Process and methods
4 Remit of the programme
The interventional procedures programme's remit was set out by the Department of Health in 2003, in 'Health Services Circular 2003/11 – The interventional procedures programme: working with the National Institute for Clinical Excellence to promote safe clinical innovation'.
To fall within the programme's remit, a notified procedure must:
involve an incision, a puncture or entry into a body cavity, or use of ionising, electromagnetic or acoustic energy, and
be available within the NHS or independent sector, or be about to be used for the first time outside formal research, and
either not yet be generally considered established clinical practice, or
be an established clinical procedure, the efficacy or safety of which has been called into question by new information or advice and
have a CE mark specific for the notified indication if a device is involved.
Procedures do not fall within the programme's remit if they are considered standard clinical practice with a sufficiently well‑known efficacy and safety profile. All interventional procedures carry some risks. It is the extent of uncertainty surrounding the efficacy and safety of a procedure that the programme is concerned with. All decisions about whether procedures are in remit are recorded on NICE's website.
When NICE is notified of a procedure, it determines whether it falls within the remit of the programme. Notifications are regularly scrutinised by the interventional procedures technical team, the Chair and members of the Interventional Procedures Advisory Committee, and others as needed, to establish key facts about the procedure that were unclear in the notification. For each notified procedure, the programme team seeks advice from specialist advisers about the novelty of the procedure, its use in the UK and whether guidance from NICE would be helpful. If there are doubts about the suitability of a procedure for guidance, the final decision is made by the Centre Director in consultation with the Committee Chair. Once agreed, a brief is prepared and presented to the Committee, which considers whether the brief contains the necessary information to proceed to develop guidance.
NICE assesses procedures that involve a medical device if:
the procedure falls within the programme's remit, and
the device has at least 1 CE mark device allowing it to be used for the purpose and indication for which the procedure is intended.
If a procedure involving a specific device is notified, the programme team approaches the company or companies to ensure that at least 1 device has a CE mark that is current and relevant to the proposed indication. NICE interventional procedures guidance does not name, or relate to, specific devices.