NICE interventional procedures guidance

An interventional procedure is a procedure used for diagnosis or for treatment that involves:

  • making a cut or a hole to gain access to the inside of a patient's body - for example, when carrying out an operation or inserting a tube into a blood vessel, or
  • gaining access to a body cavity (such as the digestive system, lungs, womb or bladder) without cutting into the body - for example, examining or carrying out treatment on the inside of the stomach using an instrument inserted via the mouth, or
  • using electromagnetic radiation (which includes X-rays, lasers, gamma-rays and ultraviolet light) - for example, using a laser to treat eye problems.

NICE interventional procedures guidance covers:

  • the safety of the procedure
  • whether it works well enough for routine use
  • whether special arrangements are needed for patient consent

The guidance protects patients' safety and supports people in the NHS so that it is possible for new treatments and tests to be introduced into the NHS in a responsible way. Many of the procedures that NICE investigates are new, but we also look at more established procedures if there is uncertainty about their safety or how well they work.

Recommendations

There are four types of recommendations that NICE can make regarding whether the NHS should consider offering certain interventional procedures. These are:

  1. Use with standard arrangements for clinical governance, consent and audit

    This is the most positive recommendation that NICE can make for an interventional procedure. It means that there is enough evidence to show that the procedure works well enough and is safe enough for doctors to consider it as an option for their patients, providing that they follow their hospital's existing policies around getting permission to perform operations and monitoring the results afterwards.

    The recommendation does not mean that all patients who have the condition or symptom in question "should" or "must" be offered the procedure - this is decided at a local NHS level and usually on a case-by-case basis between the doctor and patient.

  2. Use with special arrangements for clinical governance, consent and audit

    NICE makes this recommendation if there are any uncertainties about the safety and/or efficacy of the procedure following the review of the published research; for example, if there is only evidence of a procedure's short term clinical benefits. NICE would also make this recommendation if there are known risks of serious harm which will need to be carefully explained to the patient beforehand.

    This recommendation puts a greater emphasis on the need for informed consent - both from the patient (and carer, if necessary) and from senior medics (usually the hospital's medical director) - and encourages healthcare professionals to closely monitor how their patients are doing afterwards and to facilitate further research (e.g. by submitting data to a national register).

  3. Use only in research

    This recommendation means that NICE believes that the procedure should be carried out only in the context of formal research studies, as approved by a research ethics committee.

    NICE would make this recommendation if the procedure is still considered to be experimental or because any uncertainties have to be resolved before more positive guidance regarding its use can be developed.

  4. Do not use

    NICE makes this recommendation if the evidence suggests that the procedure does not work very well, and/or if there are unacceptable safety risks.

 

View all our recommendations (Excel)

OPCS-4.6 codes

The NHS Classification service (NCS) is the authoritative source of clinical coding guidance. NCS has worked with NICE to assure accurate assignment of OPCS-4.6 codes for procedures covered by NICE guidance.

Developing interventional procedures guidance

An overview of the development process.

  1. Procedure notified to NICE

    Although clinicians most frequently notify procedures, anyone can make a notification. NICE assesses whether the notified procedure falls within the scope of the Interventional Procedures programme.

  2. Interest registered

    NICE lists all notified interventional procedures on the website. Individuals and organisations can register an interest in any interventional procedure. Consultees will be notified by email when consultation begins, and can submit comments.

  3. Overview prepared

    NICE consults at least three specialist advisors and prepares an overview of information about the procedure. An independent advisory committee considers the procedure. Read more about the Interventional Procedures Advisory Committee (IPAC).

  4. Consultation document produced

    If IPAC decides to produce guidance, NICE issues a consultation document on the safety and efficacy of the procedure. This is posted on the NICE website for a four-week consultation. See recent consultations.

  5. Final interventional procedures document produced

    IPAC considers the comments from the consultation, then produces final recommendations for the procedure. This is submitted to NICE for approval.

  6. Consultees notified

    Once NICE formally approves the final guideline, consultees are notified. They can request a resolution if they think the guidance is inaccurate or the guidance development process has not been followed.

  7. Guidance issued

    If there are no resolution requests, NICE issues its guidance to the NHS.

External Assessment Centres

After considering the brief and the available literature, the programme team may decide to refer a procedure to an External Assessment Centre for a systematic review. Criteria used to help identify procedures for which a systematic review might be appropriate include:

  • when the size of the evidence base is too large to prepare in the format of a standard overview
  • when the procedure has the potential to cause serious adverse events and the evidence, therefore, needs a complex statistical analysis to enable the Committee to make a decision
  • when the procedure has more than 1 indication or involves more than 1 technique.

Process and methods guide

The programme manual describes how NICE produces its guidance on interventional procedures. 

Using new interventional procedures

A summary of requirements for the NHS and clinicians.

View guidance

Notify a procedure to NICE

Interventional Procedures Advisory Committee

Find out more about the interventional procedures advisory committee, including how to attend a meeting.

'Being monitored' procedures

Some procedures fall within the remit of the Programme but their assessment is delayed. The reasons for this include:

  • the procedure is only being carried out in a research setting
  • the procedure does not have an evidence base
  • the procedure does not have appropriate CE marking

If a procedure notified to the Programme is not yet being used in the NHS or independent sector, or there is not an evidence base with which to assess it, the IP Programme monitors it and will assess it at a future date should the circumstances change.

View a list of procedures notified to NICE that are 'being monitored'

'Out of remit' procedures

Once a procedure has been notified, NICE determines whether it falls within the remit of the Programme. To fall within the Programme’s remit, a notified procedure must involve:

  • an incision or a puncture or entry into a body cavity, or the 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 standard clinical practice; or
  • be a standard clinical procedure, the efficacy or safety of which has been called into question by new information or advice.

Procedures do not fall within the Programme’s remit if they are considered standard clinical practice with an efficacy and safety profile that is sufficiently well known.

View a list of procedures notified to NICE that have been classed as 'out of remit'