"A revolution, not an evolution..."Interesting article in Medical Device Daily with perspective from the medical director of Steripro Canada, even if it is 2 months old....
https://www.medicaldevicedaily.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=93272
EYE-LEVEL NO COMPETITION FOR FIRM'S SOLUTION
By David Godkin
Staff Writer
Canada's Tso3 Inc. has won expanded FDA clearance for its Sterizone VP4 sterilizer making it the only company validated to completely sterilize large, complex and hard-to-clean medical instruments, said company CEO Ric Rumble. The Sterizone VP4 Sterilizer, he told Medical Device Daily, is designed to terminally sterilize the superbug and other deadly bacteria which find their way into colonoscopes, gastroscopies and other flexible endoscopic instruments. (See Medical Device Daily, June 27, 2016.) Traditional, eye-level disinfection, he said, just can't compete.
"When we sterilize we destroy a hundred percent of the bacteria on the scope, not just the ones that are growing," said Rumble. "To the best of my knowledge we are the only company that can provide this level of safety. We are it."
The Sterizone VP4 is a low-temperature sterilization system that uses vaporized hydrogen peroxide (H2O2) and ozone (O3) to sterilize double and multiple-channel flexible endoscopes, including ureteroscopes and video colonoscopies. Equipped at one end with precision cameras to capture images of disease, these instruments are up to 3.5 meters long, i.e. longer and harder to clean than small, one meter endoscopes.
"Our sterilizing method of using a variable dose of chemistry and a combination of chemistries," said Rumble, "provides us with the ability to sterilize things which others cannot."
Doing more, doing it faster
Garry Bassi, director of medical device reprocessing at Steripro Canada Inc. in Mississauga, Ontario, told Medical Device Daily about striking efforts to sterilize hard-to-clean multi-channel scopes at the University of Massachusetts. There, technicians cut a suction instrument cross-sectionally and looked inside. "Even after following the manufacturer's instruction for use of the sterilizer, i.e. brushing and flushing contamination, they still found massive amounts of biomaterial and rust inside the lumen."
Typically, instruments treated using sterilizers must be re-treated and tested to confirm successful sterilization, Bassi added. "In those machines, if you have three different devices you have to run three different cycles, each cycle taking one hour." While touring Tso3's manufacturing facility in Quebec City, Bassi was impressed by Sterizone VP4's ability to sterilize high risk instruments in a single cycle for all loads. Nor, he said, are other machines validated to do mixed loads, say a colonoscope, ureteroscope and gastroscope simultaneously. "In the Tso3 machine, you can put all three devices inside the machine under one cycle."
Setting aside Sterizone VP4's use of "green" ozone in its sterilization process, what struck Bassi even more was its ability to dispense the right amount of hydrogen peroxide based on the weight of the load. "It's very clever. It won't dispense the same amount for every load. Instead it detects how much you have inside and dispenses an appropriate amount of H202. That has a cost benefit as well."
A revolution, not an evolution
Bassi's sole criticism centers on Sterizone VP4's reliance on ozone. Most states and some provinces will not permit non-clinical equipment to be plugged into hospital oxygen supply systems. This sterilizer, said Bassi, would require hospitals to invest in a separate stand-alone air compressor, an expensive item at budget-strapped medical facilities.
Not at all, said Rumble. One option would be an inexpensive oxygen feeder tank system or, alternatively, an oxygen concentrator. "It's a small piece of equipment that will scavenge oxygen from the air, concentrate it and feed it to our sterilizer – again, a very low cost, very efficient way of handling it."
Sterizone VP4 sells for approximately US$150,000 per unit with a $25 cycle charge. Quebec, Ontario-based Tso3 has also entered into a global distribution agreement with Sweden's Getinge Group, which previously launched the product in Canada and the U.S. Rumble is particularly excited about the European launch expected in the third quarter of 2016 and remaining launches to occur in 2017.
"This is truly new technology. This is not something that's incrementally better than what was there before. This is leap-frogging earlier technologies," Rumble said.
Published July 26, 2016
FYI, Steripro is a or THE industry leader in Canada for outsourcing sterilization of hospital or clinic instruments. I came upon them in the October 2016 Canadian Business Journal: https://www.cbj.ca/steripro_medical_device_sterilization/
While the Steripro medical director is obviously very positive on the VP4, should they now be offering this revolutionary service in the Toronto area they will be establishing themselves as leaders in the field. I have no info on how many VP4 sterilizers they may have installed at their facilities, (though it might be worth a phone call in the morning). :)