TSO3, a provider of sterilization technology for medical devices in healthcare settings, secured 510(k) clearance from the US Food and Drug Administration (FDA) for the terminal sterilization of multi-channeled flexible endoscopes using the firm’s Sterizone VP4 sterilizer.

The approval enables hospital systems such as UCHealth to terminally sterilize gastrointestinal endoscopes, which have dimensions within the cleared intended use.

Duodenoscopes are flexible endoscopes designed to use during endoscopic retrograde cholangiopancreatography (ERCP), which is a procedure that allows physician to assess and capture take images of a patient’s gallbladder, common bile duct, pancreas and liver.

Sterizone VP4 sterilizer is a low-temperature sterilization system, which uses the dual sterilants of vaporized hydrogen peroxide (H2O2) and ozone (O3) to achieve terminal sterilization of heat and moisture-sensitive medical devices.

The device’s single pre-programmed cycle holds capacity to sterilize a range of compatible devices.

Sterizone VP4 also features Dynamic Sterilant delivery system, which automatically adjusts the quantity of injected sterilant based on the load composition, weight and temperature.

Sterizone VP4 is claimed to be the only terminal sterilization method that secured FDA approval to sterilize multi-channeled flexible endoscopes of up to 3.5m in length, including video colonoscopes, duodenoscopes and gastroscopes.

The low temperature sterilizer can also process a mixed load consisting of general instruments, single channel flexible endoscopes, as well as single or double channel rigid endoscopes in the same cycle with load weights of up to 75lb.

TSO3‘s president and CEO Ric Rumble said: “The recent and highly publicized infection outbreaks in the United States associated with the use of flexible endoscopes have highlighted the need for innovative approaches to reprocessing these complex devices.”

UCHealth is a nonprofit health system that manages 10 acute care hospitals and more than 150 clinics across Colorado, southern Wyoming and western Nebraska.

TSO3 provides products for sterile processing areas in the hospital environment, as well as offers services related to the maintenance of sterilization equipment and compatibility testing of medical devices with such processes.