NYT: Experts call for single-use, sterilization or redesign of duodenoscopes, bronchoscopes
Editor's Note Contaminated duodenoscopes have transmitted drug-resistant infections to hundreds of patients, and now some experts are urging the Food & Drug Administration to force manufacturers to develop duodenoscopes that can be properly sterilized or single-use duodenoscopes or take duodenoscopes off the market, the August 6 New York Times Reports.…
Association of US News top ranking for gastroenterology, GI surgical procedures with outcomes
Editor's Note Though the annual volume of gastroenterology and gastrointestinal (GI) advanced laparoscopic abdominal surgical procedures is three-fold higher for US News & World Report’s top-ranked hospitals, the volume does not appear to be associated with improved patient outcomes, this study finds. In this analysis of 51,869 abdominal procedures, the…
Research raises concerns about lubricants used in endoscopes
Current endoscope reprocessing methods are not consistently effective in eliminating organic soil or microbes, and the off-label use of products for defoaming, lubrication, and bleeding control may be contributing to reprocessing failures. Though endoscope manufacturers have cautioned against the use of these products, endoscopists still commonly use them, and many…
Off-label use of simethicone, lubricants, and tissue glue contributes to endoscope reprocessing failures
Editor's Note The off-label use of defoaming agents, lubricants, and tissue glue is common, and these insoluable substances are not removed during reprocessing, this study finds. Of 69 fully reprocessed endoscopes examined in four hospitals, microbial cultures were positive for 50% or more. The researchers, led by Cori Ofstead, MSPH,…
FDA considering additional regulatory actions to reduce duodenoscope risks
Editor's Note The Food & Drug Administration on April 16 announced it is considering additional regulatory actions, including consulting with federal health experts for guidance, to reduce the risks of contamination and infections associated with duodenoscopes. The FDA is also working with manufacturers of disposable duodenoscopes that would make reprocessing…
FDA continues efforts to assess duodenoscope contamination risk
Editor's Note The Food & Drug Administration (FDA) on April 12 announced that it is taking steps to implement additional regulatory actions, including consulting with federal health experts, on how to reduce the risks of contamination and infections linked to duodenoscopes. The agency is also collaborating with manufacturers of disposable…
Elevating standard of endoscope reprocessing with terminal sterilization of duodenoscopes
Editor's Note Terminal sterilization of duodenoscopes can be achieved with a hydrogen peroxide-ozone sterilizer, this study finds. A sterility assurance level of 10-6 was achieved under laboratory worst-case conditions and under clinical conditions using a hydrogen peroxide-ozone sterilizer with regulatory clearance for terminal sterilization of duodenoscopes (STERIZONE VP4, TSO3 Inc,…
FDA issues statement on updated rates of duodenoscope contamination
Editor's Note The Food and Drug Administration (FDA) on December 10 issued a statement on an updated safety communication about rates of duodenoscope contamination obtained from preliminary postmarket data. Interim results from sampling studies from device manufacturers−Olympus, Fujifilm, and Pentax− indicate higher-than-expected contamination rates after reprocessing. Up to 3% of…
First accredited VR continuing medical education course filmed at Cedars-Sinai
Editor's Note The first 360-degree virtual reality (VR) accredited continuing medical education course in gastro-intestinal (GI) surgery was filmed at Cedars-Sinai, Los Angeles, and is now available for streaming, Cedars-Sinai announced on December 3. The course is a collaboration between Cedars-Sinai and the streaming medical platform GIBLIB. The content closely…
Validate and verify medical devices to ensure safety
Sometimes surgeons ask to have nonmedical devices sterilized, such as spoons, hockey pucks, and fish hooks. Healthcare staff may want to accommodate their requests, but there are times when they cannot do so. A central service (CS) should only sterilize medical devices that have undergone validation testing, which demonstrates that…
