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Safety risk management for medical devices
Author
Title
Safety risk management for medical devices / Bijan Elahi.
ISBN
9780323918237
0323918239
9780323857550
0323857558
9780323857550
Edition
Second edition
Publication
Amsterdam : Academic Press, [2022]
Physical Description
1 online resource
Local Notes
Access is available to the Yale community.
Access and use
Access restricted by licensing agreement.
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.
Variant and related titles
Knovel. OCLC KB.
Other formats
Print version:
Format
Books / Online
Language
English
Added to Catalog
August 07, 2023
Bibliography
Includes bibliographical references and index.
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.
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.
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