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TS03 Inc Trust Units TSTIF



GREY:TSTIF - Post by User

Comment by echo2on Jan 13, 2016 3:11pm
249 Views
Post# 24455033

RE:The Dirty Scopes -- Again

RE:The Dirty Scopes -- AgainThanks, again, for this!. This Senate minority Report is quite comprehensive, but, other than saying the FDA needs to have more power to make manufacturer's comply, improve communications, data access and sharing, etc., all of which are very important, it only suggests the FDA consider requesting manufacturers modify their scopes so that they can be more effectively decontaminated. No mention is made of a definitive sterilization solution, as one presumes the staff writing the report (it is a quasi-political document) want, of course, to leave any new and real recommendations including mandating terminal sterilization to the FDA.

https://www.help.senate.gov/imo/media/doc/Duodenoscope%20Investigation%20FINAL%20Report.pdf

I
 wonder what discussions TSO3 will be having immediately with the FDA about the data leading to Canadian extended claim in December to terminally sterilize the Olympus TJF-Q180V. This scope is discussed in excellent detail in the Senate report. FDA might want TSO3 to do even more extensive study and accumulate more data on this and other relevant scopes to allow them to make proper and grounded general recommendations. The heat is definitely on the FDA with this somewhat scathing analysis of how they have handled this issue up to the present. FDA officials will be extremely careful going forward, but they will also be clamouring for the VP4 solution to be made official in the US as soon as practically possible, IMHO. 

There remains no other low temperature sterilizer that can compare with the VP4.

WKH
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