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In an announcement today, the U.S. Food and Drug Administration (FDA) solidifies vaporized hydrogen peroxide (VHP) as a recognized method of sterilization for medical devices, citing its longstanding safety and efficacy. This move comes as the FDA updates its final guidance on the submission and review of sterility information for devices labeled as sterile, now listing VHP as an example of an Established Category A method of sterilization. The FDA highlights this update as part of its broader strategy to decrease the use of ethylene oxide (EtO) where feasible, thus promoting medical device supply chain resilience.

vaporized hydrogen peroxide

Promoting Safety and Innovation

Effective sterilization processes are crucial for ensuring the safety of medical devices, as they eliminate or neutralize harmful microorganisms without compromising device integrity. While EtO remains the predominant sterilization method in the U.S., accounting for roughly half of sterilized devices sold annually, the FDA has been actively encouraging the exploration of alternatives since 2019. Various initiatives, including pilot programs and innovation challenges, aim to foster the development of new sterilization methods and technologies, reducing reliance on EtO and mitigating associated environmental risks.

FDA's Commitment to Public Health

Dr. Suzanne Schwartz, Director of the FDA's Office of Strategic Partnerships and Technology Innovation, emphasizes the agency's dedication to safeguarding public health amidst the evolving landscape of medical device sterilization. Recognizing VHP as an Established Category A sterilization method bolsters the resilience of the device supply chain, potentially averting shortages and enhancing environmental sustainability. With VHP now joining the ranks of established methods alongside moist heat, dry heat, EtO, and radiation, the FDA anticipates broader industry adoption of alternative sterilization processes aligned with evolving standards and environmental considerations.

Highlights

FDA recognizes vaporized hydrogen peroxide (VHP) as an Established Category A method of sterilization for medical devices, citing its safety and effectiveness.

Update to FDA guidance aims to promote broader adoption of VHP and reduce reliance on ethylene oxide (EtO) for sterilization.

Initiatives since 2019 seek to encourage innovation in medical device sterilization, with a focus on developing alternatives to EtO.

Addition of VHP to Established Category A aligns with FDA's commitment to reducing environmental impact and enhancing supply chain resilience.

FDA

Table of Contents

? Promoting Safety and Innovation
? FDA's Commitment to Public Health
? Highlights
? FDA recognizes vaporized hydrogen peroxide (VHP) as an Established Category A method of sterilization for medical devices, citing its safety and effectiveness.
? Update to FDA guidance aims to promote broader adoption of VHP and reduce reliance on ethylene oxide (EtO) for sterilization.
? Initiatives since 2019 seek to encourage innovation in medical device sterilization, with a focus on developing alternatives to EtO.
? Addition of VHP to Established Category A aligns with FDA's commitment to reducing environmental impact and enhancing supply chain resilience.
?

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FDA Recognizes Vaporized Hydrogen Peroxide

Promoting Safety and Innovation

FDA's Commitment to Public Health

Highlights