Breakthrough Med Device Sterilization Technology Uses Nitric Oxide

Not to be confused with laughing gas, this “molecule inside a polymer” is poised to offer safe sterilization of medical devices to kill microorganisms without the environmental issues brought by EtO sterilization.

Billions of medical devices are sterilized with ethylene oxide (EtO) each year. While EtO has made headlines and caused facility closures for unsafe environmental exposure and resulting health risks, for many years, there was no readily available process to serve as an alternative for medical device sterilization.

In 2019, the FDA set up innovation challenges to identify new sterilization methods and reduce EtO emissions. With limited facilities and significant device volumes, EtO sterilization providers become impacted leading to long lead times for sterilization.

This technology, nitric oxide (NO) inside a polymer, was announced May 9. If successful, it could help assuage industry fears about having sufficient sterile medical devices while reducing risks to environments and worker safety.

Dr. Frost, CTO at Sterile State LLC, has worked on technology for 20 years, perfecting the sterilant and delivery system: “I started out using this technology to make implanted medical devices. The reason I’m telling you that is because it’s a really safe technology, and it was developed to be at a standard much safer than what we used for packaging devices that aren’t actually going to be implanted within the human body.” 



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