Read the latest HealthWatch newsletter:  Issue 109, Summer 2019

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Evidence, Healthcare and Medical Devices & Implants

Note: correct at 29 May 2019, but subject to further development — check this page for updates.

Date

Monday 17 June 2019

Location

The Garden Room, St Luke’s Community Centre, 90 Central Street, London EC1V 8AJ.

Accessibility

The building and room are fully wheelchair accessible and fitted with a hearing induction loop, but please let us know if you require the hearing loop.

Book your free place now

Aim

To clarify the current issues facing evidence based healthcare in the field of implants and medical devices and to identify areas where organisations (including HealthWatch) might most productively concentrate their efforts.

Objectives

By the end of the symposium participants will:

  • Have a clearer picture of the rules and regulations relating to medical devices
  • Be able to identify areas where evidence requirements coincide with the interests of healthcare organisations
  • Have developed a priority list of potential actions and activities

Structure

Briefing paper on current and proposed approval and regulatory processes in advance, coffee on arrival, brief plenary presentations, working groups with invited introductory presentations and discussants, coffee, report back, summing up.

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Programme

13:00 Introduction and presentation of briefing paper
13:10 Plenary presentations
14:00 Breakout workshops / discussion groups: Part 1: four groups charged with dealing first with one of four major topics. Invited presenter: very brief information handout plus 10 min introduction Structured discussion with conclusions to feedback including proposed actions
14.45 Coffee and return to groups for Part 2: General discussion of the other three topics prior to plenary session
15:30 General session: Five-minute feedback from each group in turn plus five-minute comments from the floor (which will have been enabled by the part 2 workshop discussions) plus final five minutes to gain some sense of collective opinion of main points
16:15 Round up session: Presenters and discussants to give two minutes on their thoughts from the meeting
16:25 Closing comments
16:30 Close
16:30 – 17:00 Optional networking session with tea

Post meeting

Meeting report collated and developed from:

  • Main briefing paper
  • Slides from plenary presenters
  • Brief papers from group presenters
  • Reporters from discussion groups / workshops
  • Report of final plenary session

Introductions

Introduction and Symposium Chair John Kirwan, Emeritus Professor of Rheumatic Diseases, University of Bristol; HealthWatch Trustee
Regulatory Frameworks background paper

Till Bruckner, TranspariMED & Transparify, Bristol and London

Plenary presentations

Lessons from surgical mesh Carl Heneghan Professor of Evidence-Based Medicine and Director of the Centre for Evidence-Based Medicine, Oxford University, Oxford
Current regulations fail to protect Deborah Cohen Investigative Journalist, British Medical Journal and BBC, London
The IDEAL Collaboration and necessary evidence Peter McCulloch Professor of Surgical Science and Practice and Chair of the IDEAL Collaboration, Oxford University, Oxford

Discussion Groups

Topic Presenter Moderator Reporter
A: Using a registry: How long term follow-up provides relevant evidence. Andy Judge, Professor of Translational Statistics, University of Bristol Leeza Osipenko, Senior Lecturer in Practice, Department of Health Policy, London School of Economics and Political Science, London Mandy Payne, Freelance medical journalist; HealthWatch Newsletter Editor
B: Evidence and evidence synthesis for non-randomised studies of medical devices and implants. Barnaby Reeves, Professorial Research Fellow in Health Services Research, University of Bristol; Co-Chair, Cochrane Non-Randomised Studies Methods Group Peter Wilmshurst, Consultant Cardiologist, Royal Stoke University Hospital, Stoke on Trent Alan Henness, Director of the Nightingale Collaboration; HealthWatch Trustee
C: Risk vs numbers – where do we concentrate? Andrew Cook, Consultant in Public Health Medicine and Fellow in Health Technology Assessment at the University of Southampton Roger Fisken, Consultant Physician; HealthWatch Trustee Jolene Galbreath, Royal United Hospitals Bath NHS Foundation Trust and HealthWatch Junior Doctor Representative
D: How can the healthcare community better support regulation for patient benefit? Neil McGuire, Senior Clinician Devices, Medicines & Healthcare products Regulatory Agency, London Anne Raikes, Chartered Accountant; HealthWatch Trustee Sofia Hart, HealthWatch Student Representative, London
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