“EO sterilization has continued to advance since the ’60s and ’70s, and while there are still risks, updates to the delivery technology, EO’s materials compatibility, and penetration capabilities mean there are rewards to the modality that you should consider,” said Seth Hendee of Healthmark Industries, Inc. in his article Ethylene Oxide Risk vs Reward.
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…
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.
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.
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.
Andersen Sterilizers has been honored with the 2020 Small Business Environmental Stewardship Award. The medical device manufacturer based in Haw River, North Carolina, was recognized for its high-efficiency, low-emission sterilization process, and its cooperation with State and Federal officials on regulatory and permitting issues.
Andersen Sterilizers is pleased to announce its sister company, Andersen Scientific, has been selected by the Food and Drug Administration (FDA) as one of eight international companies it will collaborate with in the development of strategies or technologies to reduce ethylene oxide (EO) emissions to as close to zero as possible.