TSO3 Inc., an innovator in sterilization technology for medical devices in healthcare settings, announced that the US Food and Drug Administration (FDA) has cleared TSO3’s expanded indications for use (IFU’s) of its Sterizone VP4 Sterilizer.

Regulatory clearance of the additional claims represents an entirely new level of patient protection against ineffective device reprocessing resulting from the use of less robust disinfecting systems, particularly for flexible endoscopes.

“Our extended IFU claims have been cleared by the FDA demonstrating the truly superior capabilities of our Sterizone Sterilization System,” said TSO3 president and CEO, R.M. (Ric) Rumble. “These extended claims further expand our technology leadership – offering enhanced patient protection in applications where terminal sterilization was not previously possible. With these enhanced claims, we no longer talk about evolutionary claims advancement; rather the Sterizone VP4 Sterilizer is set to revolutionize the medical industry’s standard of care.”

“We look forward to presenting these enhanced claims in addition to our already industry-leading value proposition to our customers, and will be assessing the need to further expand production capacity in response to customer feedback and demand,” continued Rumble. “I am extremely proud of our team and their unwavering dedication to continue to improve patient care through creating new and meaningful patient infection reduction strategies.”

Testing was conducted to demonstrate the performance of the Sterizone VP4 Sterilizer using both double-channel and multi-channel flexible endoscopes including a ureteroscope and video colonoscope. Testing was also completed demonstrating the effect of the chemistry of the sterilization process against the gross materials present in the test devices. Although, this testing could not confirm material compatibility of all devices (and all manufacturers) that are within the general specifications for each of the load types, customers are encouraged to contact the device manufacturer to ensure compatibility of specific devices with the Sterizone process.

The expanded claims now cleared 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 terminal 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 TSO3 has provided to the FDA confirms that the Sterizone VP4 Sterilizer can sterilize multi-channeled flexible endoscopes (with a maximum of four channels) having internal lumens of = 1.45 mm in inner diameter and = 3,500 mm in overall length, and = 1.2 mm in inner diameter and = 1,955 mm in overall length, which are commonly found in video colonoscopes and gastroscopes - an industry first for any medical device sterilization process.

The Sterizone Sterilization System has now achieved a number of industry-firsts:  First and only dual-sterilant sterilizer cleared by the FDA for sale in the US; First single cycle, low-temperature sterilizer cleared to process a 75-pound load of general instruments, single channel flexible endoscopes, and rigid and semi-rigid channeled devices; First low temperature sterilizer validated to sterilize multi-channeled endoscopes (with no more than four channels) such as video colonoscopes and gastroscopes;  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.

 TSO3 originally filed for expanded indications for use of its Sterizone VP4 Sterilizer with the FDA in December 2015.  In the associated press release, the company indicated that the evidence provided to the FDA confirmed that the VP4 Sterilizer can sterilize up to eight channels in a single device.  These same devices to which the Company was referring were later classified as four channel devices by the Agency due to an interpretation of how a channel is defined.  For clarity, the extended clearance announced today covers all medical devices contemplated in the December 2015 submission.

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 Sterizone VP4 Sterilizer is the only low temperature sterilizer that can process a mixed load consisting of general instruments, single and multi-channel flexible endoscopes, and single or double channel rigid endoscopes in the same cycle with load weights of up to 75 lb. The ability to run mixed loads significantly reduces labor costs by minimizing the amount of instrument sorting required, while maximizing the device turns (more productivity from increased throughput capacity). Other H2O2 sterilizers are limited to load weights of up to only 25 lb and require dedicated fixed cycles for different types of instruments (reducing overall throughput).