GREY:TSTIF - Post by User
Post by
echo2on Dec 28, 2016 11:00am
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Post# 25646629
And, As If More Examples Are Needed...
And, As If More Examples Are Needed...FDA (and, very grudgingly it would appear from the statements - Olympus) recently reported another sample of contaminated scopes, this time 2 Olympus Vidoe-Ureterorenosocpes, though no associated patient injury or infection was determined.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6134156
It is, again, critical to note that this exact scope is listed as having been tested and determined to be compatible and sterilizable by the VP4 on both the US and Canadian sides of the TSO3 Compatibility Matrix on the website.
It cannot be stated often enough: this scope contamination fiasco has a solution. It is an obvious one to any party interested in the best care in the public interest, especially at the FDA and CDC, if they will lift their head out of the sand: The TSO3 VP4 low temperature sterilizer.
Industry participants outside Getinge and TSO3 may do their best to obfuscate, "take the 5th", and create more committees to discuss and 'recommend' solutions in their own best (financial) interest, but the path forward is clear.
We can expect that more reputable and influencial first adopters such as Mount Sinai New York will help Getinge and TSO3 lead the way!!