The US Food and Drug Administration (FDA) has recategorized vaporized hydrogen peroxide (VHP) as a sterilization agent, signaling to medical device manufacturers that it has confidence in the agent’s ability to sterilize medical devices. The move is another step by the agency to encourage the use of alternatives to ethylene oxide (EtO) for sterilizing medical devices.
On 8 January, FDA announced it had updated its final guidance on acceptable medical device sterilization methods for premarket applications and moved VHP from an Established Category B sterilization process to an Established Category A sterilization process.
“Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages,” Suzanne Schwartz, director of the Office of Strategic Partnerships and Technology Innovation at the Center for Devices and Radiological Health (CDRH), said in a statement. “As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health.”…
