EO GAS STERILIZER

Description of Event or Problem

THE USER FACILITY REPORTED AN ETO LEAK. NO INJURIES TO HOSPITAL STAFF OR PATIENTS WERE REPORTED. THE DEPARTMENT WAS EVACUATED AND THE FIRE DEPARTMENT WAS DISPATCHED. NO PROCEDURAL DELAYS OR CANCELLATIONS OCCURRED.

Additional Manufacturer Narrative

THE USER FACILITY'S 3RD PARTY TECHNICIAN DETACHED THE EXHAUST MANIFOLD ASSEMBLY FROM THE EO STERILIZER WHILE REPAIRING THE STERILIZER. THE EXHAUST MANIFOLD IS SHARED WITH A SECOND EO STERILIZER, AND WHEN THE SECOND STERILIZER WAS OPERATED, EO GAS LEAKED FROM THE FIRST STERILIZER DUE TO DISCONNECTION OF THE EXHAUST MANIFOLD ASSEMBLY FROM THE FIRST STERILIZER. THE USER FACILITY REQUESTED A STERIS TECHNICIAN TO INSPECT AND ASSESS THE INCIDENT; THE STERIS TECHNICIAN CONFIRMED THAT THE EO STERILIZER WAS CORRECTLY INSTALLED AND OPERATING TO STERIS SPECIFICATIONS. WHEN THE 3RD PARTY TECHNICIAN REMOVED THE EXHAUST MANIFOLD, HE DID NOT FOLLOW THE LOCK OUT/TAG OUT SAFETY PROCEDURES, RESULTING IN THE USER FACILITY OPERATING THE SECOND EO STERILIZER WHICH SHOULD NOT HAVE BEEN OPERATED WHILE THE FIRST UNIT WAS UNDER MAINTENANCE.