V-PRO MAX STERILIZER

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE V-PRO MAX STERILIZERS AND FOUND THE UNITS TO BE OPERATING PROPERLY. NO ISSUES WITH THE FUNCTION OR OPERATION OF THE STERILIZERS WERE IDENTIFIED. THE UNITS WERE RETURNED TO SERVICE. IT WAS REPORTED THAT THE EMPLOYEES SUBJECT OF THE REPORTED EVENT WERE NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, AT THE TIME OF THE REPORTED EVENT. THE V-PRO MAX STERILIZER OPERATOR MANUAL STATES (PP. 6-14), "ANSI/AAMI ST58, 2013, RECOMMENDS USING CHEMICAL-RESISTANT GLOVES WHEN USING THE STERILIZATION UNIT." THE V-PRO MAX STERILIZER OPERATOR MANUAL FURTHER (1-2) 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." THE V-PRO MAX STERILIZER OPERATOR MANUAL ALSO STATES, "ALL ITEMS MUST FIRST BE THOROUGHLY CLEANED, RINSED AND DRIED BEFORE BEING PACKAGED AND LOADED INTO THE AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM." STERIS COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE V-PRO MAX STERILIZER, SPECIFICALLY THE IMPORTANCE OF WEARING PROPER PPE WHILE HANDLING INSTRUMENTS THAT HAVE BEEN PROCESSED IN THE STERILIZER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. UDI RELATED DATA CLARIFICATION - THE DEVICES SUBJECT OF THE EVENT WERE MANUFACTURED PRIOR TO UDI COMPLIANCE; THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR.

Description of Event or Problem

THE USER FACILITY REPORTED TWO EMPLOYEES OBTAINED A "BURN" TO THEIR HANDS AFTER UNLOADING THEIR V-PRO MAX STERILIZERS. THE EMPLOYEES SOUGHT MEDICAL TREATMENT; HOWEVER, IT IS UNKNOWN WHAT TYPE OF MEDICAL TREATMENT MAY HAVE BEEN ADMINISTERED.