Beyond Clean Podcast: FDA’s Only 510(k) Clearance for Terminal Sterilization of Duodenoscopes

VENDOR SPOTLIGHT PODCAST

Superbugs Be Gone:
FDA’s ONLY 510(k) Clearance for Terminal Sterilization of Duodenoscopes

Haw River, NC—Picture this: you turn on the news and the announcer leads with breaking news “Infectious outbreak linked to hospital and clinic endoscopes.” Let the media storm and regulatory survey frenzy begin!

As Sterile Processing professionals, this is our industry’s worst nightmare and on a recent Vendor Spotlight, Beyond Clean Podcast talks with Ted May, Andersen Sterilizers CEO, and Dr. Larry Muscarella of LFM Healthcare Solutions LLC about a one-of-a-kind sterilization technology proven to sterilize the toughest endoscopes on the market.

Our FDA clearance marks a significant milestone as the first terminal sterilization solution for duodenoscopes, featured in our latest episode of the “Beyond Clean Podcast.” This innovative, dry process not only offers the highest sterility assurance level of 10^-6, but it also allows for an unprecedented storage capability of up to six months.

Unlike other methods currently available, our approach ensures true sterilization. This breakthrough is poised to transform practices in healthcare facilities, enhancing the safety and reliability of sterilizing these critical instruments.

Ted May

Ted May introduces the EOGas 4 ― the first sterilization system to receive FDA 510(k) clearance for terminal sterilization of duodenoscopes and colonoscopes.

Dr. Muscarella offers his device reprocessing expertise to support the use of ethylene oxide (EO) for endoscope sterilization.

Tune in now to discover how this high-efficiency EO sterilization system is ensuring the highest level of sterility.