VPRO MAX DOUBLE DOOR REC, 400V 50/60HZ (ENGLISH)

Additional Manufacturer Narrative

FOLLOWING THE REPORTED EVENT, THE USER FACILITY BIOMED INSPECTED THE V-PRO MAX STERILIZER AND DID NOT FIND ANY ISSUES WITH THE FUNCTION OR OPERATION. THE STERILIZER WAS RETURNED TO SERVICE WITH NO REPAIRS REQUIRED. IT WAS LEARNED THE EMPLOYEE WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, AT THE TIME OF THE REPORTED EVENT. THE V-PRO MAX STERILIZER OPERATOR MANUAL STATES (6-14), "ANSI/AAMI ST58, 2013, RECOMMENDS USING CHEMICAL-RESISTANT GLOVES WHEN USING THE STERILIZATION UNIT. THE V-PRO MAX STERILIZER OPERATOR MANUAL (1-2) FURTHER STATES, "DANGER - CHEMICAL INJURY HAZARD: ANY VISIBLE LIQUIDS IN THE CHAMBER OR ON THE LOAD MUST BE TREATED AS CONCENTRATED HYDROGEN PEROXIDE. OBSERVE ALL HYDROGEN PEROXIDE HANDLING PRECAUTIONS. WHEN HANDLING HYDROGEN PEROXIDE, WEAR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT." ADDITIONALLY, USER FACILITY PERSONNEL SHOULD ENSURE THAT INSTRUMENTS ARE PROPERLY DRIED PRIOR TO PLACEMENT IN THE V-PRO MAX STERILIZER. THE V-PRO MAX STERILIZER OPERATOR MANUAL (A-1) STATES, "DRY ALL ITEMS THOROUGHLY. ENSURE ALL MOISTURE IS REMOVED FROM ALL INTERNAL PARTS (INCLUDING LUMENS). IF NOT, RESIDUAL HYDROGEN PEROXIDE MAY REMAIN AT CYCLE COMPLETION AND/OR A CYCLE ABORT OCCURS. ONLY DRY ITEMS ARE TO BE PLACED IN STERILIZATION UNIT." STERIS COUNSELED THE USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE V-PRO MAX STERILIZER, SPECIFICALLY TO ENSURE ALL INSTRUMENTS ARE PROPERLY DRIED BEFORE PROCESSING AND TO WEAR PROPER PPE WHILE HANDLING INSTRUMENTS TO THE STERILIZER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED AN EMPLOYEE OBTAINED A BURN TO THEIR FINGERS WHILE HANDLING ITEMS PROCESSED IN THEIR V-PRO MAX STERILIZER. THE EMPLOYEE RINSED THEIR HANDS WITH WATER FOLLOWING THE REPORTED EVENT. MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED (OINTMENT). THE EMPLOYEE RETURNED TO WORK TWO DAYS AFTER THE EVENT.