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Safety Risk Management for Medical Devices
- 2nd Edition - November 11, 2021
- Author: Bijan Elahi
- Language: English
- Paperback ISBN:9 7 8 - 0 - 3 2 3 - 8 5 7 5 5 - 0
- eBook ISBN:9 7 8 - 0 - 3 2 3 - 9 1 8 2 3 - 7
Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14… Read more
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Request a sales quoteSafety 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.
- Includes new coverage of ISO 14971:2019, ISO/TR 24971
- Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management
- Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation
Engineers and other professionals 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.
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
3.2 Business Reasons
3.3 Moral and Ethical Reasons
4 The Basics
4.1 Vocabulary of Risk Management
Reasonably Foreseeable Misuse
4.2 Hazard Theory
4.3 System 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
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
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
13.2 Risk Management File
13.3 Risk Management Plan
13.4 Hazard Identification
13.5 Clinical Hazards List
13.6 Harms Assessment List
14 Risk Analysis Techniques
14.1 Fault Tree Analysis
14.2 Mind Map Analysis
14.3 Preliminary Hazard Analysis
14.3.1 Introduction
14.3.2 Methodology
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
14.7 Process Failure Modes and Effects Analysis (PFMEA)
14.7.1 PFMEA Workflow
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
14.9 P‐Diagram
14.10 Comparison of FTA, FMEA
15 Software Risk Management
15.1 Software Types
15.2 Software Risk Analysis
15.3 Software FMEA (SFMEA)
15.4 Software Safety Classification
15.5 The BXM Method for Software Risk Analysis
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
18.5 Distinction of Types 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 (RACT)
22.1 RACT Workflow
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
25.4.2 Post‐Market Clinical Follow‐up (PMCF)
25.4.3 Complaint Handling and Monitoring
25.4.4 Post‐Market Risk Management Actions
25.5 Deliverables of Post‐Market Risk Management
25.5.1 Summary of Safety and Clinical Performance (SSCP)
25.5.2 Periodic Safety Update Report (PSUR)
25.5.3 Post‐Market Surveillance Report (PMSR)
25.5.4 Manufacturer Incident Report (MIR)
25.5.5 Medical Device Reporting (MDR)
25.6 Clinical Evaluation
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
30 Risk Management for Clinical Investigations
31 Risk Management for Legacy Devices
32 Risk Management for Combination Medical Devices
33 Basic Safety and Essential Performance
34 Relationship between ISO 14971 and other Standards
34.1 Interaction with IEC 60601‐1
34.2 Interaction with ISO 10993‐1
34.3 Interaction with IEC 62366
34.4 Interaction with ISO 14155
35 Risk Management Process Metrics
36 Risk Management and Product Development Process
36.1 Identification of Essential Design Outputs
36.2 Lifecycle Relevance of Risk Management
37 Risk Management for Suppliers
37.1 Manufacturer Perspective
37.2 Supplier Perspective
38 Axioms
39 Special Topics
39.1 The conundrum
39.2 Cassandras
39.3 Personal Liability
39.4 Creating a Safety Culture
39.5 Predicting the Future
40 Critical Thinking and Risk Management
41 Advice and Wisdom
Appendix A ‐ Glossary
Appendix B – Templates
B.1 DFMEA Template
B.2 SFMEA Template
B.3 PFMEA Template
B.4 UMFMEA Template
B.5 RACT Template
Appendix C – Example Device – Vivio
C.1 Vivio Product Description
C.2 Vivio Product Requirements
C.3 Vivio Architecture
C.4 Risk Management Plan
C.5 Clinical Hazards List
C.6 Harms Assessment List
C.7 Preliminary Hazard Analysis
C.8 Design Failure Modes and Effects Analysis (DFMEA)
C.9 Process Failure Modes and Effect Analysis (PFMEA)
C.10 Use/Misuse Failure Modes and Effects Analysis (UMFMEA)
C.11 Risk Assessment and Controls Table (RACT)
C.12 Full Body Report
C.13 Risk Management Report
Appendix D – Useful References
- No. of pages: 534
- Language: English
- Edition: 2
- Published: November 11, 2021
- Imprint: Academic Press
- Paperback ISBN: 9780323857550
- eBook ISBN: 9780323918237
BE
Bijan Elahi
Bijan Elahi is an expert on a world scale in safety risk management for medical technology. Mr. Elahi’s mission is to elevate knowledge and proficiency in medical device risk management to the highest levels worldwide via teaching, coaching, and mentoring, for the benefit of companies and society. He has 30+ years of experience in risk management, working with the largest medical device companies in the world, as well as with small start-ups. He is a lecturer at Eindhoven University of Technology (the Netherlands), where he teaches a graduate-level course in medical device risk management. The audience for this education is doctoral students in engineering as well as physicians and professionals in the medical device sector. Additionally, Mr. Elahi is a lecturer at Drexel University in Philadelphia (USA), and at Delft University of Technology (Netherlands). He is the recipient of the Educator of the Year Award by the International System Safety Society. In 2019 he received an award in recognition of Outstanding Development of Analytical Methods to Support Medical Device System Safety.
Mr. Elahi has a long history of medical device development spanning class III implantable pulse generators, electro-mechanical, and disposable devices. His most recent product was a Deep Brain Stimulator (DBS) implant for Parkinson’s disease. The knowledge that he imparts in his book is rooted in state-of-the-art practical knowledge in medical device development.
Mr. Elahi is a Technical Fellow and a corporate advisor at Medtronic. In this role, he teaches and consults on medical device risk management to all Medtronic business units worldwide, including China, India, Middle East, Europe and North America. Mr. Elahi is a contributor to ISO 14971, and a member of the Editorial Board of the Journal of System Safety, a publication of the International System Safety Society. Mr. Elahi is a frequently invited speaker and lecturer at international conferences. Earlier in his distinguished career, he was a systems engineer on the Space Shuttle at NASA (USA). Mr. Elahi holds an MS Electrical Engineering degree from the University of Washington and a BS Aerospace Engineering degree from Iowa State University, United States.
Affiliations and expertise
International Council on Systems Engineering (INCOSE), International System Safety Society (ISSS), European Institute of Innovation and Technology (EIT Health), FL, USARead Safety Risk Management for Medical Devices on ScienceDirect