Medical Devices: A Threat to European Patients

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Medical DevicesA Threat to European Patients?

• Do medical devices do more harm than good?
• If they do have the ability to cause harm, how
  can we balance innovation and risk better?

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Medical DevicesA Threat to European Patients?

• David Williams
•  
• Emeritus Professor, University of Liverpool, UK
• Professor, and Director of International
  Affairs, Wake Forest Institute of Regenerative
  Medicine, North Carolina, USA
• Visiting Professor, Christiaan Barnard Department
  of Cardiothoracic Surgery, Cape Town, South
  Africa,
• Visiting Professor, Graduate School of Biomedical
  Engineering, University of New South Wales,
  Australia
• Guest Professor, Tsinghua University, Beijing,
  China
•  Partner, Morgan Masterson Consulting, Brussels
• Editor-in-Chief, Biomaterials

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Medical DevicesA Threat to European Patients?

• David Williams
• Former member SCMPMD and SCENIHR, DG Sanco
• Former Director UK Centre for Tissue Engineering,
  University of Liverpool, UK
• Expert witness, medical device litigation in USA
• Over 40 years experience in biomaterials science
  and medical device technology

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The Laws of Biomaterials Selection

• Always remember with the biocompatibility of
  medical devices, the three most important
  mediators of clinical performance are, in this
  order
• The Quality of the Surgery
• The Characteristics of the Patient
• The Inherent Biocompatibility of the Material
• Williams D.F. On the mechanisms of
  biocompatibility, Biomaterials, 2008, 29(20),
  2941-53.

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The Laws of Biomaterials Selection

• When selecting materials for long term
  implantable devices, choose the material that
  optimises the functional properties of the
  device, consistent with maximum chemical and
  biological inertness
• The biocompatibility of a long term implantable
  medical device refers to the ability of the
  device to perform its intended function, with the
  desired degree of incorporation in the host,
  without eliciting any undesirable local or
  systemic effects in that host.

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Medical Device Failures That Harmed Patients

• More harm was inflicted on post-silicone breast
  implants than with the silicone gel filled
  implants themselves because of regulatory
  malfunction, allowing less safe materials onto
  the market triglycerides and Lipomatrix.
• Bjork Shiley heart valves, a very good
  haemodynamic valve but one mistake during design
  / manufacturing caused many deaths.
• Proplast and Vitek TMJ, very poor judgement about
  materials selection, happened prior to 1976
  Medical Device Amendment in USA. Could it happen
  today?
• Zirconia in joint replacement, lack of
  understanding about critical materials science
  issues.
• Polyimine in ICDs, a minor materials /
  manufacturing issue that received far too much
  attention because of media pressure that was
  undeserved on the basis of patient harm.
• No systematic failure modes, difficult to predict
  and avoid.

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The Future

• Need better post-market surveillance and the use
  of patient / device registries. This will become
  even more important with the advanced therapy
  products.
• It is necessary to better integrate diagnostic /
  imaging techniques with reconstructive procedures
  and patient monitoring.
• Need more predictive pre-clinical testing and
  modelling of performance.
• Need to be cognisant of surgical and patient
  variability in determining and monitoring
  performance.
• Need better independent scientific advice to
  underpin regulations, and better recognition of
  that scientific advice by the regulators.