1 Introduction

This manual should be read in conjunction with the NICE HealthTech programme manual. This sets out the process for developing interventional procedures guidance.

NICE assesses the efficacy and safety of interventional procedures used for treatment or diagnosis to determine whether they work well enough and are safe enough for use in the NHS. Procedures that involve incision, puncture and entry into a body cavity, or that use ionising, electromagnetic or acoustic energy can be assessed. Mostly new procedures are investigated but established procedures can also be investigated if there is uncertainty about their efficacy or safety. Interventional procedures guidance can be updated when there is a change in the evidence base to justify this. No interventional procedure is entirely risk free, but the extent of uncertainties are gauged and recommendations are made on their implications for patients, clinicians and healthcare organisations.

NICE issues guidance on interventional procedures to help ensure that:

  • patients and carers:

    • are reassured that new procedures are being monitored and assessed to protect patient safety

    • have access to information about new procedures (NICE produces information for the public for each procedure)

  • clinicians, healthcare organisations and the NHS as a whole are supported in the process of introducing new procedures.

NICE encourages the safe introduction of innovation by:

  • providing advice on the efficacy and safety of new procedures

  • recommending training and other conditions for use of procedures in the NHS

  • facilitating data collection and analysis.

NICE was established in legislation as an England‑only body. However, we have agreements with the devolved administrations so that interventional procedures guidance applies in Wales and Northern Ireland.

NHS clinicians are responsible for applying NICE guidance, in their local context, in light of their duties to avoid unlawful discrimination and to promote equality. Nothing in the guidance should be interpreted in a way that would be inconsistent with compliance with these duties.

See section 10 for a glossary of terms used in this document.