Ethylene oxide, the longtime preferred method of sterilizing medical devices, has been shown to be harmful when breathed in, so MDDI shares several alternatives.
Two years ago, FDA found itself scrambling to prevent shortages after shutdowns of two facilities that use ethylene oxide (also known as EtO, or EO) for medical device sterilization. The threat spurred the agency to initiate two challenges to industry in July 2019: identify new sterilization methods and technologies; and reduce EO emissions. At the same time, FDA launched a voluntary master file pilot program for both medical device manufacturers and sterilization facilities.
For the first innovation challenge FDA issued to industry in 2019, focused on identifying alternative sterilization methods for medical devices, the agency received 24 applications from companies large and small. Of those, FDA selected four participants and five submissions:
NovaSterilis – supercritical carbon dioxide sterilization (scCO2)
Noxilizer – nitrogen dioxide sterilization
STERIS – accelerator-based radiation sterilization
STERIS – vaporized hydrogen peroxide sterilization
TSO3, now a part of Stryker – vaporized hydrogen peroxide sterilization
Read more at MDDI.
Featured image: Ethylene oxide molecule