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Read the latest HealthWatch newsletter:  Issue 108, Autumn 2018

Evidence, Healthcare and Medical Devices & Implants

Note: correct at 15 April 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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Agenda

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

Plenary presentations

Provisional title

Presenter

Role

Lessons from surgical mesh

Prof 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

Prof Peter McCulloch

Professor of Surgical Science and Practice and Chair of the IDEAL Collaboration, Oxford University, Oxford

Discussion Groups

Provisional topic title

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

Peter Wilmshurst, Consultant Cardiologist, Royal Stoke University Hospital, Stoke on Trent

Jolene Galbreath, Royal United Hospitals Bath NHS Foundation Trust and HealthWatch Junior Doctor Representative

B: Evidence synthesis: Only randomised controlled trials?

 

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

D: What rules and regulations do we want and how do we get them?

Neil McGuire, Clinical Director of Medical Devices, Medicines & Healthcare products Regulatory Agency, London
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