legal basis of global tissue banking a proactive clinical perspective

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Legal Basis Of Global Tissue Banking

Author : Glyn O Phillips
ISBN : 9789814663458
Genre : Medical
File Size : 21. 62 MB
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The banking of human tissues for clinical transplantation has grown exponentially in the past 10-15 years. Tissue banks have been set up throughout the world, initially on an ad hoc basis. More recently these have grown and in many countries have linked up with larger international companies. While standards for the procurement, processing and storage of the tissues have kept pace with the growth of the subject, this is not so with the legal considerations associated with the practice. There is no unified legal system which is internationally operated. Europe, USA, Asia, Latin America, China have been developing legal systems on an individual basis. This book describes the present state of the development of laws to control and make the banking and use of tissues legal and safe. It describes, for the first time, the current systems which are used throughout the world and points the way to setting up a harmonized global legal system. Contents:Introduction: From a Cottage Industry to a Global Business (Glyn O Phillips)Legal Framework for International Operation of Tissue Banks (Peter Myint)The Legal and Regulatory Framework for Tissues and Cells in the European Union (Deborah R Hutchison)Litigation Risks Facing Tissue Banks in the United States (Daniel D Harshman)The Importance of a Code of Ethics and a Code of Practice for Tissue Establishments (Jorge Morales Pedraza)Ethical, Religious, Legal, and Cultural Issues for Tissue Banking, with Special Reference to the Asia-Pacific Region (Aziz Nather and Wee Lin)Challenges for Tissue Banking in the Asia-Pacific Region and Recent Progress in Malaysia (Norimah Yusof)Legal System for Tissue Banking in Latin America (Eulogia Kairiyama)Establishing a Legal System for Tissue Banking in China (Li Bao Xing, Zhao Yaping and Glyn O Phillips)Independence for Wales from the Remainder of the United Kingdom: A Change from Informed Consent to Presumed Consent (Glyn O Phillips)Germany: Regulation of Tissues and Tissue Banking — A Special Case (Peter Hergert and Ralf R Tönjes)Legal Issues Associated with Producing and Marketing Tissues Internationally (Caroline A Hartill)A Retrospective Look at the Largest Recall of Processed Bone Tissue in History (Helena Lazares and John T Salvucci)Polymethyl Methacrylate: An Acceptable Material for Tissue Augmentation and Reconstruction (Mario Cabraja, Jack Klecan and Glyn O Phillips) Readership: Ethicists, lawyers, policymakers, clinicians, healthcare professionals, stem cell scientists, researchers and academics in bioethics, and general public. Key Features:China practices are opened up for the first time to the WestThe European highly complex systems are described clearly and succinctly which may make the system understandable even to the European CommissionWales will change its legal system of tissue procurement and its difference from the remainder of the UK is describedGermany is a special case in Europe and is authoritatively coveredThere is a description of probably the most notable tissue banking litigation in the USAThe pioneering global work of the International Atomic Agency in setting basic systems in place is describedThe influence of religious belief on tissue and legal practices is also coveredKeywords:Tissue Banking;Transplantation;Tissue Law;Procurement;Commercial Tissues;Tissue Laws in China;Asia;Latin America;Europe and USA

Legal Basis Of Global Tissue Banking

Author : Glyn O. Phillips
ISBN : 9814663433
Genre : Law
File Size : 25. 36 MB
Format : PDF, Docs
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The banking of human tissues for clinical transplantation has grown exponentially in the past 10-15 years. Tissue banks have been set up throughout the world, initially on an ad hoc basis. More recently these have grown and in many countries have linked up with larger international companies. While standards for the procurement, processing and storage of the tissues have kept pace with the growth of the subject, this is not so with the legal considerations associated with the practice. There is no unified legal system which is internationally operated. Europe, USA, Asia, Latin America, China have been developing legal systems on an individual basis. This book describes the present state of the development of laws to control and make the banking and use of tissues legal and safe. It describes, for the first time, the current systems which are used throughout the world and points the way to setting up a harmonized global legal system.

Biomaterials And Medical Devices

Author : Ferdiansyah Mahyudin
ISBN : 9783319148458
Genre : Technology & Engineering
File Size : 78. 32 MB
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This book presents an introduction to biomaterials with the focus on the current development and future direction of biomaterials and medical devices research and development in Indonesia. It is the first biomaterials book written by selected academic and clinical experts experts on biomaterials and medical devices from various institutions and industries in Indonesia. It serves as a reference source for researchers starting new projects, for companies developing and marketing products and for governments setting new policies. Chapter one covers the fundamentals of biomaterials, types of biomaterials, their structures and properties and the relationship between them. Chapter two discusses unconventional processing of biomaterials including nano-hybrid organic-inorganic biomaterials. Chapter three addresses biocompatibility issues including in vitro cytotoxicity, genotoxicity, in vitro cell models, biocompatibility data and its related failure. Chapter four describes degradable biomaterial for medical implants, which include biodegradable polymers, biodegradable metals, degradation assessment techniques and future directions. Chapter five focuses on animal models for biomaterial research, ethics, care and use, implantation study and monitoring and studies on medical implants in animals in Indonesia. Chapter six covers biomimetic bioceramics, natural-based biocomposites and the latest research on natural-based biomaterials in Indonesia. Chapter seven describes recent advances in natural biomaterial from human and animal tissue, its processing and applications. Chapter eight discusses orthopedic applications of biomaterials focusing on most common problems in Indonesia, and surgical intervention and implants. Chapter nine describes biomaterials in dentistry and their development in Indonesia.

Cancer Clinical Trials Proactive Strategies

Author : Stanley P. L. Leong
ISBN : 9780387332253
Genre : Medical
File Size : 50. 25 MB
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Clinical trials remain the most important vehicle for improving the care of cancer patients. This text presents the fundamental components and challenges involving clinical investigations. Leading experts discuss the critical issues covering the spectrum of important topics from planning to application. The book has a foreword by Samuel A. Wells, Jr., MD, Professor of Surgery, Duke University Medical Center, Durham, NC, former Director of the American College of Surgeons and Founder of the American College of Surgeons Oncology Group.

Designing And Implementing Health Care Provider Payment Systems

Author : Jack Langenbrunner
ISBN : 9780821378243
Genre : Medical
File Size : 81. 82 MB
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Strategic purchasing of health services involves a continuous search for the best ways to maximize health system performance by deciding which interventions should be purchased, from whom these should be purchased, and how to pay for them. In such an arrangement, the passive cashier is replaced by an intelligent purchaser that can focus scarce resources on existing and emerging priorities rather than continuing entrenched historical spending patterns.Having experimented with different ways of paying providers of health care services, countries increasingly want to know not only what to do when paying providers, but also how to do it, particularly how to design, manage, and implement the transition from current to reformed systems. 'Designing and Implementing Health Care Provider Payment Systems: How-To Manuals' addresses this need.The book has chapters on three of the most effective provider payment systems: primary care per capita (capitation) payment, case-based hospital payment, and hospital global budgets. It also includes a primer on a second policy lever used by purchasers, namely, contracting. This primer can be especially useful with one provider payment method: hospital global budgets. The volume's final chapter provides an outline for designing, launching, and running a health management information system, as well as the necessary infrastructure for strategic purchasing.

Human Trafficking Human Misery

Author : Alexis A. Aronowitz
ISBN : 9780275994815
Genre : Social Science
File Size : 81. 52 MB
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This volume takes a global perspective and uses first-hand accounts and stories to examine the problem of human trafficking in its various manifestations around the world.

The Future Of Nursing

Author : Institute of Medicine
ISBN : 9780309208956
Genre : Medical
File Size : 51. 59 MB
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The Future of Nursing explores how nurses' roles, responsibilities, and education should change significantly to meet the increased demand for care that will be created by health care reform and to advance improvements in America's increasingly complex health system. At more than 3 million in number, nurses make up the single largest segment of the health care work force. They also spend the greatest amount of time in delivering patient care as a profession. Nurses therefore have valuable insights and unique abilities to contribute as partners with other health care professionals in improving the quality and safety of care as envisioned in the Affordable Care Act (ACA) enacted this year. Nurses should be fully engaged with other health professionals and assume leadership roles in redesigning care in the United States. To ensure its members are well-prepared, the profession should institute residency training for nurses, increase the percentage of nurses who attain a bachelor's degree to 80 percent by 2020, and double the number who pursue doctorates. Furthermore, regulatory and institutional obstacles -- including limits on nurses' scope of practice -- should be removed so that the health system can reap the full benefit of nurses' training, skills, and knowledge in patient care. In this book, the Institute of Medicine makes recommendations for an action-oriented blueprint for the future of nursing.

Bone Implant Grafting

Author : John Older
ISBN : 9781447119340
Genre : Medical
File Size : 52. 43 MB
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Surgeons differ in their enthusiasm for autografts, allografts and metallic implants, nevertheless, all have their place in orthopedic surgery. For some defects in the skeleton, bone grafting may be the only solution. The pros and cons of bone grafting are thoroughly discussed by eighteen distinguished authorities in this book. Their exchange of views and experiences reflects the diversity of thinking worldwide and points to exciting possibilities for future improvements. The twenty-eight chapters describe: the natural history and immunology of auto and allografting; innovative surgical techniques together with results, whether successful or not; and bone banking and its related problems, especially HIV.

Laboratory Quality Management System

Author : World Health Organization
ISBN : 9241548274
Genre : Medical
File Size : 66. 91 MB
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Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".

Risk Management Handbook For Health Care Organizations

Author : Roberta Carroll
ISBN : 9780470300176
Genre : Medical
File Size : 85. 39 MB
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Risk Management Handbook for Health Care Organizations, Student Edition is a complete introductory textbook on risk management in health care, incorporating all the basic elements of risk management as it relates to health care finance, quality, management, law, and regulatory compliance. In 24 concise chapters, this comprehensive introduction provides a perfect overview to prepare students, or working professionals in health care or law, enter the field of health care risk management and patient safety. Readers will be provided an understanding of general risk management techniques; standards of health care risk management administration; federal, state and local laws; and methods for integrating patient safety and enterprise risk management into a comprehensive risk management program. Each chapter will have key points, standardized introduction, list of key terms, and discussion questions. A separate downloadable instructors? manual will have additional support tools for the instructor. Chapter topics include: Enterprise Risk Management in Health Care ? The Basics Health Care Legal Concepts Governance of the Health Care Organization Development of a Risk Management Program The Health Care Risk Management Professional Risk Management Metrics Ethics in Patient Care Interpersonal Communication Skills: The Ultimate Loss Control Technique Physician and Allied Health Professionals Credentialing Documentation and the Medical Record Basic Claims Administration A Contract Review Primer for Risk Management Information Technologies and Risk Management Health Information Management Introduction to Risk Financing Insurance: Basic Principles and Coverages Organizational Staffing Emergency Management Occupational Safety , Health ad Environmental Impairment: A Brief Overview Early Warning Systems for the Identification Organizational Patient Safety and the Risk Management Professional Risk Management?s Role in Performance Improvement The Risk management Professional and Medication Safety

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