March 20, 2024- Sterilization is a critical step in the manufacturing process for certain medical devices. Sterilization of medical devices helps prevent serious infections. Inadequate sterilization can lead to life-threatening infections.
Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat, radiation, ethylene oxide (EtO) gas, vaporized hydrogen peroxide, and other sterilization methods (for example, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide).
On March 21, 2024, the FDA will host the next in a series of medical device sterilization town halls to discuss:
- The value and use of consensus standards in premarket review
- The role of the CDRH Standards program in the development and recognition of consensus standards
- Recently recognized consensus documents for device sterility and their potential use in premarket review, and
- The value of participating in the collaborative standards development process.