This book discusses the social control of new biomedical technologies and the problems in organization and delivery of medical care in the face of new technological and social change.

This book discusses the social control of new biomedical technologies and the problems in organization and delivery of medical care in the face of new technological and social change.

This publication addresses the role of the biomedical engineer in the development, regulation, management, training, and use of medical devices. The first part of the book looks at the biomedical engineering profession globally as part of the health workforce: global numbers and statistics, professional classification, general education and training, professional associations, and the certification process. The second part addresses all of the different roles that the biomedical engineer can have in the life cycle of the technology, from research and development, and innovation, mainly undertaken in academia; the regulation of devices entering the market; and the assessment or evaluation in selecting and prioritizing medical devices (usually at national level); to the role they play in the management of devices from selection and procurement to safe use in healthcare facilities. The annexes present comprehensive information on academic programs, professional societies, and relevant WHO and UN documents related to human resources for health as well as the reclassification proposal for ILO. This publication can be used to encourage the availability, recognition, and increased participation of biomedical engineers as part of the health workforce, particularly following the recent adoption of the recommendations of the UN High-Level Commission on Health Employment and Economic Growth, the WHO Global Strategy on Human Resources for Health, and the establishment of national health workforce accounts. The document also supports the aim of reclassification of the role of the biomedical engineer as a specific engineer that supports the development, access, and use of medical devices within the national, regional, and global occupation classification system.

Biomedical Innovations to Combat COVID-19 provides an updated overview on the development of vaccines, antiviral drugs and nanomaterials, and diagnostic methods for the fight against COVID-19. Perspectives on such technologies are identified, discussed, and enriched with figures for easy understanding and applicability. Furthermore, it contains basic aspects of virology, immunology, and antiviral drugs that are needed to fully appreciate these innovations. This book is split into four sections: introduction, presenting basic virologic and epidemiological aspects of COVID-19; vaccines against COVID-19, discussing their different types and applications used to develop them; diagnostic approaches for SARS-CoV-2, encompassing advanced sensing and microfluidic-based biosensors; and drug development and delivery, where antivirals based on nanomaterials or drugs are presented. It is a valuable source for virologists, biotechnologists, and members of biomedical field interested in learning more about how novel technologies can be applied to fasten the eradication of the COVID-19 and similar pandemics. - Presents updated literature coverage summarizing the most relevant information on COVID-19 - Written by experts from diverse scientific domains in order to provide readers with a thorough view on the subject - Encompasses tables, figures and information trees especially developed for the book in order to condense and highlight key points for quick reference

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.

The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

One of America’s top physicians traces the history of risk in medicine—with powerful lessons for today Every medical decision—whether to have chemotherapy, an X-ray, or surgery—is a risk, no matter which way you choose. In You Bet Your Life, physician Paul A. Offit argues that, from the first blood transfusions four hundred years ago to the hunt for a COVID-19 vaccine, risk has been essential to the discovery of new treatments. More importantly, understanding the risks is crucial to whether, as a society or as individuals, we accept them. Told in Offit’s vigorous and rigorous style, You Bet Your Life is an entertaining history of medicine. But it also lays bare the tortured relationships between intellectual breakthroughs, political realities, and human foibles. Our pandemic year has shown us, with its debates over lockdowns, masks, and vaccines, how easy it is to get everything wrong. You Bet Your Life is an essential read for getting the future a bit more right.

This book presents the latest developments in the field of biomedical engineering and includes practical solutions and strictly scientific considerations. The development of new methods of treatment, advanced diagnostics or personalized rehabilitation requires close cooperation of experts from many fields, including, among others, medicine, biotechnology and finally biomedical engineering. The latter, combining many fields of science, such as computer science, materials science, biomechanics, electronics not only enables the development and production of modern medical equipment, but also participates in the development of new directions and methods of treatment. The presented monograph is a collection of scientific papers on the use of engineering methods in medicine. The topics of the work include both practical solutions and strictly scientific considerations expanding knowledge about the functioning of the human body. We believe that the presented works will have an impact on the development of the field of science, which is biomedical engineering, constituting a contribution to the discussion on the directions of development of cooperation between doctors, physiotherapists and engineers. We would also like to thank all the people who contributed to the creation of this monograph—both the authors of all the works and those involved in technical works.

This thought-provoking study examines the ethical, legal, and social problems that arise with cutting-edge medical technology. Using as examples four powerful and largely unregulated technologies—off-label use of drugs, innovative surgery, assisted reproduction, and neuroimaging—Margaret L. Eaton and Donald Kennedy illustrate the difficult challenges faced by clinicians, researchers, and policy makers who seek to advance the frontiers of medicine safely and responsibly. Supported by medical history and case studies and drawing on reports from dozens of experts, the authors address important practical, ethical, and policy issues. They consider topics such as the responsible introduction of new medical products and services, the importance of patient consent, the extent of the duty to mitigate harm, and the responsibility to facilitate access to new medical therapies. This work's insights into the nature and consequences of medical innovation contribute to the national debate on how best to protect patients while fostering innovation and securing benefits.