V-PRO

Description of Event or Problem

THE USER FACILITY REPORTED THAT EMPLOYEES OBTAINED "WHITE STAINING" TO THEIR FINGERS WHILE UNLOADING INSTRUMENTS PROCESSED IN THEIR V-PRO MAX 2 STERILIZER. THE EMPLOYEES CONTINUED WORKING. NO REPORT OF INJURY. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE V-PRO MAX 2 STERILIZER AND FOUND THE PRESSURE TRANSDUCER REQUIRED RECALIBRATION AND TWO VALVES REQUIRED REPLACEMENT. THE TECHNICIAN RECALIBRATED THE PRESSURE TRANSDUCER AND MADE THE NECESSARY REPLACEMENTS, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. THE TECHNICIAN WAS INFORMED THAT THE EMPLOYEES WERE NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING THE STERILIZER. THE V-PRO MAX 2 STERILIZER OPERATOR MANUAL 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." THE OPERATOR MANUAL FURTHER STATES, "ANSI/AAMI ST58, 2013, RECOMMENDS USING CHEMICAL-RESISTANT GLOVES WHEN USING THE STERILIZATION UNIT." ADDITIONALLY, USER FACILITY PERSONNEL SHOULD ENSURE ALL INSTRUMENTS ARE PROPERLY DRY PRIOR TO PLACEMENT IN THE V-PRO MAX 2 STERILIZER. THE OPERATOR MANUAL 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." THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE IMPORTANCE OF WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING THEIR V-PRO MAX 2 STERILIZER AND PROPERLY DRYING INSTRUMENTS PRIOR TO PROCESSING. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.