| Description |
1 online resource |
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text txt rdacontent |
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computer c rdamedia |
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online resource cr rdacarrier |
| Note |
Online resource; title from PDF title page (EBSCO, viewed July 12, 2018). |
| Bibliography |
Includes bibliographical references and index. |
| Summary |
"Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction. This book delivers not only theory, but also practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971--a requirement for all medical devices. This book outlines sensible, easily comprehensible, and state-of the-art methodologies that are rooted in current industry best practices. Opening chapters introduce the concept of risk, the legal basis for risk management, and the requirements for a compliant risk-management process. The next group of chapters discusses the connection between risk management and quality systems, usability engineering and biocompatibility. This book delves into the techniques of risk management, such as fault tree analysis and failure modes and effects analysis, and continues with risk estimation, risk control, and risk evaluation. Special topics such as software risk management, clinical investigations, and security are also discussed. The latter chapters address benefit-risk analysis, and production and postproduction monitoring. This book concludes with advice and wisdom for sensible, efficient, and successful safety risk management of medical devices. Teaches industry best practices on medical-device risk management in compliance with ISO 14971Provides practical, easy-to-understand, and step-by-step instructions on how to perform hazard analysis and manage the risks of medical devicesOffers a worked-out example applying the risk management process on a hypothetical device"-- Provided by publisher |
| Contents |
Front Cover; Safety Risk Management for Medical Devices; Copyright Page; Dedication; Contents; List of Figures; List of Tables; Biography; Preface; 1 Introduction; 2 Why Do Risk Management?; 2.1 Legal and Regulatory Requirements; 2.1.1 United States; 2.1.2 European Union; 2.1.3 MDD/AIMDD and transition to EU MDR; 2.2 Business Reasons; 2.2.1 Cost efficiency; 2.2.2 Avoiding recalls and field corrective actions; 2.2.3 Better communications; 2.3 Moral and Ethical Reasons; 3 The Basics; 3.1 Vocabulary of Risk Management; 3.1.1 Further elaborations; 3.1.1.1 Reasonably foreseeable misuse |
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3.2 Hazard Theory3.3 System Types; 4 Understanding Risk; 4.1 Risk Definitions; 4.2 Types of Risk; 4.3 Contributors to Risk; 4.4 Risk Perception; 4.5 Risk Computation; 5 Risk Management Standards; 5.1 ISO 14971 History and Origins; 5.2 Harmonized Standards; 6 Requirements of the Risk Management Process; 6.1 Risk Management Process; 6.1.1 Risk analysis; 6.1.1.1 Hazard identification; 6.1.1.2 Risk estimation; 6.1.2 Risk evaluation; 6.1.3 Risk controls; 6.1.4 Risk control verification; 6.1.5 Monitoring; 7 Quality Management System; 8 Usability Engineering and Risk Analysis; 8.1 Key Terms |
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8.2 Distinctions8.3 User-Device Interaction Model; 8.4 Use Failures; 8.5 Environmental Factors; 8.6 Design Means to Control Usability Risks; 8.7 Task Analysis; 8.8 Usability and Risk; 8.8.1 Data gathering; 8.8.2 Risk reduction and compliance with IEC 62366 process; 9 Biocompatibility and Risk Management; 10 The BXM Method; 10.1 System Decomposition; 10.2 Integration; 10.3 Quantitative Risk Estimation; 11 Risk Management Process; 11.1 Management Responsibilities; 11.2 Risk Management File; 11.3 Risk Management Plan; 11.3.1 Criteria for risk acceptability |
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11.3.2 Other considerations for risk reduction end-point11.4 Hazard Identification; 11.5 Clinical Hazards List; 11.6 Harms Assessment List; 11.6.1 How to create a Harms Assessment List; 11.6.1.1 Method 1-Using published data; 11.6.1.2 Method 2-Using expert opinion; 12 Risk Analysis Techniques; 12.1 Fault Tree Analysis; 12.1.1 Introduction; 12.1.2 Theory; 12.1.2.1 Primary, secondary, and command Faults; 12.1.2.2 Immediate, necessary, and sufficient; 12.1.2.3 State of Component-State of System; 12.1.2.4 Common Cause Failures; 12.1.3 Symbols; 12.1.4 Methodology; 12.1.5 Ground rules |
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12.1.5.1 Write faults as faults12.1.5.2 No gate-to-gate connections; 12.1.5.3 Mark low-likelihood faults as Basic Events; 12.1.5.4 Don't model passive components; 12.1.5.5 Be judicious in modeling secondary faults; 12.2 Mind Map Analysis; 12.2.1 Introduction; 12.2.2 Theory; 12.2.3 Methodology; 12.3 Preliminary Hazard Analysis; 12.3.1 Introduction; 12.3.2 Methodology; 12.3.2.1 Safety characteristics; 12.3.2.2 Identify System Hazards; 12.4 Failure Modes and Effects Analysis; 12.4.1 Facilitation of FMEAs; 12.4.2 Hierarchical multilevel FMEA; 12.4.3 Failure theory; 12.4.4 Ground rules |
| Subject |
Medical instruments and apparatus industry -- Risk management.
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Médecine -- Appareils et instruments -- Industrie -- Gestion du risque.
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BUSINESS & ECONOMICS -- Industries -- General.
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| Other Form: |
Print version: 0128130989 9780128130988 (OCoLC)1017598518 |
| ISBN |
9780128130995 (electronic bk.) |
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0128130997 (electronic bk.) |
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9780128130988 |
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0128130989 |
| Standard No. |
AU@ 000063801624 |
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AU@ 000065065585 |
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GBVCP 1028101511 |
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UKMGB 018915822 |
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