Clinical Products Advisory

Guidelines for the introduction of a new medical device

  • Purpose

    Effective selection and procurement of medical devices is a necessary element of the hospital's clinical service delivery.  Providing the most appropriate equipment and consumable items for clinical use is dependent on a clear process that is understood across the hospital. 

    The purpose of the following guideline is to:

    • Ensure the most cost effective and clinically suitable products are selected for use at the RCH
    • Provide a consistent approach for the evaluation, selection and procurement of all medical devices for the RCH
    • Document the method and process used by RCH in the selection of clinical products and equipment
    • Ensure collaboration and active participation by hospital personnel in clinical evaluation and product selection
    • Identify the ongoing costs involved in the use, education and training for clinical products and equipment
    • Ensure all items purchased for clinical use comply with relevant standards
    • Provide the hospital with a document trail for the evaluation and selection of medical devices

    Approval for the introduction of all new medical devices is required by the Clinical Product Evaluation Committee.


    'Medical device' refers to any therapeutic goods, diagnostic equipment and consumables
    A 'new' medical device is any clinical equipment or consumable not currently used at the RCH or previously purchased by the RCH
    A 'major procurement' refers to any purchase that requires an open market procurement strategy including tender, expressions of interest or other formal procurement methods.
    'Minor procurement' includes purchases that only require in house evaluation and standard purchasing processes.

    Application Process

    Clinicians seeking to introduce a new medical device are required to complete a request form and submit to the Clinical Product Evaluation committee through one of the following.

    • Clinical Products Advisor - Briohny Lawrance (ext. 55498)
    • Chief Biomedical Engineer - Inna Velasquez (ext. 56193)
    • Material Resources Manager - Piotr Jakubicki (ext. 56498)

    The Clinical Product Evaluation committee will review all requests and determine whether it is a major or minor procurement.

    Major Procurements

    Where the procurement is of considerable value, formal procurement procedures should be undertaken. For example: Open tender, restricted tender, expressions of interest etc.  The Material Resources manager will decide on the most appropriate procurement method in accordance with hospital guidelines.

    Minor Procurements

    The Clinical Products Evaluation Committee will determine whether a product evaluation is necessary prior to the purchase of the medical device and ensure an appropriate evaluation committee is established for each product. These committees will be different for each item and will be established in conjunction with the person requesting the particular item.  The requestor for purchase of a particular medical device will become the "sponsor" for that item.

    Sponsor requirements

    Under the guidance of the Clinical Product Evaluation Committee, sponsors will be responsible for:
    1) Preparing an evaluation proposal for the evaluation committee by following the evaluation proposal guidelines
    2) Establishing the key evaluation criteria for evaluating the particular clinical item
    3) Facilitating the product(s) evaluation
    4) Completing an evaluation report document

    Reference Documents

    Procedure: 'Approval for the introduction of new medical technology, clinical practice, pharmaceutical agent or medical device.'