Radiation: The Other Side of the Coin

“…Medical materials, tissue allografts and food samples must be sterilized prior to their use 1 . For this purpose, dry heat, ethylene oxide (EtO), formaldehyde, gas plasma, peracetic acid, e-beams and gamma rays, are usually utilized 2 - 4 . Which of these sterilization methods will be used depends on the purpose and physico-chemical properties of sterilized sample 2 - 4 .…”

Vreden Russian Research Institute of Traumatology and Orthopedics

“…Достичь уровня стерильности SAL 10 6 мож-но только при использовании окиси этилена и радиации (ионизирующее излучение дозой не менее 25 кГр) [34,35,42,43].…”

“…потенциальную опасность для пациента составляют остаточные продукты Оэ, такие как этиленхлоргидрин, образующийся в результате реакции с хлоридом, и этиленгликоль, образо-ванный в результате реакций с водой. Оба веще-ства способны вызывать гемолиз и воспаление, а также обладают токсическими, мутагенными и канцерогенными свойствами [42,44].…”