3017 ETO STERILIZER

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN ETHYLENE OXIDE ALARM WENT OFF WHEN AN EMPLOYEE OPENED THE STERILIZER DOOR, ALLOWING ETHYLENE OXIDE GAS TO BE RELEASED FROM THE STERILIZER. THE STERILIZER WAS IN THE PROCESS OF BEING SERVICED BY A STERIS SERVICE TECHNICIAN AND HAD BEEN PLACED INTO SERVICE MODE AND TAGGED AS 'DO NOT USE' AT THE TIME OF THIS EVENT. THREE FACILITY EMPLOYEES WERE IN THE AREA OF THE STERILIZER WHEN THE DOOR WAS OPENED. TWO EMPLOYEES REPORTED TO THE FACILITY EMERGENCY ROOM FOR HEADACHES, ITCHING, IRRITATED THROAT, AND ONE EMPLOYEE EXPERIENCED HIGH BLOOD PRESSURE. A THIRD EMPLOYEE REPORTED TO THE FACILITY EMPLOYEE HEALTH DEPARTMENT FOR A HEADACHE. TWO OF THE EMPLOYEES DID NOT RECEIVE ANY MEDICAL TREATMENT AS A RESULT OF THEIR REPORTED SYMPTOMS. ONE OF THE EMPLOYEES FOLLOWED UP WITH HER FAMILY PHYSICIAN AFTER THE REPORTED EVENT AND WAS GIVEN TYLENOL. THE FACILITY REPORTED ALL THREE EMPLOYEES ARE FULLY RECOVERED WITH NO SUSTAINING INJURIES.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN WAS INITIALLY ONSITE TO SERVICE ANOTHER STERILIZER WHEN HE WAS NOTIFIED BY A HOSPITAL EMPLOYEE THAT THE STERILIZER INVOLVED IN THIS EVENT WAS NOT OPERATING PROPERLY. UPON INSPECTION, THE TECHNICIAN NOTED THAT AN AIR PRESSURE VALVE WAS SET TOO HIGH AND THE UNIT WAS OUT OF PRINTER PAPER. THE TECHNICIAN PUT THE STERILIZER INTO SERVICE MODE AND TAGGED IT AS "DO NOT USE" AND LEFT THE STERILIZER ROOM MOMENTARILY. WHEN THE TECHNICIAN LEFT THE STERILIZER ROOM, USER FACILITY EMPLOYEES OPENED THE DOOR WITH A NON-AERATED LOAD INSIDE. WHEN THE TECHNICIAN RETURNED, HE ALLOWED THE UNIT TO AERATE OVERNIGHT, ADJUSTED THE UNIT'S AIR PRESSURE VALVE, REPLACED THE UNIT'S PRINTER PAPER, ADJUSTED THE UNIT'S RETRACT AND EXTEND SWITCHES, TESTED THE UNIT RETURNING IT TO SERVICE. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THE EQUIPMENT. STERIS HAS DETERMINED THE CAUSE OF THIS EVENT TO BE USER ERROR AS THE TECHNICIAN TAGGED THE UNIT AS "DO NOT USE" AND PUT IT INTO SERVICE MODE PRIOR TO CONDUCTING SERVICE ON THE UNIT. THE TECHNICIAN ALSO VERBALLY NOTIFIED FACILITY BIOMEDICAL PERSONNEL AND TWO OF THE FACILITY EMPLOYEES THAT WERE LATER INJURED NOT TO USE THE STERILIZER. PAGE 6-12 FURTHER WARNS USERS "DO NOT OPEN THE STERILIZER DOOR BEFORE FULL AERATION IS COMPLETED WITHOUT FOLLOWING THE 'PAUSING AERATION' PROCEDURE." STERIS SCHEDULED REFRESHER IN-SERVICE TRAINING REGARDING THE PROPER USE AND OPERATION OF THE STERILIZER FOR (B)(4) 2010.