Main description:

The effective sterilisation of any material or device to be implanted in or used in close contact with the human body is essential for the elimination of harmful agents such as bacteria. Sterilisation of biomaterials and medical devices reviews established and commonly used technologies alongside new and emerging processes.

Following an introduction to the key concepts and challenges involved in sterilisation, the sterilisation of biomaterials and medical devices using steam and dry heat, ionising radiation and ethylene oxide is reviewed. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for 'self-sterilisation' and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices. The book concludes with a discussion of future trends in the sterilisation of biomaterials and medical devices.

With its distinguished editors and expert team of international contributors, Sterilisation of biomaterials and medical devices is an essential reference for all materials scientists, engineers and researchers within the medical devices industry. It also provides a thorough overview for academics and clinicians working in this area.

Contents:

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Woodhead Publishing Series in Biomaterials

Chapter 1: Introduction to sterilization: definitions and challenges

Abstract:

1.1 Introduction

1.2 Definitions of sterilization in the context of biomaterials

1.3 Validation, monitoring and safety of sterilization methods

1.4 Challenges and constraints of sterilization methods

1.5 Ideal versus actual sterilization methods

1.6 Conclusions

Chapter 2: Steam and dry heat sterilization of biomaterials and medical devices

Abstract:

2.1 Introduction

2.2 Steam sterilization

2.3 Different methods of steam sterilization

2.4 Test methods for the effectiveness of steam sterilization

2.5 Dry heat sterilization

2.6 Testing and validating dry heat sterilization

2.7 Conclusions

Chapter 3: Sterilisation of healthcare products by ionising radiation: principles and standards

Abstract:

3.1 Introduction

3.2 Interaction of ionising radiation with matter

3.3 Sources of ionising radiation

3.4 Validation and international standards of sterilisation by ionising radiation

3.5 Conclusions and future trends

3.6 Sources of further information and advice

Chapter 4: Ethylene oxide (EO) sterilization of healthcare products

Abstract:

4.1 Introduction

4.2 Advantages of ethylene oxide (EO) sterilization

4.3 Disadvantages of ethylene oxide (EO) sterilization

4.4 Sterilization process characterization

4.5 Process definition

4.6 Process optimization and the process challenge device

4.7 Qualification of ethylene oxide (EO) sterilization

4.8 Contract sterilization

4.9 Acknowledgments

Chapter 5: Non-traditional sterilization techniques for biomaterials and medical devices

Abstract:

5.1 Introduction

5.2 Non-traditional sterilization methods

5.3 Novel non-traditional sterilization methods

5.4 Conclusions

Chapter 6: Sterilization and decontamination of surfaces by plasma discharges

Abstract:

6.1 Introduction

6.2 Overview of plasma generation

6.3 Plasma generation at low and atmospheric pressures

6.4 Interaction of plasma with biological pathogens: bacteria and bacterial spores

6.5 Interaction of plasma with biological pathogens: pyrogens and proteins

6.6 Further issues with the use of plasma for sterilization purposes

6.7 Conclusions and future trends

Chapter 7: Sterilisation techniques for polymers

Abstract:

7.1 Introduction

7.2 Dry-heat sterilisation

7.3 Steam (moist heat) sterilisation

7.4 Ethylene oxide (EO) sterilisation

7.5 Low-temperature hydrogen peroxide with plasma

7.6 Ozone sterilisation

7.7 Radiation sterilisation

7.8 Sterilisation and polymer efficiency

7.9 Comparative efficiencies of sterilisation techniques for different polymers

7.10 Post-implantation effects

7.11 Dry heat sterilisation of silicones

7.12 Ethylene oxide (EO) sterilisation of polymers

7.13 Sterilisation issues relating to biodegradable polymers and coatings

7.14 Biocompatibility testing5

7.15 Conclusions

Chapter 8: Sterilisation of healthcare products by ionising radiation: sterilisation of drug-device products and tissue allografts

Abstract:

8.1 Introduction

8.2 The effect of radiation on aqueous systems

8.3 Sterilisation of aqueous solutions of proteins and enzymes: reactions of free radicals with proteins

8.4 The sterilisation of proteins in aqueous solution

8.5 Sterilisation of drugs using radiation

8.6 Sterilisation of drug-delivery systems using radiation

8.7 Sterilisation of tissue allografts using radiation

8.8 Conclusions and future trends

8.9 Sources of further information and advice

Chapter 9: Antimicrobial coatings for aEURO~self-sterilisationaEURO (TM)

Abstract:

9.1 Introduction

9.2 Self-sterilising surfaces

9.3 Antimicrobial metal surfaces

9.4 Light-activated antimicrobial surfaces

9.5 Conclusions

Chapter 10: Prions and endotoxins: reprocessing strategies for reusable medical devices

Abstract:

10.1 Introduction: prion disease epidemiology

10.2 Prion resistance to inactivation: early research

10.3 Current recommendations for instrument reprocessing

10.4 Factors that impact the decision to use prion-inactivating methods

10.5 Important issues associated with cleaning/decontamination

10.6 Research developments towards a validated reprocessing strategy

10.7 Bacterial endotoxins

10.8 Device reprocessing strategies for endotoxin

Chapter 11: Future trends for the sterilisation of biomaterials and medical devices

Abstract:

11.1 Introduction

11.2 Common sterilisation techniques

11.3 Future trends

11.4 Conclusions

Index