In July 2019, the U.S. Food and Drug Administration (FDA) announced two innovation challenges to encourage the development of new approaches to contract sterilization of single-use medical devices. On November 25, 2019, the Agency announced that 46 applications were received as part of the challenge and 13 were selected.
STERIS is excited to announce that all three of its applications were accepted by the FDA and, as a result, will work with the Agency to accelerate the development and review of innovative technologies.
About the Innovation Challenges
The innovation challenges were developed to encourage ideas from academics, industry and others about novel solutions for improving processes used for the contract sterilization of single-use medical devices.
- Challenge one: Identify alternatives to ethylene oxide sterilization methods
- Challenge two: Develop strategies to reduce ethylene oxide
STERIS Applied Sterilization Technologies (AST) submitted three proposals as part of the challenge:
- Sustainable EO® Sterilization Services (challenge two)
- Terminal Sterilization of Medical Devices Using Accelerator-Based Technology (challenge one)
- Terminal Sterilization of Medical Devices Using Vaporized Hydrogen Peroxide (challenge one)
Go here to learn more about our global contract sterilization and microbial reduction services using a technology-neutral offering of radiation and gas technologies.