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Sterilisation of biomaterials and medical devicesEdited by S Lerouge, Ecole de Technologie Supérieure, Canada and A Simmons, University of New South Wales, Australia
Woodhead Publishing Series in Biomaterials No. 46
- reviews established and commonly used technologies alongside new and emerging processes
- introduces and reviews the key concepts and challenges involved in sterilisation
- discusses future trends in the sterilisation of biomaterials and medical devices
- an essential reference for all materials scientists, engineers and researchers within the medical devices industry and provides a thorough overview for academics and clinicians working in this area
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.
ISBN 1 84569 932 7
ISBN-13: 978 1 84569 932 1
September 2012
352 pages 234 x 156mm hardback
£135.00 / US$230.00 / €160.00
Usually dispatched within 24 hours
About the editors
Sophie Lerouge is Professor of Mechanical Engineering at the École de technologie supérieure, Adjunct Professor in the Department of Radiology at the University of Montreal, and researcher at the University of Montreal Hospital Research Center (CRCHUM), Montreal, Canada.
Anne Simmons is Professor of Mechanical and Manufacturing Engineering at the University of New South Wales, Australia.
Titles which may also be of interest:
Sterilisation of tissues using ionising radiations
Joint replacement technology
Decontamination in hospitals and healthcare
Regulatory affairs for biomaterials and medical devices
Contents
Introduction to sterilisation: definitions and challenges
S Lerouge, Ecole de technologie supérieure, Canada
- Introduction
- Definitions of sterilisation in the context of biomaterials
- Validation, monitoring and safety of sterilisation methods
- Challenges and constraints of sterilisation methods
- Ideal versus real sterilisation methods
- Conclusions
- References
Introduction to sterilisation: definitions and challenges
S Lerouge, Ecole de technologie supérieure, Canada
- Introduction
- Definitions of sterilisation in the context of biomaterials
- Validation, monitoring and safety of sterilisation methods
- Challenges and constraints of sterilisation methods
- Ideal versus real sterilisation methods
- Conclusions
- References
Steam and dry heat sterilisation of biomaterials and medical devices
W J Rogers, Independent healthcare consultant, USA
- Introduction
- Steam sterilisation
- Different methods of steam sterilisation
- Test methods for the effectiveness of steam sterilisation
- Dry heat sterilisation
- Testing and validating dry heat sterilisation
- Conclusions
- Sources of further information
- References
Sterilisation of healthcare products by ionising radiation: principles and standards
B J Parsons, Leeds Metropolitan University, UK
- Introduction
- Interaction of ionising radiation with matter
- Sources of ionising radiation
- Validation and international standards of sterilisation by ionising radiation
- Conclusions and future trends
- Sources of further information and advice
- References
Ethylene Oxide (ETO) sterilisation of healthcare products
G C Mendes, T R S Brandao and C L M Silva, Universidade Católica Portuguesa, Portugal
- Introduction
- Parameters of ethylene oxide (ETO) sterilisation
- Use in the workplace and the environmental impact
- Sterilisation process characterization
- Process definition and qualification
- Process optimization and the process challenge device
- Qualification of ethylene oxide sterilisation
- Acknowledgements
- References
Non-traditional sterilisation techniques for biomaterials and medical devices
S Lerouge, Ecole de technologie supérieure, Canada
- Introduction
- Non-traditional sterilisation methods
- Novel non-traditional sterilisation methods
- Conclusions
- References
Sterilisation and decontamination of surfaces by plasma discharges
F Rossi, European Commission - Joint Research Centre, Italy and O Kylián Charles University, Czech Republic
- Introduction
- Overview of plasma generation
- Plasma generation at low and atmospheric pressures
- Interaction of plasma with biological pathogens: bacteria and bacterial spores
- Interaction of plasma with biological pathogens: pyrogens and proteins
- Further issues with the use of plasma for sterilisation purposes
- Conclusions and future trends
- References
Sterilisation techniques for polymers
W J Rogers, Independent healthcare consultant, USA
- Introduction
- Dry heat sterilisation
- Steam (moist heat) sterilisation
- Ethylene oxide (ETO) sterilisation
- Low temperature hydrogen peroxide with plasma
- Ozone sterilisation
- Radiation sterilisation
- Sterilisation and polymer efficiency
- Comparative efficiencies of sterilisation techniques for different polymers
- Post-implantation effects
- Dry heat sterilisation of silicones
- Ethylene oxide (ETO) sterilisation of polymers
- Sterilisation issues relating to biodegradable polymers and coatings
- Biocompatibility testing
- Conclusions
- Sources of further information
- References
Sterilisation of healthcare products by ionising radiation: sterilisation of drug-device products and tissue allografts
B J Parsons, Leeds Metropolitan University, UK
- Introduction
- The effect of radiation on aqueous systems
- Sterilisation of aqueous solutions of proteins and enzymes: reactions of free radicals with proteins
- The sterilisation of proteins in aqueous solution
- Sterilisation of drugs using radiation
- Sterilisation of drug delivery systems using radiation
- Sterilisation of tissue allografts using radiation
- Conclusions and future trends
- Sources of further information and advice
- References
Antimicrobial coatings for self-sterilisation
C W Dunnill and I P Parkin, University College London, UK
- Introduction
- Self-sterilising surfaces
- Antimicrobial metal surfaces
- Light activated antimicrobial surfaces
- Conclusions
- Future trends
- Sources of further information
- References
Prions and endotoxins: reprocessing strategies for reusable medical devices
L M Sehulster, Centers for Disease Control and Prevention, USA
- Introduction: prion disease epidemiology
- Prion resistance to inactivation: early research
- Current recommendations for instrument reprocessing
- Factors that impact the decision to use prion-inactivating methods
- Important issues associated with cleaning and decontamination
- Research developments towards a valid reprocessing strategy
- Bacterial endotoxins
- Device reprocessing strategies
- References
Future trends for the sterilisation of biomaterials and medical devices
A Simmons, University of New South Wales, Australia
- Introduction
- Common sterilisation techniques
- Future trends
- Conclusions
- References