NICE 2002/0019
Issued: 02 April 2002

Press release

On 1st April 2002 responsibility for producing guidance on the safety and efficacy of new interventional procedures - for example, new applications for key-hole surgery - transferred to the National Institute for Clinical Excellence (NICE or the Institute). The transfer to NICE is one of a number of recommendations made by the Kennedy Report (Bristol Royal Infirmary Inquiry). The recommendations aim to produce an NHS centred on patients' needs in which systems are in place to ensure safe care and to maintain and improve the quality of care.

NICE has issued a consultation paper inviting comments from organisations representing healthcare professionals, patients and carers, and other stakeholders on its proposals for the establishment of a new programme to assess the safety and efficacy of new interventional procedures. These proposals include:

The aims of the programme
The establishment of an advisory committee for assessing the safety and efficacy of new interventional procedures
The organisation that will be required to support the work of the committee
The methods of identifying new procedures
The processes for investigating new procedures
How conclusions from investigations will be made and disseminated
The key relationships that the Institute will form to help with its work.

The consultation document has been circulated to relevant stakeholders and was published on the Institute's website on 02 April 2002. Comments on the document should be submitted to NICE by 1st July 2002.

Professor Bruce Campbell, formerly a member of the NICE Appraisals Committee, has agreed to take on the role of Chairman of the advisory committee for assessing the safety and efficacy of new interventional procedures. Professor Campbell is a Consultant Vascular and General Surgeon at the Royal Devon and Exeter Healthcare Trust, Chairman of Clinical Audit Committee for Exeter, and Chairman of the Health Technology Assessment Therapeutics Procedures Panel.

Ends

For more information contact:
Phil Ranson or Louise Fish

Notes for editors:

1. The National Institute for Clinical Excellence (NICE or the Institute) is part of the NHS and its role is to support healthcare professionals and patients in making decisions about individual patient care. For more information visit the NICE website at www.nice.org.uk.

2. NICE uses teams of experts to produce guidance for the NHS on:

use of new and existing health technologies (technology appraisals)

management and care of specific conditions (clinical guidelines)

safe and effective use of new surgical procedures (guidance on new interventional procedures)

lessons learnt following investigations of deaths and serious incidents in specific clinical circumstances (confidential enquiries).

3. The NICE Board agreed, at its meeting in November 2001, that if responsibility for managing new interventional procedures was transferred to NICE it should be organised on the following basis:

An Institute Committee would be established to receive proposals, provide advice to the Institute on the categorisation of new interventional procedures, and review categorisation when required.

The Guidance Executive will receive and approve the guidance for dissemination.

A medically qualified Programme Director would be appointed to manage the new interventional procedures work programme on a similar basis to the programme directors who manage the existing Institute work programmes.

A project manager would support the Programme Director with a similar role to the project managers in the Institute's Appraisals Team. Administrative support will be provided as required.

Assessment reports would be commissioned from an appropriate body and provided to the Committee to assist in the decision making process.

NICE would consult with its stakeholders on the arrangements for managing the new interventional procedures work programme once responsibility has been formally referred to the Institute.

NICE issued a consultation document to seek the views of stakeholders on its proposals for managing new interventional procedures. The consultation period being 02 April 2002 to 01 July 2002.

4. During the period of the consultation, NICE would welcome information about new interventional procedures. Those wishing to inform NICE about a new interventional procedure in their area of work should supply the following information:

The name of the procedure

Whether it is similar to established procedures or a completely new type of procedure

Which existing procedure/s it might replace

The specialty/specialties likely to undertake the procedure

A brief description of what is involved in doing the procedure

The intended health gain of the procedure

The patients likely to benefit

Possible adverse effects

Contact NICE by either emailing: ip@nice.nhs.uk or writing to:

New Interventional Procedures
National Institute for Clinical Excellence
11 Strand London
WC2N 5HR

5. The Safety and Efficacy Register of New Interventional Procedures, or SERNIP as it was known before its transfer to NICE, was set up as a pilot project in May 1996 under the auspices of the Academy of Medical Royal Colleges. The pilot was funded by the Department of Health and was established following concerns raised by the rapid uptake of minimal access (key-hole) surgery across the NHS. Its remit was to proscribe unsafe procedures, limit dissemination of unproven techniques and promote primary research into safety and efficacy, with the overall aim of providing a level of protection and assurance to patients, without stifling innovation by clinicians. Its terms of reference of were:

To examine new interventional procedures and advise on their safety and efficacy based upon objective data presented to them

To maintain a register of classified new interventional procedures

To encourage voluntary reporting of novel interventional procedures.

The Academy of Medical Royal Colleges relinquished their responsibility for the project on 30th September 2001 and an interim function was managed by the Department of Health prior to the transfer of responsibility to NICE.

1.	The National Institute for Clinical Excellence (NICE or the Institute) is part of the NHS and its role is to support healthcare professionals and patients in making decisions about individual patient care. For more information visit the NICE website at www.nice.org.uk.

2.	NICE uses teams of experts to produce guidance for the NHS on:
	use of new and existing health technologies (technology appraisals) management and care of specific conditions (clinical guidelines) safe and effective use of new surgical procedures (guidance on new interventional procedures) lessons learnt following investigations of deaths and serious incidents in specific clinical circumstances (confidential enquiries).
3.	The NICE Board agreed, at its meeting in November 2001, that if responsibility for managing new interventional procedures was transferred to NICE it should be organised on the following basis:
	An Institute Committee would be established to receive proposals, provide advice to the Institute on the categorisation of new interventional procedures, and review categorisation when required. The Guidance Executive will receive and approve the guidance for dissemination. A medically qualified Programme Director would be appointed to manage the new interventional procedures work programme on a similar basis to the programme directors who manage the existing Institute work programmes. A project manager would support the Programme Director with a similar role to the project managers in the Institute's Appraisals Team. Administrative support will be provided as required. Assessment reports would be commissioned from an appropriate body and provided to the Committee to assist in the decision making process. NICE would consult with its stakeholders on the arrangements for managing the new interventional procedures work programme once responsibility has been formally referred to the Institute. NICE issued a consultation document to seek the views of stakeholders on its proposals for managing new interventional procedures. The consultation period being 02 April 2002 to 01 July 2002.
4.	During the period of the consultation, NICE would welcome information about new interventional procedures. Those wishing to inform NICE about a new interventional procedure in their area of work should supply the following information:
	The name of the procedure Whether it is similar to established procedures or a completely new type of procedure Which existing procedure/s it might replace The specialty/specialties likely to undertake the procedure A brief description of what is involved in doing the procedure The intended health gain of the procedure The patients likely to benefit Possible adverse effects
	Contact NICE by either emailing: ip@nice.nhs.uk or writing to: New Interventional Procedures National Institute for Clinical Excellence 11 Strand London WC2N 5HR

5.	The Safety and Efficacy Register of New Interventional Procedures, or SERNIP as it was known before its transfer to NICE, was set up as a pilot project in May 1996 under the auspices of the Academy of Medical Royal Colleges. The pilot was funded by the Department of Health and was established following concerns raised by the rapid uptake of minimal access (key-hole) surgery across the NHS. Its remit was to proscribe unsafe procedures, limit dissemination of unproven techniques and promote primary research into safety and efficacy, with the overall aim of providing a level of protection and assurance to patients, without stifling innovation by clinicians. Its terms of reference of were:
	To examine new interventional procedures and advise on their safety and efficacy based upon objective data presented to them To maintain a register of classified new interventional procedures To encourage voluntary reporting of novel interventional procedures. The Academy of Medical Royal Colleges relinquished their responsibility for the project on 30th September 2001 and an interim function was managed by the Department of Health prior to the transfer of responsibility to NICE.