TSO3 Receives U.S. Clearance for Extended Claims for Its Medical Device Sterilizer

TSO₃ Inc., a developer of sterilization technology for medical devices, has received U.S. Food and Drug Administration (FDA) clearance for expanded indications for use (IFU) 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.” 
 
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. 

“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,” noted Rumble.
 
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 millimeters in inner diameter and ≤ 3,500 millimeters in overall length, and ≥ 1.2 millimeters in inner diameter and ≤ 1,955 millimeters 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: 
 

• It is the first and only dual-sterilant sterilizer cleared by the FDA for sale in the United States.
• It is the 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.
• It is the first low temperature sterilizer validated to sterilize multi-channeled endoscopes (with no more than four channels) such as video colonoscopes and gastroscopes.
• It is the first low-temperature sterilizer with a load-sensitive Dynamic Sterilant Delivery System.
• It features the first documented “wet” cycle with validated micro-condensation sterilant layer.
• It has the 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. 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 covers all medical devices contemplated in the December 2015 submission.
 
The Sterizone VP4 Sterilizer is a low-temperature (41 degrees Celsius or 105.8 degrees Fahrenheit) 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 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 pounds. 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 pounds and require dedicated fixed cycles for different types of instruments (reducing overall throughput).
 
Founded in 1998, TSO₃’s activities encompass the sale, production, maintenance, research, development and licensing of sterilization processes, related consumable supplies and accessories for heat-sensitive medical devices. The company designs products for sterile processing areas in the hospital environment that offer an advantageous replacement solution to other low temperature sterilization processes currently used in hospitals. It also offers services related to the maintenance of sterilization equipment and compatibility testing of medical devices with such processes.