GENERAL HOSPITL PLASMA TAZZ

Description of Event or Problem

NO IFU FOR THIS PRODUCT, ALL THEY WILL GIVE IS ATTACHED PAGE CALLING OUT BRANDS, BUT ZERO CYCLES AND NO MATERIAL COMPATIBILITY. ACCESS GUDID HAS ZERO INFORMATION NEITHER ¿ HOW IS THIS ALLOWED. STERILE PROCESSING NEEDS IFU, IT IS STANDARD. THIS PRODUCT HAS NO IFU ¿ ONLY A BROCHURE THAT SAYS PRODUCT NAMES OF STERILIZERS BUT ZERO CYCLE INFORMATION. SAYS HAS MATERIAL COMPATIBILITY BUT DOES NOT SAY WHAT, AND BOTH STERRAD AND VPRO ARE VERY DIFFERENT. THIS IS A PATIENT SAFETY ISSUE IF STERILE PROCESSING DEPARTMENTS DO ZERO USE, THIS SITES PATIENTS CAN HAVE INFECTIONS.