sterilization Archives - Medical Design Sourcing

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, …

FDA accepts Steris as first contract sterilizer in Radiation Sterilization Master File Pilot to reduce ethylene oxide use

The FDA has accepted Steris as the first contract sterilizer for its Radiation Sterilization Master File Pilot Program.

That program is part of the agency’s initiative to promote new and existing alternatives to ethylene oxide (EtO). EtO is the most commonly used sterilization method for medical devices due to its ability to permeate packaging in bulk quantities. But the medtech industry faces EtO sterilization capacity limits and new regulations that could increase sterilization costs or wait times.

Steris Applied Sterilization Technologies (AST) customers can now use the contract sterilizer’s master file with the FDA to change the way their devices are sterilized, making it easier for them to move from EtO sterilization to gamma radiation.

The master file would also simplify sterilization site changes or processing redudancy additions, moves to non-gamma radiation medthods such as X-ray or electron beam sterilization, and reduced ga…

How Phiex could revolutionize medical device sterilization

CL Tian is co-founder and CEO of Phiex. [Photo courtesy of Phiex]

MedTech Innovator winner Phiex is working with medical device manufacturers on an alternative to ethylene oxide (EtO) sterilization.

The new method uses dry chlorine dioxide gas generated inside the medical device’s product packaging. The powder turns into a microbe-destroying gas when exposed to light, Phiex co-founder and CEO CL Tian said in an interview.

Medical device manufacturers can either integrate the powder into their product packaging or as a secondary pouch. And so far, most devices that can be sterilized with EtO can be sterilized with the Phiex process, Tian said.

EtO is the leading sterilization method for medical devices. Manufacturers and contract sterilization firms use EtO on more than 20 billion medical devices every year, or approximately half of all devices that require sterilization.

But the medte…