FDA Recognizes Hydrogen Peroxide for Sterilization of Medical Devices

The agency supports the broader adoption of vaporized peroxide as an alternative to sterilizing with ethylene oxide.

The U.S. Food and Drug Administration (FDA) announced that vaporized hydrogen peroxide (VHP) is safe and effective as an established method of sterilization for medical devices. The agency has revised its guidance regarding the categorization of VHP as part of the effort to reduce the use of ethylene oxide.

The FDA stated, “While ethylene oxide sterilization is a necessary part of the manufacturing process for many medical devices, there have been concerns recently about its effects on people who are exposed (or overexposed) to it—and there are concerns about environmental emissions.“ The chemical was listed in the Environmental Protection Agency’s National Air Toxics Assessment.

“The FDA’s commitment is to protect public health, a critical mission in today’s complex medical device ecosystem,” said the Center for Devices and Radiological Health Office of Strategic Partnerships and Technology Innovation Director Suzanne Schwartz. “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. 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.”

As the Lord Leads, Pray with Us…

  • For Commissioner Robert Califf to be prudent as he heads the Food and Drug Administration.
  • For discernment for Administrator Michael Regan as he oversees the Environmental Protection Agency.
  • For U.S. officials as they shift policies to protect public health and the environment.

Sources: Food and Drug Administration, Environmental Protection Agency


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