Safety Risk Management for Medical Devices

2nd Edition - November 11, 2021
Imprint: Academic Press
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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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.

Cover image
Title page
Table of Contents
Copyright
Dedication
List of figures
List of tables
About the author
Preface
Acknowledgments
Chapter 1. Introduction
Abstract
1.1 History of Risk Management
Chapter 2. What Is a Medical Device?
Abstract
Chapter 3. Why Do Risk-Management?
Abstract
3.1 Legal and Regulatory Requirements
3.2 Business Reasons
3.3 Moral and Ethical Reasons
Chapter 4. The Basics
Abstract
4.1 Vocabulary of Risk Management
4.2 Hazard Theory
4.3 Systems and System Types
Chapter 5. Understanding Risk
Abstract
5.1 Risk Definitions
5.2 Types of Risk
5.3 Contributors to Risk
5.4 Risk Perception
5.5 Risk Computation
Chapter 6. Risk Management Standards
Abstract
6.1 ISO 14971 History and Origins
6.2 Harmonized Standards
Chapter 7. Requirements of the Risk Management Process
Abstract
7.1 Risk Management Process
Chapter 8. Quality Management System
Abstract
Chapter 9. Usability Engineering and Risk Analysis
Abstract
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
Chapter 10. Biocompatibility and Risk Management
Abstract
Chapter 11. Influence of Security on Safety
Abstract
Chapter 12. The BXM Method
Abstract
12.1 System Decomposition
12.2 Integration
12.3 Quantitative Risk Estimation
Chapter 13. Risk Management Process
Abstract
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 Exceptions to the CHL
13.7 Harms Assessment List
Chapter 14. Risk Analysis Techniques
Abstract
14.1 Fault Tree Analysis
14.2 Mind Map Analysis
14.3 Preliminary Hazard Analysis
14.4 Failure Modes and Effects Analysis
14.5 FMEA in the context of Risk Management
14.6 Design Failure Modes and Effects Analysis (DFMEA)
14.7 Process Failure Modes and Effects Analysis (PFMEA)
14.8 Use/Misuse Failure Modes and Effects Analysis (UMFMEA)
14.9 P-Diagram
14.10 Comparison of FTA, FMEA
Chapter 15. Software Risk Management
Abstract
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
Chapter 16. Integration of Risk Analysis
Abstract
16.1 Hierarchical Multi-Level FMEA
16.2 Integration of Supplier Input into Risk Management
Chapter 17. Risk Estimation
Abstract
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
Chapter 18. Risk Controls
Abstract
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 of Information for Safety
18.6 Sample Risk Controls
18.7 Risk Controls and Safety Requirements
18.8 Completeness of Risk Controls
Chapter 19. Verification of Risk Controls
Abstract
19.1 Verification of Implementation
19.2 Verification of Effectiveness
Chapter 20. On Testing
Abstract
20.1 Types of Testing
20.2 Risk-Based Sample Size Selection
20.3 Attribute Testing
20.4 Variable Testing
Chapter 21. Risk Evaluation
Abstract
21.1 Application of Risk Acceptance Criteria
21.2 Risk Evaluation for Qualitative Method
21.3 Risk Evaluation for Semi-Quantitative Method
21.4 Risk Evaluation for Quantitative Method
Chapter 22. Risk Assessment and Control Table
Abstract
22.1 RACT Workflow
22.2 Individual and Overall Residual Risks
22.3 Inherent Risks
Chapter 23. Benefit-Risk Analysis
Abstract
23.1 What is a Benefit?
23.2 Balancing Benefits against Risks
23.3 Benefit-Risk Analysis in Clinical Studies
Chapter 24. Risk Management Review
Abstract
Chapter 25. Production and Post-Production Activities
Abstract
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
25.5 Deliverables of Post-Market Risk Management
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
Chapter 26. Traceability
Abstract
Chapter 27. Lifetime of a Medical Device
Abstract
Chapter 28. Safety Versus Reliability
Abstract
Chapter 29. Risk Management for System of Systems
Abstract
29.1 Definition of System of Systems
29.2 Direct and Indirect Harms
29.3 Assessment of the Risks of an SoS
Chapter 30. Risk Management for Clinical Investigations
Abstract
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
Chapter 31. Risk Management for Legacy Devices
Abstract
Chapter 32. Risk Management for Combination Medical Devices
Abstract
Chapter 33. Basic Safety and Essential Performance
Abstract
33.1 How to Identify Basic Safety
33.2 How to Identify Essential Performance
Chapter 34. Relationship between ISO 14971 and other Standards
Abstract
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
Chapter 35. Risk Management Process Metrics
Abstract
35.1 Comparison with Historical Projects
35.2 Issue Detection History
35.3 Subjective Evaluation
Chapter 36. Risk Management and Product Development Process
Abstract
36.1 Identification of Essential Design Outputs
36.2 Life Cycle Relevance of Risk Management
Chapter 37. Risk Management for Suppliers
Abstract
37.1 Manufacturer Perspective
37.2 Supplier Perspective
Chapter 38. Axioms
Abstract
Chapter 39. Special Topics
Abstract
39.1 The Conundrum
39.2 Cassandras
39.3 Personal Liability
39.4 Creating a Safety Culture
39.5 Predicting the Future
Chapter 40. Critical Thinking and Risk Management
Abstract
Chapter 41. Advice and Wisdom
Abstract
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
C.9 Process Failure Modes and Effect Analysis
C.10 Use/Misuse Failure Modes and Effects Analysis
C.11 Software Failure Modes and Effects Analysis
C.12 Risk Assessment and Controls Table
C.13 Risk Management Report
Appendix D. Useful References
References
Index

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, USA

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Safety Risk Management for Medical Devices

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