The U.S. Food & Drug Administration recently issued a letter to healthcare providers regarding changes to reprocessing methods for certain urological endoscopes manufactured by Karl Storz, due to infection risk. The letter can be found here. An excerpt follows: “As the U.S. Food and Drug Administration (FDA) continues to evaluate the risk of patient infections and contamination issues associated with ...
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ESGE and ESGENA position statement on gastrointestinal endoscopy and the COVID-19 pandemic
The outbreak of COVID-19 disease due to the SARS-CoV-2 virus has recently spread from its original cluster in Hubei province, China throughout the world, and has been declared to be a pandemic by the World Health Organization. Europe is severely affected with an exponential increase of number of COVID-19 cases and deaths. The European Society of Gastrointestinal Endoscopy (ESGE) and ...
Read More »FDA clears GI Scientific’s ScopeSeal single-use disposable endoscopic shield
GI Scientific, LLC, a developer of transformative innovations for gastrointestinal disease, announced that the U.S. Food and Drug Administration (FDA) cleared its ScopeSeal Duodenoscope Protective Device, an endoscopic shield for protecting the distal end of a duodenoscope from contamination during ERCP procedures. ScopeSeal is a single-use disposable infection control device that preserves duodenoscope optics and other key functionality while sealing the ...
Read More »Study reveals how mucus tames microbes
More than 200 square meters of our bodies — including the digestive tract, lungs, and urinary tract — are lined with mucus. In recent years, scientists have found some evidence that mucus is not just a physical barrier that traps bacteria and viruses, but it can also disarm pathogens and prevent them from causing infections. A new study from MIT ...
Read More »STERILUCENT, INC. ANNOUNCES CLEARANCE TO MARKET NEW LOW-TEMPERATURE STERILIZATION SYSTEM
New sterilizer’s unique features address longstanding process challenges Sterilucent, Inc. (Minneapolis, MN), announces that the company has received regulatory clearance to market the Sterilucent™ HC 80TT Vaporized Hydrogen Peroxide Sterilizer with Cycle Guardian™ technology in the United States. Cycle Guardian technology includes: Advanced and continuous critical parameter monitoring capability, which enables advanced dynamic sterilant delivery, confirms that the minimum required concentration of the ...
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