Dive Brief:
- The Food and Drug Administration now recognizes vaporized hydrogen peroxide as an established sterilization method, according to a final guidance issued by the agency on Monday.
- The change is part of the agency’s efforts to reduce the use of ethylene oxide to sterilize medical devices as the Environmental Protection Agency plans to put in place new emissions limits for sterilizers.
- Suzanne Schwartz, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, said the addition of vaporized hydrogen peroxide would help build a more resilient supply chain for sterilized devices.
Dive Insight:
Current established Category A sterilization methods include moist heat, dry heat, ethylene oxide (EtO) and radiation. With the FDA’s recent recognition of a new international consensus standard (ISO standard 22441:2022), vaporized hydrogen peroxide is joining that list.
Previously, it had been a Category B method, which means published information is available, but there is no FDA consensus standard.
The change is expected to pose an alternative to EtO, which the FDA said is used to sterilize roughly half of all medical devices, but is carcinogenic.
Because of the concerns about potential health risks from inhaling EtO, the EPA has sought to regulate the chemical through a pair of rules that would tighten emissions limits for sterilization facilities and increase protections for workers and people who live near these facilities. The former is expected to be finalized in March.
The FDA shares the EPA’s goals, but is also concerned that if device sterilization facilities close, it could result in shortages of equipment.
“FDA shares the Environmental Protection Agency's goal of lowering EtO exposure to workers and to community members while maintaining the integrity of the supply chain,” Schwartz said in a town hall meeting on Wednesday.
The agency’s approach includes innovation challenges on new sterilization methods and ways to reduce the amount of EtO used. It also launched master file pilot programs in 2019 to make it easier for companies to transition to a different sterilization modality.
“Now while some innovations appear promising, other methods of sterilization cannot currently replace the use of ethylene oxide for many key devices,” Schwartz said.
Ryan Ortega, regulatory advisor for CDRH’s Office of Product Evaluation and Quality, said multiple factors drove the recognition of vaporized hydrogen peroxide as an established method.
“Being able to say that we have a scientific understanding of VHP and now to have that recognized consensus standard to support validation and declarations of conformance were really some of the leading points that allowed us to make the update,” he said in the town hall. “But I'd also be remiss if I didn't touch on the fact that information that we learned from the innovation challenge, from actually being participants in standards development, from some of our outreach, and even going back to the advisory committee meeting [in 2019] were all contributors to that update.”
The agency plans to host additional town hall meetings in the future on device sterilization.
Correction: This article has been updated to reflect Ryan Ortega's office within CDRH.
