Full Description
This book provides caregivers and administrators with high-quality support for strategic decision making in the selection and use of medical devices so as to ensure value optimization. Medical treatment is increasingly complex, with wide application of medical devices and corresponding involvement of physics and engineering. A multidisciplinary methodology that brings together expertise from key disciplines in a holistic, system-oriented approach is essential in controlling this complexity and further improving health care. This book will help readers to understand the design, validation, and application of medical devices and the standards and regulations that apply to them across the world. In addition, it provides technical, operational, and economic perspectives on their use. The relevance of concepts such as expenditure optimization and sustainability to medical device technology is explained and healthcare reimbursement systems are discussed from different points of view. Readerswill gain a clear appreciation of the managerial and economic implications of the use of medical devices and how to get the most out of them. Academic research, industrial experiences, and case studies are presented as appropriate.
Contents
1. Introduction (CB, SC, JV).- 1.1 How the medical devices can add value and support the health systems worldwide for present and future challenges.- 2. Role of technology in Health Care (CB, JV).- Historical background: summary of the different approaches to medicine along the times.- The technology in medicine: from the stethoscope, to the WWI innovation, to the present.- The meaning of innovation in technology and medicine.- 3. Definition and international classification of Medical Devices (SC, JV, GC).- 3.1 The medical device concept.- Medical devices and pharmaceuticals: an important difference.- The rationale behind the definition.- 3.2 Standards and regulations (ISO, AAMI (USA), MHW (Japan), MDD (Europe)).- Description and comparison among the different standards.- The rationale behind the classification.- Evaluation of risks and benefits.- Focus on EU MDR.- The impacts of classification on design and operation of medical devices.- Remarks on in-vitro diagnostics and combinationproducts.- 3.3 ICT and patient's privacy.- 3.4 Ethical aspects.- 4. Technical and operational perspective (CB, JV).- 4.1 Typical lifecycle of a medical device.- 4.2 The impact of Medical Devices in the healthcare institution.- 4.3 The need for a systemic approach.- 5. Economic Perspective (EL, SF, MdV).- 5.1 Overview.- 5.2 Value in medicine.- 5.3 Reimbursement systems.- 6. Further challenges (CB, SC, JV, SF).- 6.1 Healthcare sustainability and consequences on medical devices technology.- 6.2 Medical devices in Developing Countries.- 7. Future outlook and conclusions (CB, SC, JV).
