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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.
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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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