TSO3 Inc., an innovator in sterilization technology for medical devices in healthcare settings, has filed with the Food and Drug Administration (FDA) recently completed studies that support an expanded indication for use of its STERIZONE® VP4 Sterilizer. Regulatory clearance of the additional claims would represent an entirely new level of patient protection against ineffective device reprocessing resulting from the use of less robust disinfecting systems, particularly for flexible endoscopes.
The expanded claims sought for the STERIZONE® VP4 Sterilizer correspond to increasing scrutiny by regulatory authorities over medical device reprocessing, particularly for colonoscopes and other complex medical devices used during minimally invasive surgical procedures.
Much of this concern stems from patient-to-patient transfer of multidrug-resistant bacteria that are not inactivated by high-level disinfection. Published reports confirm the significant health risk of device-related transfer of antibiotic resistant microbes, including patient injury or death.
Disinfection is significantly less effective than sterilization because it does not necessarily kill all harmful microorganisms, especially bacterial spores. Low temperature sterilization with the STERIZONE® VP4 Sterilizer offers a more effective solution, since it involves a proprietary physical and chemical process that thoroughly destroys all types of microbiological organisms with a sterility assurance level of 10-6 (SAL-6). Further, the evidence the Company has provided to the FDA confirms that the STERIZONE® VP4 Sterilizer can sterilize up to eight channels in a single device, an industry first for any medical device sterilization process.
"The latest studies continue to support the unrivaled capabilities of our STERIZONE® Sterilization System," says TSO3 president and CEO, R.M. Rumble. "In addition to the already existing multiple advantages of the STERIZONE® VP4 Sterilizer, these milestone results extend the promise of the STERIZONE® VP4 Sterilizer to revolutionize the medical industry's standard of care."
The STERIZONE® Sterilization System has already achieved a number of industry-firsts:
•First and only dual-sterilant sterilizer cleared by the U.S. FDA for sale in the U.S.
•First low-temperature sterilizer with a load-sensitive Dynamic Sterilant Delivery System™
•First documented "wet" cycle with validated micro-condensation sterilant layer
•First Biological Indicator Test Pack to survive past the first half-cycle
•First single cycle, low-temperature sterilizer cleared to process a 75-pound load of general instruments, single channel flexible endoscopes, rigid and semi-rigid channeled device
The STERIZONE® VP4 Sterilizer is a low-temperature (41°C or 105.8°F) sterilization system that utilizes the dual-sterilants of vaporized hydrogen peroxide (H2O2) and ozone (O3) to achieve terminal sterilization of heat and moisture sensitive medical devices. Its single pre-programmed cycle can sterilize a large number and wide range of compatible devices, creating a cost-effective, error-free sterilization process. The device's unique Dynamic Sterilant Delivery System™ automatically adjusts the quantity of injected sterilant based on the load composition, weight and temperature. This capability removes the guesswork and potential for human error, as there is no need to sort instruments and choose the appropriate cycles as with other machines.
The sterilizer is cleared for commercialization in the United States and in Canada.
Source: TSO3 Inc.