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Safety risk management for medical devices /
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 sens...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Amsterdam :
Academic Press,
[2022]
|
| Edición: | Second edition |
| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- 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.
- 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.
- 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.
- 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.
- 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.