FDA Guidelines for Ethylene Oxide Sterilization

The FDA guidelines for ethylene oxide (EO) sterilization ensure medical devices are safe and effective. EO is used to eliminate bacteria and viruses from complex or heat-sensitive equipment. Regulations set standards for sterilization processes, exposure levels, and proper aeration to remove residual EO, which can be harmful if inhaled or contacted. The guidelines require thorough validation, staff training, and routine testing to maintain safety and quality. Overall, they help prevent infection risk while safeguarding public health by ensuring EO-sterilized devices are properly processed and safe for use.