BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 3305922 · Received August 23, 2013

    Report

    Report Number
    3000251274-2013-00073
    Date Received
    August 23, 2013
    Date of Event
    July 19, 2013
    Report Date
    August 23, 2013
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REQUESTED THAT STERIS INSPECT THEIR SYSTEM 1E PROCESSOR AND CONDUCT IN-SERVICE TRAINING. A STERIS SERVICE TECHNICIAN INSPECTED THE SYSTEM 1E UNIT AND FOUND IT TO BE OPERATING PROPERLY; NO ISSUES WERE NOTED. PER THE USER FACILITY'S REQUEST, THE A&B PRE-FILTERS WERE REPLACED AND A NEW ASPIRATOR PROBE WAS INSTALLED. IN ADDITION, A STERIS CLINICAL EDUCATION SPECIALIST VISITED THE FACILITY TO DISCUSS THE REPORTED EVENT AND CONDUCT IN-SERVICE TRAINING. THE USER FACILITY REPORTED THAT IT WAS NOT MANUALLY PRE-CLEANING ENDOSCOPES PRIOR TO PROCESSING THEM IN SYSTEM 1E. THIS IS CONTRARY TO PUBLISHED CLINICAL GUIDELINES, AS WELL AS ENDOSCOPE MANUFACTURERS' INSTRUCTIONS FOR USE, WHICH MANDATE POINT-OF-USE, BEDSIDE PRE-CLEANING AFTER USE AS WELL AS THOROUGH MANUAL CLEANING PRIOR TO STERILIZATION OR HIGH LEVEL DISINFECTION (REFERENCES: ANSI/AAMMI ST-79: 2010, AAMI TIR-12: 2011, CDC GUIDELINE FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES: 2011, MULTISOCIETY GUIDELINE ON REPROCESSING FLEXIBLE GASTROINTESTINAL ENDOSCOPES: 2011). IN ADDITION, THE SYSTEM 1E OPERATOR MANUAL STATES (PP. 5-2): "WARNING FAILURE TO THOROUGHLY CLEAN DEVICES, ENDOSCOPES, ETC., MAY RESULT IN INEFFECTIVE LIQUID CHEMICAL STERILIZATION. WARNING: ADEQUATE CLEANING OF THE MEDICAL DEVICE IS REQUIRED. RESIDUAL PATIENT SOIL OR OTHER MATERIAL OR CLEANING AGENTS MAY DECREASE EFFECTIVENESS OF S40 STERILANT CONCENTRATE". THE SYSTEM 1E OPERATOR MANUAL STATES (PP. 7-14): "DEVICES NOT USED IMMEDIATELY MUST BE LIQUID CHEMICALLY RE-STERILIZED PRIOR TO PATIENT USE." STERIS WAS UNABLE TO DETERMINE DURING ITS INVESTIGATION HOW LONG AFTER PROCESSING THE USER FACILITY SAMPLED THE ENDOSCOPE OR IF AN ADEQUATE ASEPTIC HANDLING TECHNIQUE WAS EMPLOYED DURING SAMPLING. THE STERIS CLINICAL EDUCATION SPECIALIST CONDUCTED IN-SERVICE TRAINING ON (B)(6) 2013 ON THE PROPER USE AND OPERATION OF THE SYSTEM 1E AND THE IMPORTANCE OF PRE-CLEANING DEVICES BEFORE PROCESSING IN THE SYSTEM 1E.

    Description of Event or Problem · 1

    THE USER FACILITY (A MAXIMUM SECURITY STATE PRISON) REPORTED THAT RANDOM TESTING OF AN ENDOSCOPE THAT HAD BEEN PROCESSED IN THEIR SYSTEM 1E TESTED POSITIVE FOR E COLI. NO INJURIES WERE REPORTED OR ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413005 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other