The hospital has a formalised process to evaluate and select the
clinical products used across the hospital. Guidelines for the introduction of a new medical device
Approval for the introduction of all new medical devices or
consumables is required by the Clinical Products Evaluation
The introduction of new technology or clinical practice is
required from the New Technology or Clinical Practice
New Technology or Clinical Practice
Clinical Products Evaluation Committee
Clinicians seeking to introduce a new medical device are
required to complete a Request for New Medical Device Request Form (Word 65 KB).
All enquiries and applications to the Clinical
Products Evaluation Committee can be made via the following
email address: email@example.com
The specifications are used to describe the functional
characteristics of the device that are required to fulfil its
clinical purpose. The functional characteristics will include how
the device is used in the clinical setting, what it is used for and
what advantages it may afford the clinician or organisation as a
To specify a device the 'Request for a new medical device' form
should be completed by the clinician wanting to introduce the
device into the hospital. Technical specifications will be
completed in consultation with Biomedical engineering.
The initial assessment of the proposed new item is undertaken by
the Clinical Products Evaluation committee.
'Introduction of a new medical device flowchart' (PDF 41
By conducting a proper evaluation of a product, its suitability
for clinical use is determined. A person requesting a new
product will become the sponsor for that product.
Under the guidance of the Clinical Product Evaluation Committee,
sponsors will be responsible for:
- Preparing an evaluation
proposal (Word 51 KB) for the evaluation committee by following
proposal guidelines (PDF 67 KB).
- Establishing the key evaluation
criteria (Word 69 KB) for evaluating the particular
- Facilitating the product(s) evaluation. Product Evaluation Form (Word 89 KB)
- Completing an evaluation
report document (Word 105 KB)
Material resources will facilitate the eventual purchase of the
new medical device. The standard purchasing process applies and
an 'Evaluation and Purchasing
checklist' for all medical equipment new to RCH is
It is important to evaluate medical devices:
- To assess their suitability for a particular clinical environment
- To periodically test the market concerning the clinical devices we use
- Promotes research & development of medical devices in response to consumer feedback.
- Maintain best practice