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    BME-02 Initial Testing and Evaluation

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    PAPPU RANJITH KUMAR
    This document outlines a policy for inspecting and testing biomedical equipment before its initial use at Maxcure Hospitals in Hyderabad. All biomedical equipment, regardless of ownership, must pass inspection by the biomedical engineering department which includes checking for proper operation, safety, and inclusion in the equipment management program. The biomedical engineer is responsible for inspecting, documenting, and affixing identification to equipment that passes. Equipment failing inspection will be prohibited from use and returned to its source.

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    BME-02 Initial Testing and Evaluation

    Uploaded by

    PAPPU RANJITH KUMAR
    247 views2 pages
    This document outlines a policy for inspecting and testing biomedical equipment before its initial use at Maxcure Hospitals in Hyderabad. All biomedical equipment, regardless of ownership, must pass inspection by the biomedical engineering department which includes checking for proper operation, safety, and inclusion in the equipment management program. The biomedical engineer is responsible for inspecting, documenting, and affixing identification to equipment that passes. Equipment failing inspection will be prohibited from use and returned to its source.

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    This document outlines a policy for inspecting and testing biomedical equipment before its initial use at Maxcure Hospitals in Hyderabad. All biomedical equipment, regardless of ownership, must pass inspection by the biomedical engineering department which includes checking for proper operation, safety, and inclusion in the equipment management program. The biomedical engineer is responsible for inspecting, documenting, and affixing identification to equipment that passes. Equipment failing inspection will be prohibited from use and returned to its source.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    247 views2 pages

    BME-02 Initial Testing and Evaluation

    Uploaded by

    PAPPU RANJITH KUMAR
    This document outlines a policy for inspecting and testing biomedical equipment before its initial use at Maxcure Hospitals in Hyderabad. All biomedical equipment, regardless of ownership, must pass inspection by the biomedical engineering department which includes checking for proper operation, safety, and inclusion in the equipment management program. The biomedical engineer is responsible for inspecting, documenting, and affixing identification to equipment that passes. Equipment failing inspection will be prohibited from use and returned to its source.

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    of 2

    SOP/MC/BME-02

    MAXCURE HOSPITALS HYDERABAD


    Issue No.
    Initial Testing and Evaluation Date: 15/05/2015
    Page No. 1 of 5

    PREPARED BY: BIOMEDICAL ENGINEERING DEPT APPROVED BY:

    1.0 Purpose:

    To assure that all Biomedical equipment is inspected prior to its initial use.

    2.0 Policy

    All Biomedical equipment coming into the hospital is tested before initial use and appropriately added
    to an inventory. These tests, evaluations and inventories are documented. All Biomedical equipment
    falling under the responsibility of the Biomedical engineering department is covered by this policy,
    regardless of ownership, and must pass the incoming inspection before it will be allowed into the
    hospital. Examples of ownership categories are:

    • Rental/leased equipment
    • Physician-owned equipment
    • Donated/loaned equipment
    • Hospital-owned equipment

    3.0 Abbreviations/Definitions/Keywords
    4.0 Responsibility:

    Biomedical engineer and the operative / User department shall be responsible for inspection,
    coordinating & documentation

    5.0 Internal customers: Clinical, Laboratory, Operation Theatres, Imaging Services Departments and
    other departments
    6.0 Procedures
    A. Hospital-owned equipment:

    1. When notified that new biomedical equipment is received in the hospital, the Biomedical Engineering
    department will initiate a work order.
    2. The Biomedical engineering department will ensure that the new equipment is inspected for:
    a. Presence of all accessories required for proper operation.
    b. Presence of operators’ manuals and technical service manuals, and schematics, if applicable.
    c. Proper operation of the equipment. Performance specifications in the Manufacturer’s service
    literature should be used if available.
    d. Biomedical alarm functionality and audibility, if applicable.
    e. Passage of electrical safety requirements, if applicable.
    f. Inclusion into, or exclusion from, the equipment management programme.
    g. Compliance on labeling of equipment, to ensure that the equipment has been evaluated for safety
    and suitability for intended use.
    SOP/MC/BME-02
    MAXCURE HOSPITALS HYDERABAD
    Issue No.
    Initial Testing and Evaluation Date: 15/05/2015
    Page No. 2 of 5

    PREPARED BY: BIOMEDICAL ENGINEERING DEPT APPROVED BY:

    3. If equipment passes all required inspections, the Engineer will affix a Biomedical Equipment
    maintenance inspection sticker, or other means of identification, in a visible location on the device.

    4. The Biomedical engineer who performs the inspection is responsible for ensuring the completion of
    the initial inspection documentation. If the Engineer determines that an in-service orientation/training
    would be beneficial; the Engineer will make a recommendation to the Department Manager. Should a
    manufacturer in-service demonstration be required, the Engineer will assist in coordinating this effort
    with the Department Manager.

    B. Testing of devices brought in for demonstration or trial evaluation

    1. The hospital is responsible for the safety of all patients, staff, and visitors; equipment for loan,
    evaluation or demonstration is tested prior to its use in the hospital, unless an emergency dictates
    otherwise. In this instance, the user should ensure with reasonable Certainty that the equipment is in
    safe working condition before operating. If the Equipment is to remain in the hospital subsequent to its
    emergency use, it must be Safety tested by the Biomedical engineering department.

    2. All electrical equipment that passes the Biomedical engineering safety inspection will have a
    biomedical equipment maintenance sticker affixed in a visible location, or equivalent, indicating that it
    has been inspected, and is safe for use in the Hospital. (Certain battery-operated devices may be
    excluded from the preventive maintenance programme, and will not have a sticker affixed. Devices
    included in the programme, but that does not require regular preventive maintenance, will also receive
    a “PM Exempt” sticker).

    3. Any equipment that fails the Biomedical engineering safety inspection will be returned to its
    originating source with a description of the failure. Such equipment/device will be prohibited from being
    used in the facility until it has been repaired and satisfactorily passes the safety inspection.

    C. Equipment intended for use in a clinical laboratory application

    Vendor provided equipment in exchange for the purchase of reagents or consumables must be
    approved by hospital management, the clinical laboratory, or pathology department manager and safety
    tested prior to being placed into service. Hospital technical staff is not responsible for the maintenance
    of this equipment.

    5.0 Annexure:
    New Equipment received form

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