Ethylene oxide sterilization of medical devices: a review.
Ethylene oxide (EO) is a well-known sterilizing agent. However, only recently has its use significantly emerged, based on its range of applications in the field of new medical device development and sterilization. This paper describes the progress in terms of EO sterilization and concludes that it remains a promising field to explore and develop. The EO action mechanism and toxicity are analyzed, and a critical analysis is made on how it is possible to use EO sterilization for medical devices advantageously, with emphasis on cycle design and validation. One huge challenge is related with the development of mathematical models to integrate lethality to allow a continuous increase of process flexibility, without compromising its safety. The scientific community should also focus on other important issues, such as EO diffusion in different substrates, taking into account different environmental conditions both for sterilization and aeration.
Mendes
Gisela C C
GC
Universidade Católica Portuguesa, Escola Superior de Biotecnologia, Porto, Portugal.
Brandão
Teresa R S
TR
Silva
Cristina L M
CL
D003428:Cross Infection / Q000517:prevention & control; D004867:Equipment Design; D004864:Equipment and Supplies / Q000382:microbiology*; D005027:Ethylene Oxide; D006801:Humans; D008954:Models, Biological; D013242:Sterilization / Q000379:methods*; D054928:Validation Studies as Topic
D005027:Ethylene Oxide