GREY:TSTIF - Post by User
Comment by
echo2on Jun 23, 2017 12:39pm
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Post# 26398377
RE:The Most Significant News FDA Has Ever Released re:TOS!!
RE:The Most Significant News FDA Has Ever Released re:TOS!!OK. Instead of "ALL HOSPITALS, GI SUITES, OR HEALTH CARE PROVIDERS WILL BE OBLIGED TO RECOGNIZE THE NECESSITY OF HAVING A VP4 (OR 2 OR 6 OF THEM) IN THEIR FACILITY TO STERILIZE SCOPES FROM AUGUST ONWARD."
I should have said, "ALL HOSPITALS, GI SUITES, OR HEALTH CARE PROVIDERS WILL BE OBLIGED TO RECOGNIZE THE NECESSITY FOR ALL FUTURE NEW OR MODIFIED SCOPES OF HAVING A VP4 (OR 2 OR 6 OF THEM) IN IN THEIR FACILITY TO STERILIZE THESE SCOPES FROM AUGUST ONWARD." AND, IT WOULDN'T HURT, ESPECIALLY FROM PATIENT CARE, SAFETY, EFFICIENCY, AND LIABILITY STANDPOINTS, TO HAVE A FEW VP4'S IN USE FROM NOW ON IN ONE'S FACILITY TO STERILIZE EXISTING GRANDFATHERED SCOPES, NEARLY ALL OF WHICH ARE INCLUDED IN ONE OF TSO3'S COMPATIBILITY MATRICES ALREADY.
IT SEEMS THAT EVEN SOME ANALYSTS COVERING TSO3 DON'T SEEM TO REALIZE THAT PREVIOUSLY THERE WAS NO REGULATION REQUIRING STERILIZATION VALIDATION FOR SCOPES TO GET FDA 510K APPROVAL, ONLY CLEANING AND DISINFECTION PROTOCOLS.
THIS IS A GAME CHANGER, AS TSO3'S VP4 IS THE ONLY LOW TEMPERATURE STERILIZER (apart from the impractical, inefficient, and very toxic ETO units installed in some hospitals) THAT CAN VALIDATE NEW OR MODIFIED SCOPES SEEKING FDA APPROVAL.
:)