TSO3 Inc., an innovator in sterilization technology for medical devices in healthcare settings, announces that the Food and Drug Administration (FDA) has cleared TSO3's 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. 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," added 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.
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.