TSO3 to publish innovative validation method linked to sterilization of multichannel endoscopes in upcoming issue of the Canadian Journal of Infection ControlWednesday, April 19, 2017
Québec City, Canada/Myrtle Beach, USA, April 19, 2017 – TSO3 Inc. (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, announced today that an original paper has been accepted for publication in the peer-reviewed Canadian Journal of Infection Control. The paper describes the first and only gravity based direct inoculation (intentional bacterial contamination) method which meets the requirements of US regulators for confirmation that the inoculum is deposited into the middle of each channel of complex multichannel endoscopes. Additionally, the paper describes the TSO3 STERIZONE® low temperature sterilization system and its ability to sterilize such scopes.
The paper, co-authored by Dr. Sylvie Dufresne and Dr. Thomas Richards, discusses TSO3’s unique inoculation method for targeting the most challenging location within the long narrow flexible channels found in devices such as colonoscopes. This new methodology was a necessary precursor to validating effective sterilization of these scopes by the STERIZONE® VP4 Sterilizer. Until now, numerous methods have been published on how to inoculate and recover test organisms for use in sterilization validation studies, but typically these methods have been validated for only simple lumen devices.
The paper highlights how this new method satisfied the requirements of the US Food and Drug Administration (FDA) for targeted inoculation and recovery efficacy, and also demonstrates that the STERIZONE® VP4 Sterilizer can achieve a sterility assurance level (SAL) of 10-6 using this enhanced method. The paper additionally discusses how the inoculation method and the sterilizer performance were validated using high and low level recovery methods as well as half-cycle, simulated-use, and “in-use” clinical testing.
“We are excited to share this innovative method with the scientific and medical communities and are pleased to have peer confirmation of the science behind our industry changing sterilization technology and our rigorous approach to validating its effectiveness.” stated R.M (Ric) Rumble TSO3’s President and CEO. “This is the first published paper documenting an effective inoculation and recovery method of a modern multichannel GI endoscope and its subsequent sterilization using a vapor-based sterilant. The significance of this work reaches into tens of millions of reprocessing cycles practiced annually and reinforces TSO3‘s expanding clinical and economic opportunity.”
About the STERIZONE® VP4 Sterilizer
The STERIZONE® VP4 Sterilizer is a low-temperature 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 sterilization process with error free cycle selection. 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 terminal sterilization method that is FDA cleared to sterilize multi-channeled flexible endoscopes (with a maximum of four channels) of up to 3.5 meters in length, such as video colonoscopes and gastroscopes - an industry first for any medical device sterilization process.
The STERIZONE® VP4 Sterilizer is also the only cleared low temperature sterilizer that can process a mixed load consisting of general instruments, single 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).
More information about the STERIZONE® VP4 Sterilizer is available through TSO3's website, under the Products section at http://www.tso3.com/en/products/sterizone-vp4/.
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. TSO3 also offers services related to the maintenance of sterilization equipment and compatibility testing of medical devices with such processes.
For more information about TSO3, visit the Company's website at www.tso3.com
The statements in this release and oral statements made by representatives of TSO3 relating to matters that are not historical facts (including, without limitation, those regarding the timing or outcome of TSO3's sales, business or operations) are forward-looking statements that involve certain risks, uncertainties and hypotheses, including, but not limited to, the ability of the Company to obtain the required regulatory clearance to market its products on a worldwide basis; general business and economic conditions, the condition of the financial markets, the ability of TSO3 to obtain financing on favourable terms and other risks and uncertainties. Although TSO3 believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to have been correct. The complete versions of the cautionary note regarding forward-looking statements as well as a description of the relevant assumptions and risk factors likely to affect TSO3’s actual or projected results are included in the Management’s Discussion and Analysis for the year ended December 31, 2016, which is available on the Company’s website. The forward-looking statements contained in this press release are made as of the date hereof and TSO3 does not assume any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise unless expressly required by applicable securities laws.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities, in any jurisdiction in which such offer, solicitation or sale would be unlawful.
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Source: TSO3 Inc.
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