V-PRO MAX 2 STERILIZER

Additional Manufacturer Narrative

THE CELERITY 20 HP BIOLOGICAL INDICATOR HAD BEEN PROCESSED IN A V-PRO MAX 2 STERILIZER. FOLLOWING A COMPLETED CYCLE, THE EMPLOYEE PROCEEDED TO PICK UP THE INDICATOR AND FELT A BURNING SENSATION ON THEIR HANDS. THE EMPLOYEE SUBJECT OF THE REPORTED EVENT WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES WHILE HANDLING THE BIOLOGICAL INDICATOR. THE INSTRUCTIONS FOR USE STATES, "CAUTION: CHALLENGE PACKS AND TEST CONFIGURATIONS PROCESSED THROUGH VAPORIZED HYDROGEN PEROXIDE STERILIZATION MAY CONTAIN RESIDUAL HYDROGEN PEROXIDE. ALWAYS WEAR GLOVES WHEN HANDLING THE BI." "RESIDUAL HYDROGEN PEROXIDE MAY BE TRAPPED WITHIN THE CAP IF THE BI IS DAMAGED. AVOID DIRECT CONTACT WITH THE BI AND ITS CONTENTS, AS IT MAY RESULT IN A HYDROGEN PEROXIDE CHEMICAL BURN. PLACE THE ENTIRE TEST POUCH AND ITS CONTENTS INTO A STEAM COMPATIBLE CONTAINER AND FOLLOW THE INSTRUCTIONS FOR DISPOSAL PROVIDED BELOW." A STERIS SALES REPRESENTATIVE PROVIDED IN-SERVICE TRAINING MATERIALS TO THE USER FACILITY ON THE PROPER USE AND HANDLING OF THE CELERITY 20 HP BIOLOGICAL INDICATOR AND WAS COMPLETED IN FEBRUARY OF 2024. THE DEVICE HISTORY RECORD FOR THE SUBJECT LOT WAS REVIEWED AND NO ABNORMALITIES WERE FOUND. A STERIS TECHNICIAN WILL CONTACT THE CUSTOMER TO SCHEDULE AN INSPECTION OF THEIR V-PRO MAX 2 STERILIZER. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A "BURN" AFTER HANDLING THEIR CELERITY 20 HP BIOLOGICAL INDICATOR. IT HAS BEEN REPORTED MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE V-PRO MAX 2 STERILIZER AND FOUND THE UNIT TO BE OPERATING PROPERLY. NO ISSUE WITH THE FUNCTION OR OPERATION OF THE STERILIZER WAS IDENTIFIED AND THE STERILIZER WAS RETURNED TO SERVICE. BASED ON THE DESCRIPTION OF THE EVENT, THE BI WAS LIKELY DAMAGED PRIOR TO THE CYCLE ALLOWING HYDROGEN PEROXIDE TO BECOME TRAPPED AND REMAIN AFTER THE CYCLE SUBSEQUENTLY CAUSING THE REPORTED EVENT TO OCCUR. THE BI MEDIA IS WATER-BASED AND NON-TOXIC. THE REPORTED BURN IS ATTRIBUTED TO THE EMPLOYEE NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING THEIR V-PRO MAX 2 STERILIZER. THE V-PRO MAX 2 STERILIZER OPERATOR MANUAL (3) STATES, "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." A STERIS SALES REPRESENTATIVE PROVIDED IN-SERVICE TRAINING MATERIALS TO THE USER FACILITY ON THE PROPER USE AND HANDLING OF THE CELERITY 20 HP BIOLOGICAL INDICATOR. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.