V-PRO 1 PLUS STERILIZER

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE V-PRO 1 PLUS STERILIZER AND FOUND THE UNIT TO BE OPERATING PROPERLY. NO REPAIRS WERE REQUIRED AND THE UNIT WAS RETURNED TO SERVICE. THE TECHNICIAN WAS INFORMED THAT THE EMPLOYEE WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES AS STATED IN THE OPERATOR MANUAL. THE V-PRO 1 PLUS STERILIZER OPERATOR MANUAL STATES (6-11), "STERIS RECOMMENDS (IN ACCORDANCE WITH ANSI/AAMI ST58, 2005) WEARING CHEMICAL-RESISTANT GLOVES WHEN USING THE STERILIZATION UNIT." THE OPERATOR MANUAL FURTHER STATES (1-2), "DANGER - CHEMICAL INJURY HAZARD: ANY VISIBLE LIQUIDS IN THE CHAMBER 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 ALL INSTRUMENTS ARE PROPERLY DRY PRIOR TO PLACEMENT IN THE V-PRO 1 PLUS STERILIZER. THE V-PRO 1 PLUS OPERATOR MANUAL STATES (A-1), "A. DRY ALL ITEMS THOROUGHLY. B. ENSURE ALL MOISTURE IS REMOVED FROM ALL INTERNAL PARTS (INCLUDING LUMENS). C. ONLY DRY ITEMS ARE TO BE PLACED IN STERILIZATION UNIT." THE TECHNICIAN COUNSELED THE USER FACILITY ON THE IMPORTANCE OF WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING THEIR V-PRO 1 PLUS STERILIZER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED AN EMPLOYEE EXPERIENCED A BURN ON THEIR ARM WHILE HANDLING ITEMS THAT WERE PROCESSED IN THEIR V-PRO 1 PLUS STERILIZER. THE EMPLOYEE SOUGHT MEDICAL TREATMENT AT THE FACILITY'S ER AND RETURNED TO WORK.