Medical Devices: Improving Health Care Through a Multidisciplinary Approach

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. Readers will 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. Foreword Introduction Contents Contributors Abbreviations Part I: Opening Thoughts Chapter 1: The Medical Devices Promise to the Healthcare System 1.1 The Medical Devices Technology: A Preliminary Definition 1.2 The Main Challenge 1.3 A Possible Answer 1.4 The System Thinking References Chapter 2: The Role of the Engineer and Technology in Healthcare 2.1 Medical Devices, Experiences Skills, Customer Needs and Ethical Impacts 2.2 Challenging Issues for Engineers: Reliability of Medical Device Testing 2.2.1 The Problem 2.2.2 Reasons and Explanations 2.2.3 Boundary Conditions for Optimal Testing 2.2.4 Conclusion on Testing 2.3 Challenging Issues for Engineers: Medical Devices and Extractables 2.3.1 How are Extractables Defined? 2.3.2 Case Report on an Artificial Hip 2.3.3 Observations from Experiences on Haemodialysis Treatments 2.3.4 Examples for Adverse Clinical Effects in Patients 2.3.5 Conclusion on Extractables 2.4 Challenging Issues for Engineers: Medical Devices and Biocompatibility 2.4.1 Thrombogenicity and Blood Coagulation 2.4.2 Stimulation of the Immune System (Complement- and Cell-Activation) 2.4.3 Hypersensitivity Reactions 2.4.4 Haemodynamic and Vasoactive Effects 2.4.5 Conclusion on Biocompatibility References Chapter 3: Essentials of Innovation Theory for Medical Devices 3.1 Healthcare Innovation 3.1.1 Presentation of the Problem 3.1.2 Innovation Management as an Approach to Solution 3.2 Model of Innovation Adoption 3.2.1 Overview 3.2.2 Example of Application: Implant Technology Product Idea Development Certification and Market Approval Reimbursement Market Introduction and Idoption Feedback Loops Basic Innovations vs. Adaptions References Sources of Law Part II: Definitions and Regulations Chapter 4: Definition and International Regulations for Medical Devices 4.1 The Medical Device Concept and Classification 4.1.1 Definition of Medical Device in Europe 4.1.2 Definition of Medical Device in the United States 4.1.3 Definition of Medical Device in Japan 4.2 Regulations (EU, USA, Japan) 4.2.1 European Regulatory Framework: CE-Mark 4.2.2 CE-Mark Device Classification 4.2.3 Major Changes Introduced by the MDR 4.2.4 CE-Mark Certification and Declaration of Conformity 4.3 US Regulatory Framework: FDA Notification and Approval 4.3.1 FDA Device Classification 4.3.2 FDA Premarket Approval and Premarket Notification Process 4.4 Japanese PMDA 4.4.1 Japan Medical Device Classification 4.4.2 PMDA Process 4.5 International Technical Standards 4.5.1 Harmonized Standards in Europe 4.5.2 Harmonized Standards in the USA References Chapter 5: Lifecycle of Medical Devices 5.1 Medical Devices Lifecycle: WHO Definition, Main Phases, and Stakeholders 5.1.1 Phase 1: Conception and Development 5.1.2 Phase 2: Manufacturing 5.1.3 Phase 3: Packaging and Labelling 5.1.4 Phase 4: Advertising 5.1.5 Phase 5: Sale 5.1.6 Phase 6: Use 5.1.7 Phase 7: Disposal 5.2 Regulatory Requirements 5.2.1 Conception and Development: Harmonized/Consensus Standards 5.2.2 Manufacturing: Good Manufacturing Practice and Quality Management System 5.2.3 Packaging and Labelling: Information to Report and Symbols to Use 5.2.4 Advertising: Local Laws and Truthful Statements 5.2.5 Sales: Responsibility of Manufacturers, Distributors, and Importers 5.2.6 Use: Correct Information to the User and Post-market Surveillance 5.3 A Case-Study: Development of a Device for Cardiac Arrhythmia Detection, for Personal Use 5.3.1 Conception and Development: From the Idea to the First Prototype The Clinical Need Unmet The Idea of the Device The Context The Competitors The Requirements The Prototyping 5.3.2 Manufacturing: Choice of Suppliers and Mass Production 5.3.3 Packaging and Labelling: A Compromise between Regulatory Restriction and Brand Message 5.3.4 Advertising: The Target is the Patient 5.3.5 Sale: Distribution Network and Personnel Training 5.3.6 Use: Attention to Possible Misuses and Customers Reviews References Part III: Engineering and Operations Chapter 6: The Medical Devices in Healthcare Provider Organisations 6.1 Setting the Issue 6.1.1 Healthcare Technology and Medical Devices 6.1.2 The Quality in HPO 6.2 The Role of the Infrastructure 6.2.1 Acquisition 6.2.2 Utilisation 6.2.3 Reprocessing 6.3 Impact on the Healthcare Processes 6.3.1 The Concept of Risk in Medical Devices A Risk Is Not a Disease 6.3.2 The Risk Management Activity in HPO 6.4 A Possible Paradigm: The Case of Blood Purification with Haemodialysis 6.4.1 Short Intro 6.4.2 Operations 6.4.3 Infrastructure 6.5 Additional Considerations for Low-Income Countries References Chapter 7: Information and Communication Technology: Implications on Patient´s Privacy and Security 7.1 The Present Status 7.2 EU: The General Data Protection Regulation (GDPR) 7.2.1 Pseudonymization and Encryption 7.2.2 The Right to be Forgotten 7.3 EU: Information Security and IT for Medical Devices 7.4 The USA: The Health Information Portability and Accountability Act References Part IV: Apply Economics in Medicine Chapter 8: Economic Perspectives: An Overview 8.1 Systems Approach 8.2 Costs 8.3 Outputs, Outcomes, and Impacts 8.4 Performance 8.5 Period References Chapter 9: Assessment of Medical Technologies: Methods and Challenges 9.1 The Concept of ``Value´´ in Healthcare 9.1.1 Value-based Healthcare and Technology Assessment 9.1.2 Health Technology Assessment 9.1.3 Economic Assessment of Technology in Healthcare 9.1.4 Cost-Utility Analysis 9.1.5 Multi-criteria Decision Analysis Equation (9.1): Determination of Value According to MCDA 9.1.6 Social Return on Investment (SROI) in Healthcare 9.2 Disinvesting for Investing in Healthcare 9.3 Technology Assessment in Hospitals 9.3.1 The Linkage Between Technology Assessment and Hospital Strategy 9.3.2 The Organizational Arrangements for Technology Assessment in Hospitals 9.3.3 Frameworks for Technology Assessment in Hospitals 9.3.4 Acceptance of Innovation in Hospitals 9.3.5 Government of Technology Assessment in Hospitals References Chapter 10: Reimbursement Systems for Healthcare: Considerations on ``Pay for Performance´´ 10.1 Pay-for Performance and Clinical Therapies 10.1.1 Pay-for-Performance (P4P) Programs 10.1.2 Determining Factors for the Introduction of P4P Programs 10.1.3 Motivation of Involved Stakeholders and Their Possible Conflict of Interest Patients as Stakeholders Physicians as Stakeholders Hospital Management as a Stakeholder Health Insurance Funds as Stakeholders 10.1.4 Case Report: The P4P System in the United Kingdom 10.1.5 Results: General Observations 10.1.6 Results: Improvements in Clinical Quality Indicators 10.1.7 Lessons Learned from QOF Daily Practice 10.2 Performance and Compensations for Medical Devices 10.2.1 Trends and Observations in the Global Medical Device Market 10.2.2 Innovative Products for the Reduction of Total Cost of Care 10.2.3 Adaptation to Different Requirements of International Healthcare Systems by Innovative Processes References Part V: Problems and Opportunities Chapter 11: The Role of Medical Devices in Healthcare Sustainability 11.1 The Healthcare System Sustainability and Its Enemies 11.2 Health Care Systems Sustainability and the Impact of Medical Devices 11.2.1 Pollution Control and Resources Saving 11.2.2 Active Contribution of Medical Devices to Sustainability References Chapter 12: Medical Devices in Low- and Middle-Income Countries 12.1 Many Worlds of Health 12.1.1 Classification 12.1.2 Characteristics of Health and Healthcare in Low- and Middle-Income Countries 12.2 Applied Technology 12.3 Emerging Markets: Markets of the Future 12.3.1 Economic Growth: The New Tigers 12.3.2 Social Insurance 12.3.3 Aging Population and Urbanization References Chapter 13: Ethical Aspects in Medical Devices and Ethical Committees in Clinical Trials and Regulations 13.1 Clinical Trials for Medicinal Products (Pharmaceutical Drugs) 13.2 Clinical Trials on Medical Devices and In Vitro Diagnostics Medical Devices 13.2.1 The New Regulations on MD in a Nutshell 13.3 Regulation (EU) No. 2017/745 13.3.1 Classification of Devices and Conformity Assessment Procedures 13.4 Key Aspects of the New Medical Device Regulation (MDR) 13.4.1 Quality Management System (QMS) 13.5 Ethical Aspects and Ethical Committees 13.5.1 Ethical, Scientific and Methodological Evaluation of Clinical Studies 13.5.2 European Regulation on Clinical Trials: Towards the Harmonisation of Standards on Clinical Trials References Chapter 14: Medical Devices in Healthcare: Where We Are and Where We Are Going 14.1 The Questions 14.2 The Role of Technology 14.3 System Approach References