At TSO3 – a leader in innovation within the field of low-temperature sterile reprocessing of medical devices – three goals drive inquiry, experimentation and development: 1. Sterilizing equipment not previously sterilizable 2. Providing robust mixed-load sterilization and 3. Sterilizing more rapidly and, by connection, more cost effectively.
Headquartered in Quebec City, Quebec, with a U.S. office in Myrtle Beach, South Carolina, TSO³ offers distinctive solu-tions to problems competitors have yet to solve. TSO³ received FDA clearance to market the STERIZONE® VP4 Sterilizer in December 2014 and subsequently expanded claims in July 2016 as the only low-temperature sterilizer cleared to terminally sterilize multichannel scopes of up to 4 channels with certain dimensional characteristics. TSO³ markets its products via a multi-year global distribution and service agreement with Getinge Infection Control.
With innovation and improvement at its forefront, TSO³ strives not only to meet today’s standards, but also those that will govern the practice of low-temperature sterilization a decade from now.
TSO³ President and CEO Ric Rumble sat down with OR Today, providing insights into the company and predictions regarding what is yet to come in the field of sterilization.
Q: What advantages does your company have over the competition?
Rumble: Our advantage is pretty simple – our sterilizer can accomplish what no one else’s can. The STERIZONE® VP4 Sterilizer is the only FDA-cleared sterilizer that can sterilize flexible, multi-channel instruments. Furthermore, this sterilizer can hold more items in a load than any other sterilizer. And as if these two advantages weren’t sufficient, users can place a more robust mix of instruments in our sterilizer than in any other available on the market.
These advantages save end users time and money. Most importantly, the benefits allow end users to provide their patients unparalleled care by using a sterilized instrument for each and every procedure, which, given the limitations of other low- and high-temperature sterilizers, was previously impossible.
Q: What are some of the challenges that your company has faced? How have you been able to overcome them?
Rumble: Developing our sterilizing solutions has required a tremendous amount of effort, dedication and perseverance. Two particular challenges most significantly impacted the speed and direction of growth and product development at TSO3:
Industry and regulatory hurdles
Bringing innovation into the marketplace is always a challenge, particularly in the field of sterilization where change happens slowly. Once medical facilities invest in solutions, they often don’t consider alternatives for a decade or longer. In addition, the industry is highly regulated, and product manufacturers must invest a significant amount of time and labor in proving that their products function as advertised and in a safe manner. Interestingly, some of these very issues — and recommendations on how to navigate — were brought to light in a recent OR Today article by infection control specialist Rose Seavey, RN: http://ortoday.com/new-technologies/
The development of the STERIZONE® VP4 Sterilizer meant the introduction of brand new processes to the art of sterilization. Validating these processes took extensive research.
While the rigorous validation process presented a challenge, we at TSO³ recognized the importance of these hurdles and overcame them with hard work and good science.
Robust training requirements
A tool is most effective when its operator understands how to capitalize on the benefits it affords.
When we brought the STERIZONE® VP4 Sterilizer to market, we uncovered the need to retrain operators. Previously, operators had been trained to amass and sterilize loads that fit within the confines of their sterilizers’ limitations. Standard practice meant they couldn’t load certain instruments together, nor could they load over a certain weight capacity.
The STERIZONE® VP4 Sterilizer removed these limitations. Due to the flexibility of our low-temperature sterilizing solution, operators have more options when loading instruments. Additionally, they can enjoy a more rapid turn-around of sterilized instruments, changing the logistical planning that went into stocking and purchasing instruments.
Because we know robust training is requisite to proper product use, we have maintained a close link with end users. By working with the medical professionals who use our sterilizers, we can assess progress and provide training as needed. We also get the chance to witness how our customers benefit from our technology when it’s applied within real-world settings.
Our technicians regularly visit our customer facilities where our products are in use to monitor the functioning of these solutions and provide ongoing support to ensure that we deliver on our promises.
Q. Can you explain the company’s core competencies and unique selling points?
Rumble: Our core competency is creating innovative solutions. We don’t just want to sell sterilizers. We want to provide low-temperature sterilizing solutions that improve upon previous offerings and, in doing so, improve the quality of life for medical professionals and the patients they serve.
Three particularly unique selling points set us apart from our competitors:
Use of a Dynamic Sterilant Delivery System™
Legacy devices used the same quantity of sterilant regardless of the quantity or quality of instruments being sterilized – which seemed nonsensical to us.
The STERIZONE® VP4 Sterilizer uses a dynamic delivery system. As the load changes, so does the chemistry. No two loads run through this system will see the exact same amount of chemistry. Our machine recognizes the load condition and meters the dose of sterilant to maximize sterilization efficacy.
To provide dynamic dosing technology to our customers, we not only had to develop the science that allows for such an offering, but we also had to document the functioning of this system and prove its effectiveness.
Use of dual sterilant
Ours is the only FDA-cleared sterilizer that operates with two distinct chemistries in the same chamber at the same time, thereby increasing the efficacy of the sterilization process.
Use of the microcondensation layer
The STERIZONE® VP4 Sterilizer operates at a low temperature, approximately 40 degrees Celsius. While the environment inside the sterilizer isn’t hot, it is warm enough that a condensation layer forms when devices that are of a cooler temperature are present. Our sterilizer is programed to create an ultrathin layer of chemistry on each device to be sterilized.
Our design capitalizes on the existence of a microcondensation layer. We use this layer to facilitate sterilization.
Q. What excites you most about your products or services?
Rumble: The most exciting element of our business – what gets everyone at TSO³ out of bed each and every morning – is the fact that we are authentically making significant differences in the world of sterile processing.
We are driving down the cost of this process and, by connection, doing our part to drive down the inflating costs of health care.
With our sterilizer, end users can:
- Sterilize more instruments per load than with any other sterilizer
- Sterilize more types of instruments
- Sterilize rigid and flexible instruments together
- Sterilize devices they couldn’t previously sterilize, such as video-gastroscopes and colonoscopes
- Terminally sterilize flexible instruments with multiple channels up to 3.5 meters long – a previously unheard of task
Quite simply, it’s exciting that the team at TSO³ has made the impossible possible and, in doing so, has decreased the cost, and improved the quality, of health care.
Q: What is on the horizon for your company, and how will it evolve in the coming years?
Rumble: At TSO³, we believe that the next evolution in the field of sterilization has already begun.
Today, we can offer customers sterilizing solutions for low-temperature, and many traditionally high-temperature, devices within a single cycle of a single sterilizer.
Driving our continued excitement are the changes we have been able to facilitate within the industry.
For example, we have been able to facilitate the sterilization of duodenoscopes, devices used in Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures. These devices were and continue to be linked to super-bug contamination and, specifically, have been identified as the vector of contamination, causing infections which, in some cases, resulted in death.
We have already established the claim in Canada for specific devices and are now beginning to see these devices sterilized. We plan to position our technology for use in sterilizing these tools in the U.S. as well and have pledged to file with the FDA this year.
Every day, we see the ability of the STERIZONE® VP4 Sterilizer.
We believe that medical facilities should be using a sterile device for every single procedure. Not just surgical, but also diagnostic.
Our fundamental philosophy drives us to create and deploy tools that improve the standard of care in sterility processing.
Q. Have there been any recent changes to your company?
Rumble: The most notable change in the landscape at TSO³ in recent years has been our expansion into the U.S. We have always been a proud Canadian company, calling Quebec City home. However, recently we have made a substantial investment in Myrtle Beach.
With its proximity to multiple deep-water ports, allowing for easy product export, and its robust and stable workforce, Myrtle Beach has become a natural second home. Just like Quebec, it is an excellent location for customer visits and training.
Our expansion into the U.S. includes a laboratory where we conduct compatibility testing. We have established full teams for both research and engineering and built the support capacity necessary to assist facilities in adopting our technologies by providing information on indications along with endorsement letters.
And while there have been many changes in the technologies and methods used throughout
our development as a company, our guiding philosophy has remained consistent – a dedication to innovation. At TSO³, we’re never done exploring or improving. We know that new and innovative procedures are developed each and every day, and we pride ourselves on being innovation leaders in our field.
For more information about TSO3, visit http://www.tso3.com/