V-PRO

Description of Event or Problem

THE USER FACILITY REPORTED THAT TWO EMPLOYEES REPORTED BURNS AFTER REMOVING PACKS THAT WERE PROCESSED IN ONE OF THE FACILITY'S TWO V-PRO MAX 2 STERILIZERS. ONE OF THE EMPLOYEES WAS GIVEN OINTMENT AND A TETANUS SHOT.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNITS AND FOUND BOTH UNITS TO BE OPERATING ACCORDING TO SPECIFICATION. NO REPAIRS WERE MADE, AND THE UNITS WERE RETURNED TO SERVICE. IT WAS DISCOVERED THAT BOTH EMPLOYEES WERE NOT WEARING THE PROPER PPE, SPECIFICALLY GLOVES, WHILE HANDLING THE PACKS. THE V-PRO MAX2 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." ADDITIONALLY, THE V-PRO MAX 2 STERILIZER 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." IN-SERVICE TRAINING WAS OFFERED ON THE PROPER USE AND OPERATION OF THE V-PRO MAX 2, SPECIFICALLY THE IMPORTANCE OF WEARING PROPER PPE; HOWEVER, THE USER FACILITY DECLINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.