AMSCO V-PRO

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN AFTER HANDING INSTRUMENTS THAT WERE PROCESSED IN THEIR V-PRO MAX STERILIZER. THE EMPLOYEE SOUGHT MEDICAL TREATMENT; THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS ADMINISTERED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THE UNIT TO BE OPERATING PROPERLY. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. NO REPAIRS WERE MADE. WHILE ONSITE, STERIS WAS INFORMED THAT THE EMPLOYEE WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING THE STERILIZER. THE V-PRO MAX STERILIZER OPERATOR MANUAL STATES (1-2), "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 V-PRO MAX OPERATOR MANUAL, (A-1) FURTHER 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." WHILE ONSITE THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE IMPORTANCE OF WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING THEIR V-PRO MAX STERILIZER AND PROPERLY DRYING INSTRUMENTS PRIOR TO PROCESSING. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.