TSO3 said today it filed a 510(k) application with the FDA as it seeks to clear its Sterizone VP4 sterilizer for the terminal sterilization of duodenoscopes used in endoscopic retrograde cholangio-pancreatography procedures.
The company’s Sterizone VP4 is a low-temperature sterilization system which uses dual-sterilants of vaporized hydrogen peroxide and ozone for the terminal sterilization of heat and moisture sensitive medical devices. The system has a single pre-programmed cycle which can be used to sterilize a wide range of devices, the Quebec City-based company said.
TSO3 said that if awarded, the approval would make the Sterizone VP4 sterilizer the 1st and only validated sterilizer in the US with an indication for the terminal sterilization of duodenoscopes.
The regulatory filing was backed by laboratory data which the company claims validates that the Sterizone VP4 Sterilizer can terminally sterilize multiple-channel flexible endoscopes with a distal end elevator mechanism.
“This submission is another step towards improving upon the existing standard of care in healthcare sterile reprocessing. Duodenoscopes have historically been defined as “semi-critical” devices, and are not required to have a validated terminal sterilization claim at this time. Our approach has been to demonstrate that these devices can in fact be terminally sterilized and offer healthcare facilities the ability to use our more robust process to process devices known or suspected to be contaminated with multidrug resistant organisms. New US regulatory requirements recently published require manufacturers to provide validated sterilization methods with future submissions for new semi-critical devices such as duodenoscopes, bronchoscopes, gastroscopes, colonoscopes and other endoscopes. TSO3’s unique existing endoscope sterilization claims, along with a potential expanded duodenoscope claim, position the Sterizone VP4 Sterilizer to be an integral part of a healthcare institution’s infection control strategy,” prez & CEO R.M. Rumble said in a press release.
Last July, TSO3 said it won expanded FDA clearance for its Sterizone VP4 sterilizer device, including clearance for sterilizing double and multiple-channel endoscopes.