Thanks Terry for your interesting story and your bet, it's almost impossible to see clearly in this situation. Most are focused on the FDA as salvation, perhaps so.
As several have pointed out, why is the FDA now involved since there is no patient contact with the AS process? True, but there is contact with life-saving equipment. Hoping to make a splash, MZEI advertised the total disinfection of operating theaters, but they did this without appreciating that higher order regs applied. They should have stuck with patient rooms, then applied for ORs later.
