In January 2024, the U.S. Food and Drug Administration (FDA) officially recognized vaporized hydrogen peroxide (VHP) as an Established Category A sterilization method for medical devices. This reclassification acknowledges VHP’s long-standing safety and effectiveness, simplifying the regulatory process for manufacturers utilizing this sterilization technique.

Understanding the FDA’s Reclassification

Previously categorized as a Category B method, VHP’s promotion to Category A reflects its proven reliability in sterilizing medical devices. This change means that manufacturers employing VHP can now navigate a more streamlined regulatory pathway, facilitating quicker market access for their products.

Implications for Medical Device Sterilization

Ethylene oxide (EtO) has been the predominant sterilant for medical devices in the United States, accounting for approximately 50% of sterilized devices. However, concerns about EtO’s environmental impact have prompted the FDA to encourage alternative sterilization methods. The recognition of VHP as a Category A method supports this initiative, offering a viable, environmentally friendly alternative to EtO.

Delox’s Commitment to Innovation in Bio-Decontamination

At Delox, we are inspired by the FDA’s recognition of VHP and remain dedicated to expanding our portfolio of bio-decontamination solutions. This development aligns with our mission to provide safe, effective, and environmentally conscious sterilization options to diverse sectors.

For more information on the FDA’s reclassification of VHP, visit the official announcement here.