12 May 2015

NICE Consults on Changes to Interventional Procedures Guidance Programme

Proposals now out for consultation seek to formalise the involvement of medical device manufacturers

NICE is updating the way it develops Interventional Procedures guidance to increase the speed and efficiency with which new surgical techniques and other technologies can be safely introduced into the NHS.

Amongst the changes, which are open for public consultation today, is a proposal to more formally recognise the role of device manufacturers in the development of guidance.

NICE’s Interventional Procedures guidance assesses the safety and efficacy of surgical procedures, and makes recommendations on whether special arrangements are needed for patient consent. Over the past 14 years, over 500 pieces of IP guidance have been published.

Under the proposals, medical device manufacturers will now be identified by NICE in the early stages of Interventional Procedure guidance development, if the procedure in question involves a device. Manufacturers will be asked to make a written submission of information about their product to NICE’s Interventional Procedures Advisory Committee, to aid the committee’s discussions. This brings the programme more into line with some of the Institute’s other guidance processes.  

The sort of information provided by the companies will include:

  • any internally-held data they have on the device’s safety and efficacy
  • details of any trials in progress or planned; and
  • any information they hold about where the device is currently being used in practice.

Companies identified will also be invited to attend relevant committee meetings, to answer questions about their product if the committee Chair deems it necessary.

Professor Bruce Campbell, Chair of NICE’s Interventional Procedures Advisory Committee, said: “Our Committee needs as much information as possible about a procedure in order to make a recommendation to the NHS about whether it is safe enough and works well enough to use routinely.

“As well as looking at the published evidence on procedures we already get the advice of doctors and of patients.  Many procedures involve using a new device and our proposals would mean that we could get additional information from manufacturers, to help our committee discussions and to make the most appropriate recommendations to the NHS.”

Other proposed changes to the Interventional Procedures programme at NICE include:

  • more pieces of guidance being reviewed for update every three years
  • changes to the wording used in guidance recommendations; and
  • changes to the guidance production timeline that could mean some Interventional Procedures guidance is published three to four weeks quicker than previously (guidance currently takes 37 weeks to develop).

Full details of all proposed changes are contained within the consultation document. NICE welcomes comments on the document from individuals and stakeholder organisations. The consultation period runs until 8th August 2015.   

Any questions about the changes or the consultation should be directed to sally.compton@nice.org.uk