GREY:TSTIF - Post by User
Comment by
Darrow100on Mar 13, 2018 1:41pm
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Post# 27707831
RE:RE:RE:RE:RE:RE:RE:RE:RE:FDA warns duodenoscope manufacturers about failure to comply
RE:RE:RE:RE:RE:RE:RE:RE:RE:FDA warns duodenoscope manufacturers about failure to complyYes isn't it funny?
The 3 largest scope manufacturers get a letter stating that they have not complied with the FDA's request of some three years ago about problems with unclean (to put it mildly) scopes.
And what's the penalty - well another request for the required documentation !!
Meanwhile the company that has the equipment that they have proven to other juristrictions - Canada and Europe - that they can indeed sterilize these scopes have problems getting FDA approval for duodenoscopes and so the SP Tanks.
Face it folks this isn't a technical/compliance problem with the VP4 it is simply the FDA playing politics and nothing more.
However it has had serious consequenses for TSO3.
I have watched this movie before some years ago before with another small Canadian company in the health care field.