Ethylene oxide potential toxicity.
The future of ethylene oxide (EO) sterilization has been questioned, owing to its associated toxicity. EO has been around for more than 60 years, mainly due to its recognized characteristics of reliability and effectiveness, coupled with the process flexibility, as well as its compatibility with most mechanical devices. Despite the well-known EO toxicity, the undesirable effects of medical devices' EO residues on the patient's health have not yet been well established. There are limitations related to the current risk-assessment studies. To overcome these drawbacks, demands on greater safety are increasing, which lead to improvements in sterilizers and aeration equipment, as well as the design of the processes. The paper under evaluation highlights risks related to EO sterilization of materials used during processing of stem cells for transplantation, but is an example of a study where the dose of the residues in the devices is not considered.
da Cunha Mendes
Gisela Cristina
GC
Universidade Católica Portuguesa, Escola Superior de Biotecnologia, Rua Dr. António Bernardino de Almeida, Porto, Portugal. gcmendes@mail.esb.ucp.pt
da Silva Brandão
Teresa Ribeiro
TR
Miranda Silva
Cristina Luisa
CL