Safety risk management for medical devices / Bijan Elahi.

Format:

Book

Author/Creator:

Elahi, Bijan, author.

Language:

English

Subjects (All):

Medical instruments and apparatus industry--Risk management.

Medical instruments and apparatus industry.

Physical Description:

1 online resource (426 pages)

Edition:

1st ed.

Place of Publication:

London, United Kingdom : Academic Press, imprint of Elsevier, [2018]

Summary:

Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work.

Contents:

Front Cover

Safety Risk Management for Medical Devices

Copyright Page

Dedication

Contents

List of Figures

List of Tables

Biography

Preface

1 Introduction

2 Why Do Risk Management?

2.1 Legal and Regulatory Requirements

2.1.1 United States

2.1.2 European Union

2.1.3 MDD/AIMDD and transition to EU MDR

2.2 Business Reasons

2.2.1 Cost efficiency

2.2.2 Avoiding recalls and field corrective actions

2.2.3 Better communications

2.3 Moral and Ethical Reasons

3 The Basics

3.1 Vocabulary of Risk Management

3.1.1 Further elaborations

3.1.1.1 Reasonably foreseeable misuse

3.2 Hazard Theory

3.3 System Types

4 Understanding Risk

4.1 Risk Definitions

4.2 Types of Risk

4.3 Contributors to Risk

4.4 Risk Perception

4.5 Risk Computation

5 Risk Management Standards

5.1 ISO 14971 History and Origins

5.2 Harmonized Standards

6 Requirements of the Risk Management Process

6.1 Risk Management Process

6.1.1 Risk analysis

6.1.1.1 Hazard identification

6.1.1.2 Risk estimation

6.1.2 Risk evaluation

6.1.3 Risk controls

6.1.4 Risk control verification

6.1.5 Monitoring

7 Quality Management System

8 Usability Engineering and Risk Analysis

8.1 Key Terms

8.2 Distinctions

8.3 User-Device Interaction Model

8.4 Use Failures

8.5 Environmental Factors

8.6 Design Means to Control Usability Risks

8.7 Task Analysis

8.8 Usability and Risk

8.8.1 Data gathering

8.8.2 Risk reduction and compliance with IEC 62366 process

9 Biocompatibility and Risk Management

10 The BXM Method

10.1 System Decomposition

10.2 Integration

10.3 Quantitative Risk Estimation

11 Risk Management Process

11.1 Management Responsibilities

11.2 Risk Management File

11.3 Risk Management Plan

11.3.1 Criteria for risk acceptability.

11.3.2 Other considerations for risk reduction end-point

11.4 Hazard Identification

11.5 Clinical Hazards List

11.6 Harms Assessment List

11.6.1 How to create a Harms Assessment List

11.6.1.1 Method 1-Using published data

11.6.1.2 Method 2-Using expert opinion

12 Risk Analysis Techniques

12.1 Fault Tree Analysis

12.1.1 Introduction

12.1.2 Theory

12.1.2.1 Primary, secondary, and command Faults

12.1.2.2 Immediate, necessary, and sufficient

12.1.2.3 State of Component-State of System

12.1.2.4 Common Cause Failures

12.1.3 Symbols

12.1.4 Methodology

12.1.5 Ground rules

12.1.5.1 Write faults as faults

12.1.5.2 No gate-to-gate connections

12.1.5.3 Mark low-likelihood faults as Basic Events

12.1.5.4 Don't model passive components

12.1.5.5 Be judicious in modeling secondary faults

12.2 Mind Map Analysis

12.2.1 Introduction

12.2.2 Theory

12.2.3 Methodology

12.3 Preliminary Hazard Analysis

12.3.1 Introduction

12.3.2 Methodology

12.3.2.1 Safety characteristics

12.3.2.2 Identify System Hazards

12.4 Failure Modes and Effects Analysis

12.4.1 Facilitation of FMEAs

12.4.2 Hierarchical multilevel FMEA

12.4.3 Failure theory

12.4.4 Ground rules

12.4.5 On merits of RPN for criticality ranking

12.4.6 Benefits of FMEA

12.4.7 FMEA weaknesses

12.4.8 Ownership of FMEA

12.4.9 Making your way through the FMEA

12.5 FMEA in the Context of Risk Management

12.6 Design Failure Modes and Effects Analysis

12.6.1 DFMEA workflow

12.6.1.1 Set scope

12.6.1.2 Identify primary and secondary functions

12.6.1.3 Analyze

12.7 Process Failure Modes and Effects Analysis

12.7.1 PFMEA workflow

12.7.1.1 Set scope

12.7.1.2 Identify primary and secondary functions

12.7.1.3 Process Flow Diagram

12.7.1.4 Analyze.

12.8 Use/Misuse Failure Modes and Effects Analysis

12.8.1 Distinctions

12.8.2 Use Specification Versus Intended Use

12.8.3 UMFMEA Workflow

12.8.3.1 Set scope

12.8.3.2 Identify primary and secondary functions

12.8.3.3 Analyze

12.9 P-Diagram

12.9.1 Input Signals

12.9.2 System

12.9.3 Control Factors

12.9.4 Noise Factors

12.9.5 Ideal Function

12.9.6 Error States

12.9.7 Workflow

12.10 Comparison of FTA, FMEA

13 Safety Versus Reliability

14 Influence of Security on Safety

15 Software Risk Management

15.1 Software Risk Analysis

15.2 Software Failure Modes and Effects Analysis (SFMEA)

15.2.1 Software Failure Modes and Effects Analysis Workflow

15.3 Software Safety Classification

15.4 The BXM Method for Software Risk Analysis

15.4.1 Case 1-Legacy software

15.4.2 Case 2-New software

15.5 Risk Management File Additions

15.6 Risk Controls

15.7 Legacy Software

15.8 Software of Unknown Provenance

15.9 Software Maintenance and Risk Management

15.10 Software Reliability Versus Software Safety

15.11 Tips for developing safety-critical software

16 Integration of Risk Analysis

16.1 Hierarchical Multilevel Failure Modes and Effects Analysis

16.2 Integration of Supplier Input Into Risk Management

17 Risk Estimation

17.1 Qualitative Method

17.2 Semiquantitative Method

17.3 Quantitative Method

17.4 Pre-/Post-risk

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 Sample Risk Controls

18.6 Risk Controls and Safety Requirements

18.7 Completeness of Risk Controls

19 Risk Evaluation

19.1 Application of Risk Acceptance Criteria.

19.2 Risk Evaluation for Qualitative Method

19.3 Risk Evaluation for Semiquantitative Method

19.4 Risk Evaluation for Quantitative Method

20 Risk Assessment and Control Table

20.1 Risk Assessment and Control Table Workflow

20.1.1 Examine the Clinical Hazards List

20.1.2 Capture End-Effects with Safety Impact

20.1.3 Populate the Initial Cause and Sequence of Events columns

20.1.4 Populate Hazardous Situations column

20.1.5 Revisit the Preliminary Hazard Analysis

20.1.6 Populate the P1 column

20.1.7 Populate the Risk Controls columns

20.1.8 Populate the Harm column

20.1.9 Populate the P2 columns

20.1.10 Compute risks

20.1.11 Risk evaluation

20.2 Individual and Overall Residual Risks

21 On Testing

21.1 Types of Testing

21.2 Risk-Based Sample Size Selection

21.3 Attribute Testing

21.4 Variable Testing

22 Verification of Risk Controls

22.1 Verification of Implementation

22.2 Verification of Effectiveness

23 Benefit-Risk Analysis

23.1 Benefit-Risk Analysis in Clinical Evaluations

24 Production and Postproduction Monitoring

24.1 Postmarket Risk Management

24.2 Frequency of Risk Management File Review

24.3 Feedback to Preproduction Risk Management

24.4 Benefits of Postmarket Surveillance

25 Traceability

26 Risk Management for Clinical Investigations

26.1 Terminology

26.2 Clinical Studies

26.3 Mapping of Risk Management Terminologies

26.4 Risk Management Requirements

26.5 Risk Documentation Requirements

27 Risk Management for Legacy Devices

28 Basic Safety and Essential Performance

28.1 How to Identify Basic Safety

28.2 How to Identify Essential Performance

29 Relationship Between ISO 14971 and Other Standards

29.1 Interaction With IEC 60601-1

29.2 Interaction With ISO 10993-1

29.3 Interaction With IEC 62366.

29.4 Interaction With ISO 14155

30 Risk Management Process Metrics

30.1 Comparison With Historical Projects

30.2 Issue Detection History

30.3 Subjective Evaluation

31 Risk Management and Product Development Process

31.1 Identification of Essential Design Outputs

31.2 Lifecycle Relevance of Risk Management

32 Axioms

33 Special Topics

33.1 The Conundrum

33.2 Cassandras

33.3 Personal Liability

33.4 Risk Management for Combination Medical Devices

34 Critical Thinking and Risk Management

35 Advice and Wisdom

Appendix A: Glossary

Appendix B: Templates

B.1 Design Failure Modes and Effects Analysis Template

B.2 Software Failure Modes and Effects Analysis Template

B.3 Process Failure Modes and Effects Analysis Template

B.4 Use-Misuse Failure Modes and Effects Analysis Template

B.5 Risk Assessment and Control Table 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 Risk Assessment and Controls Table

C.12 Hazard Analysis Report

C.13 Risk Management Report

Appendix D: NBRG Consensus Paper

References

Index

Back Cover.

Notes:

Description based on print version record.

Description based on publisher supplied metadata and other sources.

ISBN:

0-12-813099-7

OCLC:

1043555552