GREY:TSTIF - Post by User
Comment by
echo2on Jun 23, 2017 1:04pm
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Post# 26398532
RE:As much as I want to understand the notice from FDA ...
RE:As much as I want to understand the notice from FDA ...Previous regulation only required 'cleaning and disinfection' protocols and validation as part of the 510K process for a new or modified scope.
The addition of 'sterilization' changes the playing field completely going forward. And, TSO3 makes and supplies all the balls to all the teams and players, (unless you want to include 3M's ETO beachball).
Of course, all three of these components will be part of any ongoing protocols for scope use for now, though sterilization will be soon recognized as a robust valid replacement for and allow the deletion of (many, most, all?) disinfection protocols (HLD), I expect. One step at a time. Cleaning will, of course, always remain an essential component of any protocols preparing scopes for patient use.