| Description |
1 online resource |
| Contents |
Front Cover -- Safety Risk Management for Medical Devices -- Copyright Page -- Dedication -- Contents -- List of figures -- List of tables -- About the author -- Preface -- Acknowledgments -- 1 Introduction -- 1.1 History of Risk Management -- 2 What Is a Medical Device? -- 3 Why Do Risk-Management? -- 3.1 Legal and Regulatory Requirements -- 3.1.1 United States -- 3.1.2 European Union -- 3.1.3 MDD/AIMDD and Transition to EU MDR -- 3.2 Business Reasons -- 3.2.1 Cost Efficiency -- 3.2.2 Avoiding Recalls and Field Corrective Actions -- 3.2.3 Better Communications -- 3.3 Moral and Ethical Reasons -- 4 The Basics -- 4.1 Vocabulary of Risk Management -- 4.1.1 Reasonably Foreseeable Misuse -- 4.2 Hazard Theory -- 4.3 Systems and System Types -- 5 Understanding Risk -- 5.1 Risk Definitions -- 5.2 Types of Risk -- 5.3 Contributors to Risk -- 5.4 Risk Perception -- 5.5 Risk Computation -- 6 Risk Management Standards -- 6.1 ISO 14971 History and Origins -- 6.2 Harmonized Standards -- 7 Requirements of the Risk Management Process -- 7.1 Risk Management Process -- 7.1.1 Risk Analysis -- 7.1.1.1 Hazard Identification -- 7.1.1.2 Risk Estimation -- 7.1.2 Risk Evaluation -- 7.1.3 Risk Control -- 7.1.3.1 Risk Control Verification -- 7.1.4 Evaluation of Overall Residual Risk -- 7.1.5 Risk Management Review -- 7.1.6 Production and Post-Production Activities -- 8 Quality Management System -- 9 Usability Engineering and Risk Analysis -- 9.1 Key Terms -- 9.2 Distinctions -- 9.3 User-Device Interaction Model -- 9.4 Use Errors -- 9.5 Environmental Factors -- 9.6 Design Means to Control Usability Risks -- 9.7 Task Analysis -- 9.8 Usability and Risk -- 9.8.1 Elimination of Hazardous Situation -- 9.8.2 Data Gathering -- 9.8.3 Risk Reduction and Compliance with IEC 62366 Process -- 10 Biocompatibility and Risk Management -- 11 Influence of Security on Safety |
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12 The BXM Method -- 12.1 System Decomposition -- 12.2 Integration -- 12.3 Quantitative Risk Estimation -- 13 Risk Management Process -- 13.1 Management Responsibilities -- 13.1.1 Policy for Establishing Risk Acceptance Criteria -- 13.2 Risk Management File -- 13.3 Risk Management Plan -- 13.3.1 Criteria for Risk Acceptability -- 13.3.2 Other Considerations for Risk Reduction End-Point -- 13.4 Hazard Identification -- 13.5 Clinical Hazards List -- 13.6 Exceptions to the CHL -- 13.7 Harms Assessment List -- 13.7.1 How to Create a HAL -- Method 1 -- Using Published Scientific Papers -- Method 2 -- Using Expert Opinion -- 14 Risk Analysis Techniques -- 14.1 Fault Tree Analysis -- 14.1.1 Introduction -- 14.1.2 Theory -- 14.1.2.1 Primary, Secondary, and Command Faults -- 14.1.2.2 Immediate, Necessary, and Sufficient -- 14.1.2.3 State of Component -- State of System -- 14.1.2.4 Common Cause Failures -- 14.1.3 Symbols -- 14.1.4 Methodology -- 14.1.5 Ground Rules -- 14.1.5.1 Write Faults as Faults -- 14.1.5.2 No Gate-to-Gate Connections -- 14.1.5.3 Mark Low-Likelihood Faults as Basic Events -- 14.1.5.4 Don't Model Passive Components -- 14.1.5.5 Be Judicious in Modeling Secondary Faults -- 14.2 Mind Map Analysis -- 14.2.1 Introduction -- 14.2.2 Theory -- Methodology -- 14.3 Preliminary Hazard Analysis -- 14.3.1 Introduction -- 14.3.2 Methodology -- 14.3.2.1 Safety Characteristics -- 14.3.2.2 Functional Failure Modes and Effects Analysis -- 14.3.2.3 Identify System Hazards -- 14.4 Failure Modes and Effects Analysis -- 14.4.1 Facilitation of FMEAs -- 14.4.2 Hierarchical Multi-Level FMEA -- 14.4.3 Failure Theory -- 14.4.4 Ground Rules -- 14.4.5 Criticality Ranking -- 14.4.6 Benefits of FMEA -- 14.4.7 FMEA Weaknesses -- 14.4.8 Ownership of FMEA -- 14.4.9 Deciding When to Perform an FMEA -- 14.4.10 Making Your Way Through the FMEA -- 14.4.11 Revisiting FMEAs |
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14.5 FMEA in the context of Risk Management -- 14.6 Design Failure Modes and Effects Analysis (DFMEA) -- 14.6.1 DFMEA Workflow -- 14.6.1.1 Set Scope -- 14.6.1.2 Interface Matrix -- 14.6.1.3 Identify Primary and Secondary Functions -- 14.6.1.4 Analyze -- 14.7 Process Failure Modes and Effects Analysis (PFMEA) -- 14.7.1 PFMEA Workflow -- 14.7.1.1 Set Scope -- 14.7.1.2 Identify Primary and Secondary Functions -- 14.7.1.3 Process Flow Diagram -- 14.7.1.4 Analyze -- 14.8 Use/Misuse Failure Modes and Effects Analysis (UMFMEA) -- 14.8.1 Distinctions -- 14.8.2 Use Specification vs. Intended Use -- 14.8.3 UMFMEA Workflow -- 14.8.3.1 Set Scope -- 14.8.3.2 Identify Primary and Secondary Functions -- 14.8.3.3 Analyze -- 14.9 P-Diagram -- 14.9.1 Input Signals -- 14.9.2 System -- 14.9.3 Control Factors -- 14.9.4 Noise Factors -- 14.9.5 Ideal Function -- 14.9.6 Error States -- 14.9.7 Workflow -- 14.10 Comparison of FTA, FMEA -- 15 Software Risk Management -- 15.1 Software Types -- 15.2 Software Risk Analysis -- 15.2.1 Does Software Fail 100% of the Time? -- 15.3 Software FMEA (SFMEA) -- 15.3.1 SFMEA Workflow -- 15.4 Software Safety Classification -- 15.5 The BXM Method for Software Risk Analysis -- 15.5.1 Case 1 -- Probability of Software Failure Is Available -- 15.5.2 Case 2 -- Probability of Software Failure Is Not Available -- 15.6 Risk Management File Additions -- 15.7 Risk Controls -- 15.8 Legacy Software -- 15.9 Software of Unknown Provenance -- 15.10 Software Maintenance and Risk Management -- 15.11 Software Reliability vs. Software Safety -- 15.12 Tips for Developing Safety-Critical Software -- 16 Integration of Risk Analysis -- 16.1 Hierarchical Multi-Level FMEA -- 16.2 Integration of Supplier Input into Risk Management -- 17 Risk Estimation -- 17.1 Qualitative Method -- 17.2 Semi-Quantitative Method -- 17.3 Quantitative Method |
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17.4 Individual and Overall Residual Risks -- 17.5 Pre/Post Risk -- 17.6 Risks That Cannot Be Estimated -- 18 Risk Controls -- 18.1 Single-Fault-Safe Design -- 18.2 Risk Control Option Analysis -- 18.3 Distinctions of Risk Control Options -- 18.4 Information for Safety as a Risk Control Measure -- 18.4.1 Criteria for Information for Safety -- 18.5 Distinction of Types of Information for Safety -- 18.6 Sample Risk Controls -- 18.7 Risk Controls and Safety Requirements -- 18.8 Completeness of Risk Controls -- 19 Verification of Risk Controls -- 19.1 Verification of Implementation -- 19.2 Verification of Effectiveness -- 20 On Testing -- 20.1 Types of Testing -- 20.2 Risk-Based Sample Size Selection -- 20.3 Attribute Testing -- 20.4 Variable Testing -- 21 Risk Evaluation -- 21.1 Application of Risk Acceptance Criteria -- 21.1.1 How to Determine the State-of-the-Art -- 21.2 Risk Evaluation for Qualitative Method -- 21.3 Risk Evaluation for Semi-Quantitative Method -- 21.4 Risk Evaluation for Quantitative Method -- 22 Risk Assessment and Control Table -- 22.1 RACT Workflow -- 22.1.1 Examine the CHL -- 22.1.2 Capture End-Effects with Safety Impact -- 22.1.3 Revisit the PHA -- 22.1.4 Populate the Initial Cause and Sequence of Events Columns -- 22.1.5 Populate Hazardous Situations Column -- 22.1.6 Populate the P1 Column -- 22.1.7 Populate the Risk-Controls Columns -- 22.1.8 Populate the Harm Column -- 22.1.9 Populate the P2 Columns -- 22.1.10 Compute Residual Risks -- 22.1.11 Risk Evaluation -- 22.2 Individual and Overall Residual Risks -- 22.3 Inherent Risks -- 23 Benefit-Risk Analysis -- 23.1 What Is a Benefit? -- 23.2 Balancing Benefits against Risks -- 23.3 Benefit-Risk Analysis in Clinical Studies -- 24 Risk Management Review -- 25 Production and Post-Production Activities -- 25.1 Regulatory Basis -- 25.2 The Purpose of Post-Market Activities |
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25.3 Post-Market Risk Management -- 25.4 The Elements of Post-Market Risk Management -- 25.4.1 Post-Market Surveillance -- 25.4.1.1 Post-Market Surveillance Plan -- 25.4.1.2 Post-Market Surveillance System -- 25.4.1.3 Information Collection -- 25.4.1.4 Information Review -- 25.4.1.5 Consequent Actions -- 25.4.2 Post-Market Clinical Follow-up -- 25.4.2.1 PMCF Plan -- 25.4.2.2 PMCF Report -- 25.4.3 Complaint Handling and Monitoring -- 25.4.4 Post-Market Risk Management Actions -- 25.4.4.1 Corrective and Preventive Actions -- 25.4.4.2 Field Safety Corrective Actions -- 25.5 Deliverables of Post-Market Risk Management -- 25.5.1 Summary of Safety and Clinical Performance -- 25.5.2 Periodic Safety Update Report -- 25.5.3 Post-Market Surveillance Report -- 25.5.4 Manufacturer Incident Report -- 25.5.5 Medical Device Reporting -- 25.6 Clinical Evaluation -- 25.6.1 Clinical Evaluation Plan -- 25.6.2 Clinical Evaluation Report -- 25.6.2.1 CER Template Structure -- 25.7 Frequency of Risk Management File Review -- 25.8 Feedback to Pre-Market Risk Management -- 25.9 Benefits of Post-Market Surveillance -- 26 Traceability -- 27 Lifetime of a Medical Device -- 28 Safety Versus Reliability -- 29 Risk Management for System of Systems -- 29.1 Definition of System of Systems -- 29.2 Direct and Indirect Harms -- 29.3 Assessment of the Risks of an SoS -- 30 Risk Management for Clinical Investigations -- 30.1 Terminology -- 30.2 Clinical Studies -- 30.3 Mapping of Risk Management Terminologies -- 30.4 Risk Management Requirements -- 30.5 Adverse Event Categorization -- 30.6 Risk Documentation Requirements -- 30.7 Information Flow Between ISO 14971 and ISO 14155 -- 31 Risk Management for Legacy Devices -- 32 Risk Management for Combination Medical Devices -- 33 Basic Safety and Essential Performance -- 33.1 How to Identify Basic Safety |
| Summary |
Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations |
| Bibliography |
Includes bibliographical references and index |
| Subject |
Medical instruments and apparatus industry -- Risk management
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| Form |
Electronic book
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| ISBN |
9780323918237 |
|
0323918239 |
|
0323857558 |
|
9780323857550 |
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