3017 EO GAS STERILIZER

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY AND WAS INFORMED THAT THE FACILITY'S EO MONITOR HAD ACTIVATED APPROXIMATELY 10 MINUTES AFTER THE STERILIZER WENT INTO EXHAUST. THE MONITOR ALARMED FOR APPROXIMATELY 20 MINUTES, AFTER WHICH TIME HOSPITAL EMPLOYEES WENT BACK INTO THE DEPARTMENT. THE EO MONITOR IS NOT MANUFACTURED OR MAINTAINED BY STERIS. THE TECHNICIAN EVALUATED THE STERILIZER EXHAUST LINE, CHECK VALVE AND MOISTURE TRAP AS THESE ARE THE POTENTIAL SOURCES FOR AN EO GAS LEAK. THE TECHNICIAN DID NOT IDENTIFY ANY SIGNS OF LEAKING FROM THE STERILIZER. AFTER DISCUSSION WITH THE CUSTOMER, THE EXHAUST LINE, CHECK VALVE AND MOISTURE TRAP WERE PROACTIVELY REPLACED DUE TO THE AGE OF THE COMPONENTS, APPROXIMATELY 18 YEARS OLD. THE EO STERILIZER WAS INSTALLED IN 1996 AND IS NOT CURRENTLY UNDER A STERIS SERVICE CONTRACT. THE UNIT IS MAINTAINED BY THE FACILITY'S BIOMED DEPARTMENT. NO FURTHER ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THEIR EO MONITOR SYSTEM ACTIVATED, ALERTING THE DEPARTMENT OF A POTENTIAL EO GAS LEAK. THE HOSPITAL EMPLOYEES EVACUATED THE DEPARTMENT WHERE THE EO MONITOR AND STERILIZER WERE LOCATED. NO PATIENTS REQUIRED EVACUATION. NO PROCEDURAL DELAYS/CANCELLATIONS OR INJURIES WERE REPORTED WITH THE EVENT.