FDA updates guidance on medical device sterilization methods

January 9, 2024- The FDA announced that it now considers vaporized hydrogen peroxide (VHP) to be an approved method of sterilization for medical devices, according to a January 8th update. Effective sterilization processes are necessary for certain medical devices to be safe, as sterilization kills harmful microorganisms, according to the FDA.

The change is expected to facilitate VHPs as a sterilization method, and is part of a larger plan to reduce the use of ethylene oxide — the most commonly used method for devices in the U.S. — and encourage the development of alternatives.

The guidance revision is for the makers of medical devices, which for devices labeled as sterile must demonstrate their sterilization process is effective and consistent with consensus standards recognized by the FDA. 

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