Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices

1st Edition - October 26, 2012

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  • Editor: Jean-Pierre Boutrand
  • eBook ISBN: 9780857096456
  • Hardcover ISBN: 9780857090706

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Description

Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe and biocompatible, and that they will perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices.Part one introduces the key concepts and challenges faced in relation to biocompatibility in medical devices, with consideration of biological safety evaluation planning and biomechanical and biochemical compatibility in innovative biomaterials. Part two goes on to discuss the evaluation and characterisation of biocompatibility in medical devices. Topics covered include material and chemical characterisation, allowable limits for toxic leachables, in vivo and in vitro testing and blood compatibility assessment. Testing and interpreting medical device performance is the focus of part three, with chapters describing preclinical performance studies for bone, dental and soft tissue implants, and mechanical testing of soft and hard tissue implants. Part four provides information on the regulation of medical devices in the European Union, Japan and China, and the book concludes with part five, a review of histopathology principles for biocompatibility and performance studies.With its distinguished editor and international team of expert contributors, Biocompatibility and performance of medical devices is a vital tool for all those involved in the research, design, production and application of medical devices, including research directors, production companies and medical regulatory agencies, as well as industry professionals and academics.

Key Features

  • Examines the key concepts and challenges faced in relation to biocompatibility in medical devices
  • Discusses evaluation and characterisation issues, including material and chemical characterization, allowable limits for toxic leachables, in vivo and in vitro testing, and blood compatibility assessment
  • Delivers a comprehensive overview of testing and interpreting medical device performance

Readership

Quality and Research directors/managers; Regulatory Affairs staff at companies which produce medical devices and related biotechnologies

Table of Contents

  • Contributor contact details

    Woodhead Publishing Series in Biomaterials

    Foreword

    Introduction

    Dedication

    Part I: Introduction to biocompatibility in medical devices

    Chapter 1: Concepts in biocompatibility: new biomaterials, new paradigms and new testing regimes

    Abstract:

    1.1 Introduction: traditional biomaterials and biocompatibility test procedures

    1.2 The evolution from implantable medical devices to regenerative medicine and bionanotechnology

    1.3 New concepts and definitions for biocompatibility

    1.4 A proposed conceptual framework for new biocompatibility concepts and testing regimes

    1.5 Conclusions and future trends

    Chapter 2: Challenges in biocompatibility and failure of biomaterials

    Abstract:

    2.1 Introduction

    2.2 Concept of biocompatibility

    2.3 Examples of device recalls or alerts during the last decade in which biocompatibility issues were considered

    2.4 Challenges in biocompatibility evaluation

    2.5 Conclusion

    Chapter 3: Biological safety evaluation planning of biomaterials

    Abstract:

    3.1 Introduction

    3.2 The fundamentals of safety evaluation planning

    3.3 Safety evaluation planning for biomaterials

    3.4 Developing and documenting plans

    3.5 Using safety evaluations

    3.6 Conclusion

    Chapter 4: Biomechanical and biochemical compatibility in innovative biomaterials

    Abstract:

    4.1 Introduction

    4.2 Selection of biomaterials

    4.3 Three generations of biomedical materials

    4.4 State-of-the-art development

    4.5 Future trends

    4.6 Conclusion

    Part II: Evaluation and characterisation of biocompatibility in medical devices

    Chapter 5: Material and chemical characterization for the biological evaluation of medical device biocompatibility

    Abstract:

    5.1 Introduction

    5.2 Background

    5.3 Requirements of ISO 10993

    5.4 Characterization of materials

    5.5 Chemical characterization of extracts

    5.6 Using chemical and material characterization to demonstrate equivalency

    5.7 Acceptance criteria for equivalency

    5.8 Risk assessment of extracts

    5.9 Conclusion and future trends

    Chapter 6: Allowable limits for toxic leachables: practical use of ISO 10993-17 standard

    Abstract:

    6.1 Introduction

    6.2 Process for setting tolerable intake (TI) values for compounds released from medical device materials

    6.3 Derivation of non-cancer TI values

    6.4 Derivation of cancer-based TI values

    6.5 Derivation of TI values for local effects

    6.6 Other issues to consider

    6.7 Conclusion

    Chapter 7: In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices

    Abstract:

    7.1 Introduction

    7.2 Pre-testing considerations

    7.3 Sample preparation

    7.4 In vitro testing

    7.5 In vivo testing

    7.6 Conclusion

    Chapter 8: Practical approach to blood compatibility assessments: general considerations and standards

    Abstract:

    8.1 Introduction

    8.2 Background: blood composition

    8.3 Critical distinguishing factors presented by blood-contacting medical devices

    8.4 Responses in fluid blood in contact with medical devices

    8.5 Responses by materials, or upon their surfaces, in contact with blood

    8.6 Assessing hemocompatibility according to international standards

    8.8 Sources of further information and advice

    Chapter 9: Medical device biocompatibility evaluation: an industry perspective

    Abstract:

    9.1 Introduction

    9.2 Developing a biological evaluation plan

    9.3 Implementing a biological evaluation plan

    9.4 Biological safety testing

    9.5 Creating a biological evaluation report

    9.6 Conclusion and future trends

    9.7 Sources of further information and advice

    9.9 Appendix: example of a material component biological evaluation report template

    1.0 Introduction

    2.0 Chemical characterization

    3.0 Manufacturing processing

    4.0 Tissue contact

    5.0 Evaluation of ISO 10993-1 compliance

    6.0 Discussion

    7.0 Conclusions

    Chapter 10: Case study: overcoming negative test results during manufacture

    Abstract:

    10.1 Introduction

    10.2 Cardio Medical: a fictitious case study

    10.3.The biological safety program

    10.4.Extractables and leachables

    10.5 Controlling risk at the manufacturing level

    10.6 Sterilization residuals

    10.7 Conclusion

    Chapter 11: Methods for the characterisation and evaluation of drug-device combination products

    Abstract:

    11.1 Introduction to combination products

    11.2 Combination product regulation

    11.3 Demonstrating safety and efficacy of combination products

    11.4 Pre-clinical testing of combination products

    11.5 Aspects to consider in the manufacture of combination products

    11.6 Clinical studies for combination products

    11.7 Conclusion and future trends

    Part III: Testing and interpreting the performance of medical devices

    Chapter 12: Methods and interpretation of performance studies for bone implants

    Abstract:

    12.1 Introduction

    12.2 Definitions

    12.3 Scope

    12.4 Principles for the selection of an in vivo model to evaluate performance of bone implants

    12.5 Designing a study to evaluate performance of bone implants

    12.6 Selection of reference products and controls

    12.7 Osteoinductive and osteogenic performances

    12.8 In vitro limitations

    12.9 Fracture repair models

    12.10 Spinal fusion models

    12.11 Cylindrical defect models

    12.12 Segmental defect models

    12.13 Antimicrobial performances of implants

    12.14 Bioabsorbable and biodegradable materials

    12.15 Bone debris interaction with implant performance

    12.16 Conclusion

    Chapter 13: Methods and interpretation of performance studies for dental implants

    Abstract:

    13.1 Introduction and definitions

    13.2 Importance of performance evaluation studies for dental implants

    13.3 Experimental design of a performance trial for dental implants

    13.4 Choice of model

    13.5 Statistical power calculation and analysis

    13.6 Analysis

    13.7 Translation from animal studies to human clinical trials

    13.8 Acknowledgments

    Chapter 14: Non-clinical functional evaluation of medical devices: general recommendations and examples for soft tissue implants

    Abstract:

    14.1 Introduction and definitions

    14.2 The purpose of functional studies

    14.3 Standards and documentation

    14.4 How to design a functional study

    14.5 Combining non-clinical functional studies with requirements of safety standards

    14.6 Conclusion

    Chapter 15: Mechanical testing for soft and hard tissue implants

    Abstract:

    15.1 Introduction

    15.2 Principles of setting up a mechanical test

    15.3 Implant-specific mechanical performance testing

    15.4 Advanced therapy products (ATPs) – cartilage

    15.5 Conclusion and future trends

    15.6 Sources of further information and advice

    Part IV: International regulation of medical devices

    Chapter 16: Biological evaluation and regulation of medical devices in the European Union

    Abstract:

    16.1 Introduction

    16.2 The regulatory and legislative framework

    16.3 Essential requirements

    16.4 Presumption of conformity

    16.5 Using the EN ISO 10993 series of standards to meet the essential requirements

    16.6 The notified body

    16.7 Common pitfalls in biological evaluations

    16.8 Managing positive results in the biological safety assessment

    16.9 Presenting the biological evaluation within the technical file

    16.10 Conclusion

    16.11 Sources of further information and advice

    16.12 Appendix: model content of the biological evaluation submission

    Chapter 17: Biological evaluation and regulation of medical devices in Japan

    Abstract:

    17.1 Introduction

    17.2 Outline of biological safety testing in Japan

    17.3 Biological safety tests

    17.4 Relationship and comparison between the International Organization for Standardization (ISO) standard and American Society for Testing and Materials (ASTM) standard

    17.5 Relationship between classification, examination, and certification in Japan

    17.6 Outline of the medical device Good Laboratory Practice (GLP)

    17.7 Conclusion

    Chapter 18: Medical device regulations in China

    Abstract:

    18.1 Introduction

    18.2 Interpretation of ISO 10993 and additional State Food and Drug Administration (SFDA) requirements

    18.3 Major professional bodies

    Part V: Histopathology principles for biocompatibility and performance studies

    Chapter 19: Microscopic and ultrastructural pathology in medical devices

    Abstract:

    19.1 Introduction

    19.2 Morphologic assessment in the safety studies of biomaterials and medical devices

    19.3 Assessment of the performance of biomaterials and medical devices

    19.4 Processing and sectioning of specimens

    19.5 Staining recommendations

    19.6 Qualitative and quantitative pathology used in the evaluation of biomaterials and medical devices

    19.7 Ultrastructural pathology

    19.8 Morphologic assessment of ocular medical devices

    19.9 Conclusion

    19.10 Acknowledgments

    Index

Product details

  • No. of pages: 544
  • Language: English
  • Copyright: © Woodhead Publishing 2012
  • Published: October 26, 2012
  • Imprint: Woodhead Publishing
  • eBook ISBN: 9780857096456
  • Hardcover ISBN: 9780857090706

About the Editor

Jean-Pierre Boutrand

Jean-Pierre Boutrand is General Manager and Scientific Director for the European division of NAMSA (the world leading medical device evaluation company). Dr Boutrand has been involved in more than 100 public presentations and publications on topics related to medical device evaluation and is registered as an expert on the biological safety of medical devices for ANSM (the French agency for the safety of health products).

Affiliations and Expertise

Biomatech, France

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