V-PRO

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN AFTER HANDLING ITEMS THAT WERE PROCESSED IN THEIR V-PRO MAX 2 STERILIZERS. THE EMPLOYEE DID NOT SEEK MEDICAL TREATMENT AND CONTINUED WORKING.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE V-PRO MAX 2 STERILIZER AND FOUND THAT THE PRESSURE CALIBRATION VALUES WERE OUT OF ADJUSTMENT AND RECALIBRATED THE TEMPERATURE PROBES AND PRESSURE TRANSDUCERS. THE UNIT WAS TESTED, FOUND TO BE OPERATING ACCORDING TO SPECIFICATION AND WAS RETUNED BACK TO SERVICE. THE TECHNICIAN WAS INFORMED THAT THE EMPLOYEE WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING THE STERILIZERS AS STATED IN THE OPERATOR MANUAL. THE V-PRO MAX 2 STERILIZER OPERATOR MANUAL 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." ADDITIONALLY, 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 STATES (A-1), "A. DRY ALL ITEMS THOROUGHLY. B. ENSURE ALL MOISTURE IS REMOVED FROM ALL INTERNAL PARTS (INCLUDING LUMENS). IF NOT, RESIDUAL HYDROGEN PEROXIDE MAY REMAIN AT CYCLE COMPLETION." USER FACILITY PERSONNEL WERE COUNSELED ON THE IMPORTANCE OF WEARING PROPER PPE, SPECIFICALLY GLOVES, AS WELL AS PROPERLY DRYING INSTRUMENTS PRIOR TO PROCESSING. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.