TSO3 Inc, a maker of sterilization technology for medical devices, has received a label claim for the Sterizone VP4 sterilizer in Canada that validates the ability to sterilize an Olympus duodenoscope, reportedly cleansing it of transmittable germs.
Duodenoscopes are multichannel endoscopic devices with flexible lighted tubes that are typically threaded through the mouth, throat, and stomach, and into the top of the small intestine (duodenum). They have been directly linked to patient-to-patient transfer of multidrug-resistant bacteria that are not inactivated by high-level disinfection. Published reports confirm the significant risk of device-related transfer of antibiotic resistant microbes, which can lead to patient injury or death.
If a duodenoscope is not meticulously reprocessed, living microbes harbored in residual tissue or fluid from a prior procedure can be transmitted via the scope to a subsequent patient. To help resolve the increasing number of adverse incidents related to ineffectual reprocessing, TSO3 developed the Sterizone VP4 sterilizer and established laboratory data that validates that the sterilizer, with its dual sterilants of hydrogen peroxide and ozone, can repeatedly sterilize the Olympus TJF-Q180V duodenoscope, one of the most common models of duodenoscopes.
The company announced that only this particular Olympus duodenoscope has been validated and is included in its Canadian label claim at this time. However, the company noted that it is planning to meet with the US FDA in early 2016 to discuss the addition of similar language for the company’s label claims in the US.
For more information about the Sterizone VP4 sterilizer, visit the TSO3 Inc website.