Table Of ContentBiomedical Science / Biomedical Engineering R Preventing Medical
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A critical and often overlooked aspect of preventing medical device recalls is the
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ability to implement systems thinking. Although systems thinking won’t prevent
Device Recalls
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every mistake, it remains one of the most effective tools for evaluating hidden A
risks and discovering robust solutions for eliminating those risks.
Based on the author’s extensive experience in the medical device, aerospace,
and manufacturing engineering industries, Preventing Medical Device Recalls P
presents a detailed structure for systems thinking that can help to prevent
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costly device recalls. Based on Dr. W. Edwards Deming’s System of Profound e
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Knowledge, this structure can help medical device designers and manufacturers
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exceed their customers’ expectations for quality and safety.
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This book is among the first to demonstrate how to control safety risks—from i
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specifications all the way through to safely retiring products without harm to the
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environment. Supplying an accessible overview of medical device requirements
and the science of safety, it explains why risk analysis must start with product M
specification and continue throughout the product life cycle.
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Covering paradigms for proactive thinking and doing, the text details meth-
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ods that readers can implement during the specification writing, product design,
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and product development phases to prevent recalls. It also includes numerous
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examples from the author’s experience in the medical device, consumer, and
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aerospace industries.
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Even in healthcare, where compliance with standards is at its highest level, more
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patients die from medical mistakes each week than would be involved in a jumbo c
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jet crash. With coverage that includes risk assessment and risk management, this
book provides you with an understanding of how mishaps happen so you can
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account for unexpected events and design devices that are free of costly recalls.
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Preventing Medical
Device Recalls
Preventing Medical
Device Recalls
DEV RAHEJA
CRC Press
Taylor & Francis Group
6000 Broken Sound Parkway NW, Suite 300
Boca Raton, FL 33487-2742
© 2015 by Taylor & Francis Group, LLC
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Version Date: 20140611
International Standard Book Number-13: 978-1-4665-6823-5 (eBook - PDF)
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This book is dedicated to the managers and engineers who
do their best so nothing bad can happen to patients.
Contents
Preface ..........................................................................xv
Acknowledgment ....................................................... xvii
About the Author ........................................................ xix
1 Introduction to Medical Device Requirements ........1
Introduction .........................................................................1
The Challenges ....................................................................3
Sources of Errors .................................................................3
Understanding the Science of Safety ..................................7
Overview of FDA Quality System Regulation ............7
Overview of Risk Management Standard ISO 14971 ...9
Overview of FDA Device Approval Process .............10
Overview of Regulatory Requirements for
Clinical Trials ..............................................................11
Summary ............................................................................13
References ..........................................................................14
2 Preventing Recalls during Specification Writing ...17
Introduction ........................................................................17
Conduct Requirements Analysis to Identify Missing
Requirements......................................................................18
Specifications for Safety, Durability, and Reliability ..........22
Specification for User Interface and Usability ...................26
Specification for Maintainability ........................................26
Specification for Prognostics .............................................28
Specification for Safe Software ..........................................29
vii
viii ◾ Contents
Negative Requirements Analysis for Worst- Case
Scenarios ............................................................................29
Conducting PHA to Assess Risks ......................................30
Considerations for In Vitro Devices ...................................30
Summary ............................................................................31
References ..........................................................................31
3 Risk Assessment and Risk Management ...............33
Introduction ........................................................................33
Developing Risk Acceptance Criteria ................................34
Risk Analysis Using PHA ...................................................35
Assessing the Risk ..............................................................37
Mitigating Risks Using World- Class Practices ....................38
Risk Evaluation ...................................................................40
Managing Residual Risks ...................................................40
Summary ............................................................................41
Reference ............................................................................41
4 Preventing Recalls during Early Design ................43
Introduction ........................................................................43
Functional FMEA on Design Concept to Prevent
Failures ..............................................................................44
Conducting a Component- Level FMEA to Identify
Parameters Critical to Quality ............................................45
Conduct an FTA to Develop Robust Solutions for
Complex Problems .............................................................47
Strategy for Developing Solutions .....................................51
Summary ............................................................................52
References ..........................................................................52
5 Preventing Recalls during the Detail Design
Phase .....................................................................53
Introduction ........................................................................53
Designing for Durability ....................................................54
Designing for Reliability ....................................................56
Designing for Inherent Safety ............................................58
Designing for Inherent Quality .........................................60
