TSO3 Inc. announced that the results of the company's clinical in-use and simulated use testing of the terminal sterilization of duodenoscopes have been published in the American Journal of Infection Control. The paper describes innovative testing methods developed and deployed by the company in support of its STERIZONE® VP4 Sterilizer, which has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA), for terminal sterilization of multi-channeled, flexible endoscopes that fall within the specified indications for use, including duodenoscopes. Duodenoscopes are flexible endoscopes used in a procedure called an Endoscopic Retrograde Cholangiopancreatography or ERCP, which enables a physician to perform diagnostic and therapeutic procedures involving a patient's gallbladder, common bile duct, pancreas and liver. Approximately 500,000 ERCP procedures are performed each year in the United States. Antibiotic-resistant infections that resulted in life-threatening infections and deaths have recently been linked to the improper reprocessing of duodenoscopes. Carla Warner of North Carolina knows the devastating impact that Carbapenem-resistant Enterobacteriaceae (CRE), an antibiotic resistant infection, had on her husband, who contracted the infection following an ERCP procedure and died. As recently as June 2018, infections believed to be transmitted via a duodenoscope were reported to the FDA through FDA's Manufacturer and User Facility Device Experience (MAUDE) Database.