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


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 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 is the first terminal sterilization clearance for duodenoscopes. We’re offering a dry process that allows you to store scopes for up to 6 months and it’s offering a 10-6 sterility assurance level. This is true sterilization unlike the other options on the market. I think this is going to be a real game changer for healthcare facilities that want to sterilize these very 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.

Beyond Clean Podcast: FDA clearance for the EOGas 4
EOGas 4 FDA 510(k) Resources

Printable Press Release

EOGas 4 510(k) – K192978

FDA Letter
Indications for Use

Endo-SteriTest Rapid BI 510(k) – K202879

(Self-contained biological indicator – 4 hour incubation)

FDA Clearance

Endo-SteriTest BI 510(k) – K192980

(Self-contained biological indicator)

FDA Letter
Indications for Use

Andersen’s new version of the EOGas 4, featuring a 6-hour cycle, has been put into production immediately upon receiving the clearance.

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