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第七章 PowerPoint PPT Presentation


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第七章. 臨床工程. 7.1  前言. 「臨床工程師」 (clinical engineer) 一詞,最早於 1970 年代初期由美國醫療儀器促進協會 (Association of Advancement of Medical Instrumentation, AAMI) 主席 Cesar Caceres 醫師所提出。

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第七章

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3792162


3792162

7.1

  • (clinical engineer) 1970(Association of Advancement of Medical Instrumentation, AAMI) Cesar Caceres

  • 1973(biomedical equipment technician, BMET) 1(radiation equipment specialist, RES) (laboratory equipment specialist, LES)


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  • ACCE

  • ICC

    /

  • AAMI


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    • (technology management)

    • (quality assurance)

    • (risk management)

    • (technology assessment)

    • (training and R&D)

    • (compliance with regulations and standards)


7 2 1

7.2.1


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  • (technology management) (strategic planning) (technology assessment) (need assessment) (acquisition evaluation) (technology utilization) (technology support) (quality and risk management) (resource management)


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7 2 2

7.2.2


7 3 1

7.3.1


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    • ()


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  • (maintainability)

  • (compatibility)

  • (availability)


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    • (ergonomics) (human factors)


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    • ()


7 3 2

7.3.2

    • ()


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    • ()

    • () ()

    • ()

    • (performance verification)


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  • (commissioning) (performance verification)


7 3 3

7.3.3

  • (repair or corrective maintenance, CM) (demand maintenance, DM) (unscheduled maintenance) (failure) (performance verification)


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  • (malfunction)

    (1)

    (2)

    (3)()

    (4)


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    • (downtime)

    • ()


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    • ()

    • ()


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  • (1) (downtime)

    (2)

    (3)

    (4)

    (5)


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    • (electromedical equipments)


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7 3 4

7.3.4


External service

(external service)

    • (full service) ()

    • (partial parts and labor)

    • (parts only)

    • (labor)

    • (time and materials)

    • (preventive maintenance)

    • (repair service)

    • (shared service)


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    • (travel time)


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  • ()

  • ()


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    • ()


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7.4

  • (safety) (effectiveness) (usability) (reliability)


7 4 1

7.4.1

1.

  • (continuous quality improvement, CQI ) CQI

    (1) (structure)

    (2) (process)

    (3) (outcome-based)


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2.

  • CQI (key performance indicators, KPI) CQI (functions) () (KPI)


7 4 2

7.4.2

1.

  • ISO 14971

  • (harm) (potential sources) (hazard) (severity)(probability) (risk = severityprobability)


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  • (risk assessment) [ (risk estimation) (risk evaluation) ] (risk control)


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2. (hazard report management)

  • (1)

    (2)

    (3)

    (4)


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3. (incident investigation)

    • () (adverse affect)


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4.

  • (adverse events)


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7 5 1

7.5.1


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  • (coordinator) (primary investigator)


7 5 2

7.5.2

  • (micro shock) (macro shock)


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7 6 1

7.6.1

  • (evaluation) (assessment)

  • (cost-benefit) (cost-effectiveness)


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  • (1) (feasibility) ()

    (2) (efficacy) ()

    (3) (effectiveness) ()

    (4) (economic benefit)


7 6 2

7.6.2


7 7 1

7.7.1

  • (regulation) (standard) (technical guidance)


7 7 2

7.7.2


7 7 3

7.7.3


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7.8


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