V-PRO

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE STERILIZERS AND FOUND THE STERILIZERS TO BE OPERATING PROPERLY. NO ISSUES WITH THE FUNCTION OR OPERATION OF THE STERILIZERS WERE IDENTIFIED. NO REPAIRS WERE REQUIRED, AND THE STERILIZERS WERE RETURNED TO SERVICE. THE TECHNICIAN CONFIRMED THAT THE EMPLOYEE WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING THE V-PRO MAX 2 STERILIZERS AS STATED IN THE OPERATOR MANUAL. THE V-PRO MAX 2 STERILIZER OPERATOR MANUAL STATES (6-24), "STERIS RECOMMENDS (IN ACCORDANCE WITH ANSI/AAMI ST58, 2013) WEARING CHEMICAL-RESISTANT GLOVES WHEN USING THE STERILIZATION UNIT." THE V-PRO MAX 2 STERILIZER OPERATOR MANUAL (1-2) 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 ALL INSTRUMENTS ARE PROPERLY DRY PRIOR TO PLACEMENT IN THE V-PRO MAX 2 STERILIZER. THE OPERATOR MANUAL STATES (A-1), "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 WEARING PROPER PPE, SPECIFICALLY GLOVES WHILE OPERATING THEIR V-PRO MAX 2 STERILIZER, AS WELL AS THE IMPORTANCE OF PROPERLY DRYING INSTRUMENTS PRIOR TO PROCESSING. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN ON THEIR FINGERS AFTER HANDLING ITEMS PROCESSED IN THEIR V-PRO MAX 2 STERILIZERS. IT WAS REPORTED MEDICAL TREATMENT WAS ADMINISTERED, BUT THE DETAILS OF THIS TREATMENT WERE NOT PROVIDED.