Word GamesThis week, Tso3 issued a press release where Rumble stated:
The expanded claims sought 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. The claims sought in the U.S. represent similar claims for the STERIZONE® VP4 Sterilizer already available in Canada (My bold) and those which will accompany t
But what are those claims? Either explicitely or implicitely, the two financial analysts who wrote a piece following the latest news, and I suspect many people on this board, assumed we are dealing here with the so-called extended claims version of the VP4, the one supposed to demonstrate that the VP4 could handle complex, long flexible multi-channels endoscopes. And indeed, Tso3 stated as much in a press release in late October 2015:
Qubec City, Qubec – October 26, 2015 – TSO3 Inc. (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, has received clearance from Health Canada, the Canadian equivalent of the Unites States FDA, to sell the STERIZONE® VP4 Sterilizer with extended claims in the Canadian market place.
With these claims, the TSO3 STERIZONE® VP4 Sterilizer becomes the only low temperature sterilization system available in the market today that is capable of sterilizing complex medical instruments, such as colonoscopes and other multi-channel flexible scopes.
Check the date : Oct 23 2015
Fastforward to Dec 17, 2015, another press release:
Qubec City, Qubec – December 17, 2015 – TSO3 Inc. (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, has added to its label claims for the STERIZONE® VP4 sterilizer in Canada that validates the ability to sterilize a specific duodenoscope.
...
TSO3 has established laboratory data that validates that the STERIZONE® VP4 sterilizer, with its dual sterilants of hydrogen peroxide and ozone, can repeatedly sterilize the Olympus TJF-Q180V Duodenoscope, the industry’s leading brand and model of duodenoscope.
“We believe we are the first to validate terminal sterilization of such a device,” noted TSO3 president and CEO, R.M. (Ric) Rumble. “This breakthrough comes at a critical time, with the growing use of Duodenoscopes, along with the increasing number of adverse incidents related to ineffectual reprocessing.”
Only this particular Olympus Duodenoscope has been validated and is included in our Canadian label claim and Rumble points out that TSO3 does not expressly or implicitly claim that the medical device manufacturer has cooperated in performing the tests or has endorsed the test results.
“We are planning to meet with the U.S. FDA in early 2016 to discuss the addition of similar language for our claims in the U.S.,” added Rumble. (My bold)
Fastforward a week later, Dec22, 2015:
Qubec City, Qubec – December 22, 2015 – TSO3 Inc. (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, has filed with the U.S. Food and Drug Administration recently completed studies that support an expanded indication for use of itsSTERIZONE® VP4 Sterilizer.
Regulatory clearance of the additional claims would represent an entirely new level of patient protection against ineffective device reprocessing resulting from the use of less robust disinfecting systems, particularly for flexible endoscopes.
The expanded claims sought for the STERIZONE® VP4 Sterilizer correspond to increasing scrutiny by regulatory authorities over medical device reprocessing, particularly for colonoscopes and other complex medical devices (My bold) 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.(My old)
A comment: Eventhough the word Duodenoscope is not used, everything points to that. Which rings us back to the first quote, the one from the pree releaseof earlier this week:
The claims sought in the U.S. represent similar claims for the STERIZONE® VP4 Sterilizer already available in Canada (My bold)
And indeed, as can be seen in a table from Health Canada reproduced in the link below, Tso3 has only three valid licenses in Canada;.the original 125L, the original VP4 and the full blown VP4 that followed clearance to handle the TJF-Q18 while the so-called extende version has been relinquished.
A long demonstration to show that Rumble might be right we he said:
“The questions and statements received are typical and consistent with the seriousness of elevating the standard of reprocessing for these extremely challenging medical devices,” continued Rumble. “The minimal testing is planned or already underway, and we have requested meetings with the agency to discuss the work.”
After all there are not many duodenoscopes on the market.
Frrom HC
https://www.dropbox.com/s/mv0po9rdgirwdv8/hcmarch16E.GIF?dl=0