TY - JOUR
T1 - Ethylene oxide potential toxicity
AU - da Cunha Mendes, Gisela Cristina
AU - da Silva Brandão, Teresa Ribeiro
AU - Silva, Cristina Luisa Miranda
PY - 2008/1/1
Y1 - 2008/1/1
N2 - 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.
AB - 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.
KW - Ethylene oxide residue
KW - Ethylene oxide sterilization
KW - Medical devices
KW - Process design
KW - Toxicity
UR - http://www.scopus.com/inward/record.url?scp=58549104414&partnerID=8YFLogxK
U2 - 10.1586/17434440.5.3.323
DO - 10.1586/17434440.5.3.323
M3 - Article
AN - SCOPUS:58549104414
SN - 1743-4440
VL - 5
SP - 323
EP - 328
JO - Expert Review of Medical Devices
JF - Expert Review of Medical Devices
IS - 3
ER -