TS03 Inc Trust Units TSTIF

RE:RE:RE:RE:RE:RE:RE:RE:News

[echo2]

In getting its own product code, though it is not a predicate device, my understanding is that this sets the VP4 unit apart from others in the category. 

Also note that the FDA, having previously been very upset by Steris and their possibly unauthorized modifications to their OR suite unit, has been extremely demanding and careful with granting this approval. I also suspect that the FDA might have some questions for manufacturers of other H2O2 units regarding the details of the exact process of sterilization for their units, and their abilities to penetrate lumens and eliminate biofilm.

Regarding the 3M ETO units, these use extremely toxic substances and are expensive to operate, though described as effective, there are also some questions about lumen penetration and elimination of biofilm and contaminants in hard to reach places in instruments, (see the paper I sent a link to). These units also all require a special unit attached to detoxify the gas emissions from the units. And, perhaps most importantly of all, the turn around time from putting the intruments into the unit and getting them back out to use varies from 4.5 to 7.75 hours, I believe. This is extremely inefficent, and no better than the original Sterizone with Ozone alone, which is not toxic. The detoxifier unit is recommended to last only 3 years before replacement with use of only 250 cycles per year! In other words, even the company realizes that the units can only do ONE load per day! The Sterizone VP4 can do 4-6 cycles per day! There is absolutely no comparison regarding efficiency, IMHO! 

Again, I hope this clarifies things a bit more. WKH