3017 ETO STERILIZER

Description of Event or Problem

THE USER FACILITY REPORTED THAT WHEN OPERATORS REMOVED THE ETHYLENE OXIDE CANISTERS AFTER THE STERILIZER CYCLES ABORTED DUE TO "NO GAS" ALARMS, LIQUID REMAINED IN THE CANISTERS. TWO EMPLOYEES WENT TO THE EMERGENCY ROOM FOR ETHYLENE OXIDE EXPOSURE ASSESSMENT, HOWEVER NO TREATMENT WAS ADMINISTERED. THE EMPLOYEES RETURNED TO WORK AND ARE FINE WITH NO SUSTAINING INJURIES.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN INSPECTED THE STERILIZER AND FOUND THAT THE PUNCTURE PIN WAS BROKEN. HE REPLACED THE PUNCTURE CYLINDER AND PIN PUNCTURE. THE STERILIZER WAS RETURNED TO SERVICE; NO FURTHER ISSUES HAVE BEEN REPORTED. THE CAUSE OF THE STERILIZER ALARMS WAS DUE TO IMPROPER INSTALLATION OF THE ETHYLENE OXIDE CANISTERS. THE OPERATOR MANUAL STATES (PP.6-4), "THE EO CARTRIDGE IS TO BE INSTALLED INTO THE STERILIZER CHAMBER RECESS LOCATED INSIDE THE CHAMBER AT THE FRONT LEFT SIDE". THE OPERATOR MANUAL FURTHER STATES, "ENSURE THE CARTRIDGE IS FULLY SEATED. FAILURE TO SEAT THE CARTRIDGE COMPLETELY MAY CAUSE AN INCOMPLETE CARTRIDGE PUNCTURE". THE CANISTERS WERE NOT PROPERLY ALIGNED WHEN INSERTED, CAUSING AN INCOMPLETE PUNCTURE AND ALSO THE PUNCTURE PIN TO BREAK. THE STERILIZER IS UNDER STERIS MAINTENANCE CONTRACT AND WAS LAST SERVICED ON (B)(6) 2011 WHEN NO ISSUES WERE NOTED WITH THE STERILIZER. STERIS CONDUCTED IN-SERVICE TRAINING REGARDING PROPER USE AND OPERATION OF THE EQUIPMENT ON (B)(4) 2011.