V-PRO

Description of Event or Problem

THE USER FACILITY REPORTED AN EMPLOYEE OBTAINED A BURN TO THEIR FINGERS WHILE HANDLING ITEMS PROCESSED IN THEIR V-PRO MAX 2 STERILIZER. THE EMPLOYEE RINSED THEIR HANDS FOLLOWING THE REPORTED EVENT. NO MEDICAL TREATMENT WAS SOUGHT; HOWEVER, THE EMPLOYEE DID PLACE OINTMENT ON THEIR FINGERS AND RETURNED TO WORK.

Additional Manufacturer Narrative

A SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE V-PRO MAX 2 STERILIZER AND FOUND THE UNIT TO BE OPERATING PROPERLY. NO ISSUES WITH THE FUNCTION OR OPERATION OF THE STERILIZER WERE IDENTIFIED. THE UNIT WAS THEN RETURNED TO SERVICE. IT WAS LEARNED THE EMPLOYEE WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, AT THE TIME OF THE REPORTED EVENT. USER FACILITY PERSONNEL SHOULD ENSURE ALL INSTRUMENTS ARE PROPERLY DRY PRIOR TO PLACEMENT IN THE V-PRO MAX 2 STERILIZER. THE V-PRO MAX 2 STERILIZER OPERATOR MANUAL, (A-1) 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 V-PRO MAX 2 STERILIZER OPERATOR MANUAL ADDITIONALLY STATES (6-16), "STERIS RECOMMENDS (IN ACCORDANCE WITH ANSI/AAMI GUIDELINES) 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 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." STERIS COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE V-PRO MAX 2 STERILIZER, SPECIFICALLY TO ENSURE ALL INSTRUMENTS ARE PROPERLY DRIED BEFORE PROCESSING. STERIS WILL OFFER ADDITIONAL COUNSELING TO THE USER FACILITY PERSONNEL, SPECIFICALLY IN WEARING PROPER PPE WHILE HANDLING INSTRUMENTS TO THEIR V-PRO MAX 2 STERILIZER. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

A STERIS ACCOUNT MANAGER CONDUCTED IN-SERVICE TRAINING WITH USER FACILITY PERSONNEL ON THE IMPORTANCE OF WEARING PROPER PPE WHILE HANDLING INSTRUMENTS THAT HAVE BEEN PROCESSED IN THEIR V-PRO MAX 2 STERILIZER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.