vaporized hydrogen peroxide Archives - Medical Design Sourcing

Taking medical device sterilization in-house with vaporized hydrogen peroxide (VHP)

Steris LTS-V low temperature sterilizer chambers use vaporized hydrogen peroxide and come in four sizes ranging from 850 L to 9,000 L. [Photo courtesy of Steris]

The FDA’s addition of vaporized hydrogen peroxide (VHP) to its list of Established Category A methods offers an opportunity for manufacturers to bring device sterilization in-house.

VHP can be used as an alternative to ethylene oxide (referred to as EtO or EO) sterilization for many medical devices due to their similar material compatibility profiles. To skip the time and expense of shipping their products to a commercial EtO sterilizer, some device developers are considering adding a VHP sterilization chamber within their own manufacturing facilities.

To help device designers and engineers decide whether VHP is a good fit for their products, Medical Design & Outsourcing spoke with experts at Steris, which uses EtO, radiation and VHP t…

Vaporized hydrogen peroxide for medical device sterilization

A molecular model of hydrogen peroxide (H2O2) [Illustration by petrroudny via Adobe Stock]

Vaporized hydrogen peroxide (VHP) is the latest medical device sterilization alternative to ethylene oxide (EtO) as the industry seeks to limit potential harm from EtO and increase total sterilization capacity.

Vaporized hydrogen peroxide (also referred to as VH₂O₂) is the FDA’s newest addition to its list of Established Category A sterilization methods for medical devices. Other Category A sterilization methods include EtO, dry heat, moist heat and radiation.

Like the aqueous form of hydrogen peroxide (H₂O₂), VHP (also referred to as VH₂O₂) kills infection-causing bacteria, viruses and all other microbial life by oxidizing amino acids and proteins.

VHP has a similar effectiveness as EtO, which is the most commonly used method for medical device sterilization. Like EtO, VHP can permeate many materials …

FDA backs vaporized hydrogen peroxide as medical device sterilization method

The FDA recently announced that it has classified vaporized hydrogen peroxide (VHP) as an established method of medical device sterilization.

On Jan. 8, the agency said it revised its final guidance to list VHP as an Established Category A method of sterilization.

The FDA’s Category A sterilization methods also include moist heat, dry heat, ethylene oxide (EtO) and radiation. These sterilization methods all have a “long history of safe and effective use on medical devices,” the FDA said.

FDA said adding VHP to Category A should facilitate broader adoption of the sterilization method across the medical device industry. It comes as part of years of work with the EPA and medtech industry to reduce the use of EtO where possible. New EtO rules and regulations are expected in the coming weeks.

The FDA also said its backing of VHP further supports the agency’s efforts to advance medical device supply chain resiliency.

EtO, …