Device development procedures highlighted

This was the subject under discussion at a recent seminar, hosted by the Royal College of Surgeons. SUZANNE CALLANDER reports.

The aim of the seminar was to explore the introduction of new medical innovation and technologies, focusing on the regulation of new devices and the effects they have, from the patient perspective. The Royal College of Surgeons (RCS) is keen to establish itself at the forefront of the agenda on these issues. Professor Norman Williams, president of the RCS welcomed the audience, which comprised representatives from patient liaison groups, industry and clinicians. The seminar explored four key areas – the promotion of innovation while protecting the patient; concentrating research using networks to deliver training for new innovations and spreading best practice; developing codes of practice and ethical standards looking at the boundaries of health professionals and those involved in commercialising new techniques and the need for openness about potential conflicts of interest; and the need for greater clarity on the role of regulators. The first speaker was Professor Bruce Campbell, chair of the National Institute for Health and Clinical Excellence (NICE) Interventional Procedure (IP) and Medical Technologies Advisory Committees (MTAC). Prof. Campbell was instrumental in setting up the IP programme at the end of 2001, with the aim of producing guidance on new procedures to protect patients from harm, while still allowing them early access to potentially beneficial treatments, and to provide recommendations about the training, expertise and facilities required by clinicians when using new procedures. The remit and scope of the IP programme involves all techniques that include incision, puncture, entry into body cavities, ionisation radiation, electromagnetic and acoustic energy. “The programme is about procedures, not specific devices,” said Prof. Campbell. “So, when we are notified about a device which is the only way of undertaking a procedure, we will still insist that we need the name of a procedure. We advise that any clinician who intends to use a procedure for the first time in the NHS should look at the NICE website. If it is genuinely a new procedure, they should notify it.” To date, IPAC has published over 400 guidances. “When deciding whether to produce guidance on a new technique, the main questions revolve around whether safety and efficacy are likely to differ enough from existing techniques,” said Prof. Campbell. He went on to explain more about the evidence that is used to evaluate a procedure under review. “We collect information from published studies. We seek advice from specialist medical advisers to get the context for the procedure and also speak to patient commentators as well as using the extensive knowledge of the committee members. All of this information is subject to regular public consultation and this is a very important part of the evaluation.” Referring to the evidence required for future review guidance, Prof. Campbell said: “I press the committee to specify details of research outcomes required to review and update existing guidance. We now specify what we need to know when we review the guidance. We also now make recommendations for data collection, which is an adjunct to published scientific research. Why do we need data? In part because the coding system is not adequate to track many of the procedures. Indeed, many new procedures do not have a Hospital Episodes Statistics (HES) code. We are working hard with the coding centre to try and agree the introduction of early, sensible and single codes for new procedures, which would allow us to flag-up procedures which are currently under special arrangements guidance.” Prof. Campbell believes that registers are an important tool to provide further evidence for NICE IP guidance. “Registers produce large patient numbers which can be added to the published evidence when we produce guidance. Our aspiration would be for data collection on a national basis on all procedures for which the evidence is uncertain. Ideally, this would employ some kind of adaptable template system which could be used a different procedures. We are currently liaising with existing registers, in some cases setting up new parts of them dedicated to selected new procedures. NICE is also in discussion with the Association of British Healthcare Industry (ABHI) regarding post-marketing surveillance data. NICE believes that, if used and set up in the right way, these data could be used like a register, provided it has independent oversight and providing it is transparent. We are keen to develop this in association with manufacturers on an international scale.” Prof. Campbell also chairs the Medical Technologies Evaluation Programme (MTEP), which was set up following Lord Darzi’s 2008 NHS review which suggested that NICE should set up a programme to identify and evaluate innovative technologies that could be beneficial to the NHS and to produce guidance to speed up adoption. Devices are notified to MTEP by the manufacturer. The Medical Technologies Advisory Committee (MTAC) then examines the evidence to see if the technology offers advantages over current clinical management, in terms of patient outcome, patient experience, better use of resources, costs and sustainability. It looks at whether there are measurable advantages compared with current practice. Ideally, new technologies should offer a ‘step change’. NICE is also providing funding for fostering research, to see whether the benefits of a procedure can be achieved in practice. The aim is to boost the adoption of novel and useful technologies, to improve research into devices and diagnostics by advising companies and to foster research on promising products.

The role of the regulator