V-PRO

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE RECEIVED A BURN ON THEIR HANDS AFTER HANDLING AN INSTRUMENT PACK THAT WAS PROCESSED THEIR V-PRO MAX 2 STERILIZER. THE EMPLOYEE WENT TO THE EMERGENCY ROOM; HOWEVER, IT IS UNKNOWN IF ANY MEDICAL TREATMENT WAS RECEIVED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE STERILIZER AND FOUND THE UNIT TO BE OPERATING PROPERLY. NO ISSUES WITH THE FUNCTION OR THE OPERATION OF THE STERILIZER WERE IDENTIFIED, AND THE STERILIZER WAS RETURNED TO SERVICE. THE EMPLOYEE SUBJECT OF THE REPORTED EVENT WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE HANDLING THE INSTRUMENT PACK. THE V-PRO MAX 2 STERILIZER OPERATOR MANUAL STATES (PG. 35), "ANSI/AAMI ST58, 2013, RECOMMENDS USING CHEMICAL-RESISTANT GLOVES WHEN USING THE STERILIZATION UNIT." THE V-PRO MAX 2 STERILIZER OPERATOR MANUAL (PG. 3) FURTHER 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." THE OPERATOR MANUAL ALSO STATES, (PG.9), "FAILURE TO THOROUGHLY CLEAN, RINSE AND DRY ARTICLES TO BE STERILIZED COULD RESULT IN AN INEFFECTIVE STERILIZATION CYCLE." THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE V-PRO MAX 2 STERILIZER, SPECIFICALLY THE IMPORTANCE OF WEARING PROPER PPE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.