| Innovative | A new or modified procedure that differs from currently accepted local practice, the outcomes of which have not been fully systematically evaluated and reported in a standardised manner, and which may entail unknown risks to the patient.23 39 This can include the introduction of entirely new procedures as well as undertaking modifications to existing techniques.
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| And: |
| An invasive procedure or a device | An invasive procedure will be defined as one in which purposeful and deliberate access to the body is gained via an incision or percutaneous puncture, instrumentation is used in addition to a puncture needle or instrumentation occurs via a natural orifice. It begins when entry to the body is gained and ends when the instrument is removed and/or the skin is closed. It is performed by trained healthcare professionals using instruments, which include, but are not limited to, endoscopes, catheters, scalpels, scissors, devices and tubes.40 A device is defined as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, which is intended by the manufacturer to be used for human beings.41
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