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Trends In Development Of Medical Devices

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Trends in Development of Medical Devices

Trends in Development of Medical Devices Book
Author : Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Publisher : Academic Press
Release : 2020-01-25
ISBN : 0128209615
Language : En, Es, Fr & De

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Book Description :

Trends in Development of Medical Devices covers the basics of medical devices and their development, regulations and toxicological effects, risk assessment and mitigation. It also discusses the maintenance of a medical device portfolio during product lifecycle. This book provides up-to-date information and knowledge on how to understand the position and benefits of new introduced medical devices for improving healthcare. Researchers and industry professionals from the fields of medical devices, surgery, medical toxicology, pharmacy and medical devices manufacture will find this book useful. The book's editors and contributors form a global, interdisciplinary base of knowledge which they bring to this book. Provides a roadmap to medical devices development and the integration of manufacturing steps to improve workflows Helps engineers in medical devices industries to anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, government regulations Presents new strategies that readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce imperfections in production and develop products that enable completely new treatment possibilities

Emerging Trends in Medical Plastic Engineering and Manufacturing

Emerging Trends in Medical Plastic Engineering and Manufacturing Book
Author : Markus Schönberger,Marc Hoffstetter
Publisher : William Andrew
Release : 2016-01-06
ISBN : 0323374654
Language : En, Es, Fr & De

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Book Description :

Emerging Trends in Medical Plastic Engineering and Manufacturing gives engineers and materials scientists working in the field detailed insights into upcoming technologies in medical polymers. While plastic manufacturing combines the possibility of mass production and wide design variability, there are still opportunities within the plastic engineering field which have not been fully adopted in the medical industry. In addition, there are numerous additional challenges related to the development of products for this industry, such as ensuring tolerance to disinfection, biocompatibility, selecting compliant additives for processing, and more. This book enables product designers, polymer processing engineers, and manufacturing engineers to take advantage of the numerous upcoming developments in medical plastics, such as autoregulated volume-correction to achieve zero defect production or the development of ‘intelligent’ single use plastic products, and methods for sterile manufacturing which reduce the need for subsequent sterilization processes. Finally, as medical devices get smaller, the book discusses the challenges posed by miniaturization for injection molders, how to respond to these challenges, and the rapidly advancing prototyping technologies. Provides a roadmap to the emerging technologies for polymers in the medical device industry, including coverage of ‘intelligent’ single use products, personalized medical devices, and the integration of manufacturing steps to improve workflows Helps engineers in the biomedical and medical devices industries to navigate and anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, and government regulations Presents tactics readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce defects in production and develop products that enable entirely new treatment possibilities

Innovation and Invention in Medical Devices

Innovation and Invention in Medical Devices Book
Author : Institute of Medicine,Board on Health Sciences Policy,Based on a Workshop of the Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
Publisher : National Academies Press
Release : 2001-10-31
ISBN : 9780309183208
Language : En, Es, Fr & De

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Book Description :

The objective of the workshop that is the subject of this summary report was to present the challenges and opportunities for medical devices as perceived by the key stakeholders in the field. The agenda, and hence the summaries of the presentations that were made in the workshop and which are presented in this summary report, was organized to first examine the nature of innovation in the field and the social and economic infrastructure that supports such innovation. The next objective was to identify and discuss the greatest unmet clinical needs, with a futuristic view of technologies that might meet those needs. And finally, consideration was given to the barriers to the application of new technologies to meet clinical needs.

Development of Medical Device Policies

Development of Medical Device Policies Book
Author : World Health Organization
Publisher : Unknown
Release : 2012-10-25
ISBN : 9789241501637
Language : En, Es, Fr & De

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Book Description :

WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: * policy framework for health technology * medical device regulations * health technology assessment * health technology management * needs assessment of medical devices * medical device procurement * medical equipment donations * medical equipment inventory management * medical equipment maintenance * computerized maintenance management systems * medical device data * medical device nomenclature * medical devices by health-care setting * medical devices by clinical procedures * medical device innovation, research and development. These documents are intended for use by biomedical engineers, health managers, donors, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional or global levels. The number of countries with existing health technology policies and with units to implement those policies shows that there is forward movement in the development and implementation of health technology policies. However, because medical devices are complex to select, manage and use, it is important to ensure that new policies are developed appropriately and existing ones are modified as necessary to make them as effective as possible. Proper integration of health technology policies and strategies within the framework of a national health plan has the potential to harness the political support to ensure improved access, quality and use of medical devices, enhance the best use of the resources in a framework of universal coverage, respond to the needs of the population, and ultimately achieve better health outcomes.

The Role of Human Factors in Home Health Care

The Role of Human Factors in Home Health Care Book
Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Human-Systems Integration,Committee on the Role of Human Factors in Home Health Care
Publisher : National Academies Press
Release : 2010-11-14
ISBN : 0309156297
Language : En, Es, Fr & De

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Book Description :

The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research-the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.

The Changing Economics of Medical Technology

The Changing Economics of Medical Technology Book
Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Release : 1991-02-01
ISBN : 030904491X
Language : En, Es, Fr & De

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Book Description :

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

The Business of Healthcare Innovation

The Business of Healthcare Innovation Book
Author : Lawton Robert Burns
Publisher : Cambridge University Press
Release : 2005-08-25
ISBN : 9781139445887
Language : En, Es, Fr & De

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Book Description :

The Business of Healthcare Innovation is the first wide-ranging analysis of business trends in the manufacturing segment of the health care industry. In this leading edge volume, Professor Burns focuses on the key role of the 'producers' as the main source of innovation in health systems. Written by professors of the Wharton School and industry executives, this book provides a detailed overview of the pharmaceutical, biotechnology, genomics/proteomics, medical device and information technology sectors. It analyses the market structures of these sectors as well as the business models and corporate strategies of firms operating within them. Most importantly, the book describes the growing convergence between these sectors and the need for executives in one sector to increasingly draw upon trends in the others. It will be essential reading for students and researchers in the field of health management, and of great interest to strategy scholars, industry practitioners and management consultants.

The Role of Telehealth in an Evolving Health Care Environment

The Role of Telehealth in an Evolving Health Care Environment Book
Author : Institute of Medicine,Board on Health Care Services
Publisher : National Academies Press
Release : 2012-12-20
ISBN : 0309262011
Language : En, Es, Fr & De

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Book Description :

In 1996, the Institute of Medicine (IOM) released its report Telemedicine: A Guide to Assessing Telecommunications for Health Care. In that report, the IOM Committee on Evaluating Clinical Applications of Telemedicine found telemedicine is similar in most respects to other technologies for which better evidence of effectiveness is also being demanded. Telemedicine, however, has some special characteristics-shared with information technologies generally-that warrant particular notice from evaluators and decision makers. Since that time, attention to telehealth has continued to grow in both the public and private sectors. Peer-reviewed journals and professional societies are devoted to telehealth, the federal government provides grant funding to promote the use of telehealth, and the private technology industry continues to develop new applications for telehealth. However, barriers remain to the use of telehealth modalities, including issues related to reimbursement, licensure, workforce, and costs. Also, some areas of telehealth have developed a stronger evidence base than others. The Health Resources and Service Administration (HRSA) sponsored the IOM in holding a workshop in Washington, DC, on August 8-9 2012, to examine how the use of telehealth technology can fit into the U.S. health care system. HRSA asked the IOM to focus on the potential for telehealth to serve geographically isolated individuals and extend the reach of scarce resources while also emphasizing the quality and value in the delivery of health care services. This workshop summary discusses the evolution of telehealth since 1996, including the increasing role of the private sector, policies that have promoted or delayed the use of telehealth, and consumer acceptance of telehealth. The Role of Telehealth in an Evolving Health Care Environment: Workshop Summary discusses the current evidence base for telehealth, including available data and gaps in data; discuss how technological developments, including mobile telehealth, electronic intensive care units, remote monitoring, social networking, and wearable devices, in conjunction with the push for electronic health records, is changing the delivery of health care in rural and urban environments. This report also summarizes actions that the U.S. Department of Health and Human Services (HHS) can undertake to further the use of telehealth to improve health care outcomes while controlling costs in the current health care environment.

New Medical Devices

New Medical Devices Book
Author : Institute of Medicine,National Academy of Engineering
Publisher : National Academies Press
Release : 1988-01-01
ISBN : 0309038472
Language : En, Es, Fr & De

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Book Description :

In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.

Sources of Medical Technology

Sources of Medical Technology Book
Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Release : 1995-01-01
ISBN : 9780309176682
Language : En, Es, Fr & De

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Book Description :

Evidence suggests that medical innovation is becoming increasingly dependent on interdisciplinary research and on the crossing of institutional boundaries. This volume focuses on the conditions governing the supply of new medical technologies and suggest that the boundaries between disciplines, institutions, and the private and public sectors have been redrawn and reshaped. Individual essays explore the nature, organization, and management of interdisciplinary R&D in medicine; the introduction into clinical practice of the laser, endoscopic innovations, cochlear implantation, cardiovascular imaging technologies, and synthetic insulin; the division of innovating labor in biotechnology; the government- industry-university interface; perspectives on industrial R&D management; and the growing intertwining of the public and proprietary in medical technology.

New Health Technologies

New Health Technologies Book
Author : Collectif
Publisher : OECD
Release : 2017-02-03
ISBN : 9264266445
Language : En, Es, Fr & De

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Book Description :

This report discusses the need for an integrated and cyclical approach to managing health technology in order to mitigate clinical and financial risks, and ensure acceptable value for money. The analysis considers how health systems and policy makers should adapt in terms of development, assessment and uptake of health technologies. The first chapter provides an examination of adoption and impact of medical technology in the past and how health systems are preparing for continuation of such trends in the future. Subsequent chapters examine the need to balance innovation, value, and access for pharmaceuticals and medical devices, respectively, followed by a consideration of their combined promise in the area of precision medicine. The final chapter examines how health systems can make better use of health data and digital technologies. The report focuses on opportunities linked to new and emerging technologies as well as current challenges faced by policy makers, and suggests a new governance framework to address these challenges.

Medical Devices

Medical Devices Book
Author : World Health Organization
Publisher : World Health Organization
Release : 2010
ISBN : 9241564040
Language : En, Es, Fr & De

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Book Description :

Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9

Medical Devices and the Public s Health

Medical Devices and the Public s Health Book
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Release : 2011-10-25
ISBN : 0309212456
Language : En, Es, Fr & De

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Book Description :

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

Hearing Health Care for Adults

Hearing Health Care for Adults Book
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Accessible and Affordable Hearing Health Care for Adults
Publisher : National Academies Press
Release : 2016-09-06
ISBN : 0309439299
Language : En, Es, Fr & De

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Book Description :

The loss of hearing - be it gradual or acute, mild or severe, present since birth or acquired in older age - can have significant effects on one's communication abilities, quality of life, social participation, and health. Despite this, many people with hearing loss do not seek or receive hearing health care. The reasons are numerous, complex, and often interconnected. For some, hearing health care is not affordable. For others, the appropriate services are difficult to access, or individuals do not know how or where to access them. Others may not want to deal with the stigma that they and society may associate with needing hearing health care and obtaining that care. Still others do not recognize they need hearing health care, as hearing loss is an invisible health condition that often worsens gradually over time. In the United States, an estimated 30 million individuals (12.7 percent of Americans ages 12 years or older) have hearing loss. Globally, hearing loss has been identified as the fifth leading cause of years lived with disability. Successful hearing health care enables individuals with hearing loss to have the freedom to communicate in their environments in ways that are culturally appropriate and that preserve their dignity and function. Hearing Health Care for Adults focuses on improving the accessibility and affordability of hearing health care for adults of all ages. This study examines the hearing health care system, with a focus on non-surgical technologies and services, and offers recommendations for improving access to, the affordability of, and the quality of hearing health care for adults of all ages.

Health Technology Assessment of Medical Devices

Health Technology Assessment of Medical Devices Book
Author : World Health Organization
Publisher : Who Medical Device Technical
Release : 2012-10-25
ISBN : 9789241501361
Language : En, Es, Fr & De

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Book Description :

WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: * policy framework for health technology * medical device regulations * health technology assessment * health technology management * needs assessment of medical devices * medical device procurement * medical equipment donations * medical equipment inventory management * medical equipment maintenance * computerized maintenance management systems * medical device data * medical device nomenclature * medical devices by health-care setting * medical devices by clinical procedures * medical device innovation, research and development. These documents are intended for use by biomedical engineers, health managers, donors, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional or global levels. HTA is the systematic evaluation of properties, effects, and/or impacts of health technology. Its main purpose is to inform technology-related policy-making in health care, and thus improve the uptake of cost-effective new technologies and prevent the uptake of technologies that are of doubtful value for the health system. It is one of three complementary functions to ensure the appropriate introduction and use of health technology. The other two components are regulation, which is concerned with safety and efficacy, and assessment of all significant intended as well as unintended consequences of technology use; and management, which is concerned with the procurement and maintenance of the technology during its life-cycle. The performance of health systems is strengthened when the linkages and exchange among these elements are clearly differentiated but mutually supportive. This document integrates health technology assessment into the WHO framework for evidence-informed policy-making. Health systems are strengthened when HTA is integrated into the human and material resources, data, transparent decision- and policy-making, and linked to the overall vision of equity and accountability. Good governance can rely on health technology assessment to provide a policy approach that is accountable for its decisions to the population.

Safety Evaluation in the Development of Medical Devices and Combination Products Third Edition

Safety Evaluation in the Development of Medical Devices and Combination Products  Third Edition Book
Author : Shayne C. Gad,Marian G. McCord
Publisher : CRC Press
Release : 2008-10-20
ISBN : 1439809488
Language : En, Es, Fr & De

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Book Description :

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.

Energy Efficiency of Medical Devices and Healthcare Applications

Energy Efficiency of Medical Devices and Healthcare Applications Book
Author : Amr Mohamed
Publisher : Academic Press
Release : 2020-02-15
ISBN : 0128190469
Language : En, Es, Fr & De

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Book Description :

Energy Efficiency of Medical Devices and Healthcare Facilities provides comprehensive coverage of cutting-edge, interdisciplinary research, and commercial solutions in this field. The authors discuss energy-related challenges, such as energy-efficient design, including renewable energy, of different medical devices from a hardware and mechanical perspectives, as well as energy management solutions and techniques in healthcare networks and facilities. They also discuss energy-related trade-offs to maximize the medical devices availability, especially battery-operated ones, while providing immediate response and low latency communication in emergency situations, sustainability and robustness for chronic disease treatment, in addition to high protection against cyber-attacks that may threaten patients’ lives. Finally, the book examines technologies and future trends of next generation healthcare from an energy efficiency and management point of view, such as personalized or smart health and the Internet of Medical Things — IoMT, where patients can participate in their own treatment through innovative medical devices and software applications and tools. The books applied approach makes it a useful resource for engineering researchers and practitioners of all levels involved in medical devices development, healthcare systems, and energy management of healthcare facilities. Graduate students in mechanical and electric engineering, and computer science students and professionals also benefit. Provides in-depth knowledge and understanding of the benefits of energy efficiency in the design of medical devices and healthcare networks and facilities Presents best practices and state-of-art techniques and commercial solutions in energy management of healthcare networks and systems Explores key energy tradeoffs to provide scalable, robust, and effective healthcare systems and networks

Safety Evaluation in the Development of Medical Devices and Combination Products Third Edition

Safety Evaluation in the Development of Medical Devices and Combination Products  Third Edition Book
Author : Shayne C. Gad,Marian G. McCord
Publisher : CRC Press
Release : 2008-10-20
ISBN : 9781420071641
Language : En, Es, Fr & De

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Book Description :

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.

Promoting Access to Medical Technologies and Innovation Intersections between Public Health Intellectual Property and Trade

Promoting Access to Medical Technologies and Innovation   Intersections between Public Health  Intellectual Property and Trade Book
Author : World Intellectual Property Organization
Publisher : WIPO
Release : 2013
ISBN : 9280523082
Language : En, Es, Fr & De

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Book Description :

This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.

Sterilisation of Biomaterials and Medical Devices

Sterilisation of Biomaterials and Medical Devices Book
Author : Sophie Lerouge,Anne Simmons
Publisher : Elsevier
Release : 2012-09-27
ISBN : 0857096265
Language : En, Es, Fr & De

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Book 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. 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