In updated guidance for makers of medical devices labeled as sterile, the Food and Drug Administration Jan. 8 listed vaporized hydrogen peroxide as an established sterilization method for medical devices, part of the agency’s effort to facilitate alternatives to ethylene oxide sterilization.

“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,” said Suzanne Schwartz, M.D., director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health. “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.”

Related News Articles

Headline
The Food and Drug Administration has identified a Class I recall of Edwards Lifesciences OptiSite Arterial Perfusion Cannula devices due to the potential for…
Headline
The Food and Drug Administration has identified a Class I recall of certain lots of Medline Industries Craniotomy Kits containing recalled Codman…
Headline
The Food and Drug Administration July 21 identified Class I recalls of two products due to the potential for serious injury or death. Integra LifeSciences…
Headline
The Food and Drug Administration July 15 announced a recall by Sandoz on certain lots of cefazolin, due to the lots being mislabeled as penicillin G potassium…
Headline
The Food and Drug Administration issued Class I recalls, the most serious type, for two Smiths Medical infusion pumps due to the potential for serious injury…
Headline
The Food and Drug Administration has identified a Class I recall of certain lots of BD esophagogastric balloon tamponade tubes due to the potential for serious…