ACUSON FREESTYLE

Description of Event or Problem

SIEMENS HEALTHINEERS MANUFACTURERS A PRODUCT CALLED THE ACUSON FREESTYLE. WITHIN THE USER MANUAL/IFU FOR THIS PRODUCT (HTTPS://DOCLIB.SIEMENS-HEALTHINEERS.COM/REST/V1/VIEW?DOCUMENT-ID=1094261), IT STATES ON PAGE 2-30 THAT PROBES HAVE BEEN DESIGNED AND TESTED TO BE ABLE TO WITHSTAND HIGH LEVEL DISINFECTION. UNDER THE PROBE HIGH LEVEL DISINFECTION SECTION ON PAGE 2-32, THE INSTRUCTION SAY TO SOAK THE PROBE USING A COMPATIBLE DISINFECTANT LISTED BELOW. IN THE TABLE PROVIDED ON PAGE 2-33, THERE ARE NO HIGH-LEVEL DISINFECTANTS LISTED AND THERE ARE NO HIGH-LEVEL DISINFECTANTS LISTED ANYWHERE ELSE IN THE IFU. I REACHED OUT TO SIEMENS HEALTHINEERS FOR CLARIFICATION ON APPROVED HIGH-LEVEL DISINFECTANTS AND WAS TOLD THAT SINCE WE DO NOT HAVE AN ACTIVE CONTRACT WITH THEM, THAT WE WOULD HAVE TO OPEN A PURCHASE ORDER AND PAY AN UNKNOWN AMOUNT TO GET THIS INFORMATION. THEY SAID THAT THIS WAS THE ONLY OPTION AND THAT THEY WOULD NOT BE ABLE TO SUPPORT US WITHOUT OPENING A PURCHASE ORDER AND PAYING THEM MONEY. WITHOUT THIS INFORMATION WE ARE UNABLE TO PROPERLY PROCESS THE L8-3 AND L17-5 ULTRASOUND PROBES THAT MEET SEMI-CRITICAL AND CRITICAL SPAULDING CLASSIFICATIONS, WHICH LIMITS OUR ABILITY TO USE THESE PRODUCTS AND PROVIDE SAFE PATIENT CARE.