Patients Ask: Is High-Level Disinfection Enough?
| |

Patients Ask: Is High-Level Disinfection Enough?

In October 2024, after Vanderbilt Health notified an unspecified number of patients that they may have been exposed to HIV, hepatitis B and hepatitis C during endoscopy procedures, patients and healthcare workers across the country took notice. Many asked whether the current standard of care for endoscope decontamination, high-level disinfection (HLD), is adequate to ensure…

Andersen Sterilizers & Andersen Scientific First Awardee in FDA’s 510(k) Ethylene Oxide Sterility Change Master File Pilot Program
|

Andersen Sterilizers & Andersen Scientific First Awardee in FDA’s 510(k) Ethylene Oxide Sterility Change Master File Pilot Program

HAW RIVER, N.C. – Andersen Sterilizers and its sister company, contract sterilization specialist Andersen Scientific, were awarded the very first master file in the FDA’s 510(k) Ethylene Oxide (EO) Sterility Change Master File Pilot Program. “This master file award from the FDA makes it official, switching to Andersen from a traditional sterilization method just got…

FDA investigates urological endoscopes
|

FDA investigates urological endoscopes

The Food and Drug Administration (FDA) announced it is investigating reports of infections associated with reprocessed urological endoscopes. The FDA received more than 450 medical device reports (MDRs) describing post-procedure patient infections or other contamination issues associated with reprocessing urological endoscopes. Andersen’s EOGas 4 presents an FDA-cleared terminal sterilization option for the urological endoscopes under investigation, as well as significantly longer and smaller diameter scopes.

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

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

Andersen’s EOGas 4 is the first, and only, sterilization system FDA 510k cleared for terminal sterilization of duodenoscopes and colonoscopes. A true game changer for healthcare facilities that sterilize these critical instruments. On a recent Beyond Clean podcast, Ted May, Andersen President and CEO, and Dr. Larry Muscarella of LFM Healthcare Solutions LLC, take you inside the science behind this one-of-a-kind sterilization technology proven to sterilize the toughest endoscopes on the market.

EOGas 4 receives FDA clearance for duodenoscopes
|

EOGas 4 receives FDA clearance for duodenoscopes

Andersen’s EOGas 4 has received FDA 510(k) clearance for the only terminal sterilization solution for duodenoscopes and colonoscopes. With this clearance, the EOGas 4 sterilization system reflects the FDA’s latest validation expectations for terminal sterilization of lumened devices, including those with elevator mechanisms.