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E-raamat: Preventing Medical Device Recalls

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  • Formaat: EPUB+DRM
  • Ilmumisaeg: 25-Jul-2014
  • Kirjastus: CRC Press Inc
  • Keel: eng
  • ISBN-13: 9781040181676
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Preventing Medical Device RecallsSuurem pilt
  • Formaat: EPUB+DRM
  • Ilmumisaeg: 25-Jul-2014
  • Kirjastus: CRC Press Inc
  • Keel: eng
  • ISBN-13: 9781040181676
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A critical and often overlooked aspect of preventing medical device recalls is the ability to implement systems thinking. Although systems thinking wont prevent every mistake, it remains one of the most effective tools for evaluating hidden risks and discovering robust solutions for eliminating those risks.

Based on the authors extensive experience in the medical device, aerospace, and manufacturing engineering industries, Preventing Medical Device Recalls presents a detailed structure for systems thinking that can help to prevent costly device recalls. Based on Dr. W. Edwards Demings System of Profound Knowledge, this structure can help medical device designers and manufacturers exceed their customers expectations for quality and safety.

This book is among the first to demonstrate how to control safety risksfrom specifications all the way through to safely retiring products without harm to the environment. Supplying an accessible overview of medical device requirements and the science of safety, it explains why risk analysis must start with product specification and continue throughout the product life cycle.

Covering paradigms for proactive thinking and doing, the text details methods that readers can implement during the specification writing, product design, and product development phases to prevent recalls. It also includes numerous examples from the authors experience in the medical device, consumer, and aerospace industries.

Even in healthcare, where compliance with standards is at its highest level, more patients die from medical mistakes each week than would be involved in a jumbo 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 account for unexpected events and design devices that are free of costly recalls.
Preface xv
Acknowledgment xvii
About the Author xix
1 Introduction to Medical Device Requirements 1(16)
Introduction
1(2)
The Challenges
3(1)
Sources of Errors
3(4)
Understanding the Science of Safety
7(6)
Overview of FDA Quality System Regulation
7(2)
Overview of Risk Management Standard ISO 14971
9(1)
Overview of FDA Device Approval Process
10(1)
Overview of Regulatory Requirements for Clinical Trials
11(2)
Summary
13(1)
References
14(3)
2 Preventing Recalls during Specification Writing 17(16)
Introduction
17(1)
Conduct Requirements Analysis to Identify Missing Requirements
18(4)
Specifications for Safety, Durability, and Reliability
22(4)
Specification for User Interface and Usability
26(1)
Specification for Maintainability
26(2)
Specification for Prognostics
28(1)
Specification for Safe Software
29(1)
Negative Requirements Analysis for Worst-Case Scenarios
29(1)
Conducting PHA to Assess Risks
30(1)
Considerations for In Vitro Devices
30(1)
Summary
31(1)
References
31(2)
3 Risk Assessment and Risk Management 33(10)
Introduction
33(1)
Developing Risk Acceptance Criteria
34(1)
Risk Analysis Using PHA
35(2)
Assessing the Risk
37(1)
Mitigating Risks Using World-Class Practices
38(2)
Risk Evaluation
40(1)
Managing Residual Risks
40(1)
Summary
41(1)
Reference
41(2)
4 Preventing Recalls during Early Design 43(10)
Introduction
43(1)
Functional FMEA on Design Concept to Prevent Failures
44(1)
Conducting a Component-Level FMEA to Identify Parameters Critical to Quality
45(2)
Conduct an FTA to Develop Robust Solutions for Complex Problems
47(4)
Strategy for Developing Solutions
51(1)
Summary
52(1)
References
52(1)
5 Preventing Recalls during the Detail Design Phase 53(16)
Introduction
53(1)
Designing for Durability
54(2)
Designing for Reliability
56(2)
Designing for Inherent Safety
58(2)
Designing for Inherent Quality
60(1)
Designing to Forgive User Errors
60(1)
Designing for Hazard-Free Maintenance
61(1)
Designing for Packaging
62(1)
Durability Testing
63(3)
Summary
66(1)
References
66(3)
6 Designing for Prognostics to Protect Patients 69(8)
Introduction
69(1)
Preventing False Positives and False Negatives
70(2)
Designing for Alerts When the Device Is Not Performing Accurately
72(1)
Designing to Alert When a Device Is Near the Low End of the Prognostic Distance
73(1)
Shutting Down the Device in a Safe State if the Failure Cannot Be Avoided
73(1)
Progress in Prognostics Health Monitoring
74(1)
Summary
75(1)
References
76(1)
7 Preventing Recalls during Production Validation 77(12)
Introduction
77(1)
Understanding Key Design Features That Result in Defect-Free Production
78(1)
Understanding the Theory of Profound Knowledge for Superior Quality
79(2)
Conducting HAZOP Analysis to Identify Latent Hazards in the Manufacturing Process
81(1)
Using ISO 14971 HACCP Analysis to Identify Critical Steps in a Process
81(1)
Assuring Conformance to Key Design Features without 100% Inspection or Testing
82(1)
Auditing to Identify Unacceptable Variation before Defects Are Produced
83(1)
Taking Corrective and Preventive Actions Using the FDA System
84(2)
Training Production Operators to Identify Incidents That May Result in Device Defects
86(1)
Production Validation Testing
86(2)
Summary
88(1)
References
88(1)
8 Preventing Software Design Recalls 89(14)
Introduction
89(1)
Software Requirements Analysis
90(3)
Software FMEA
93(1)
Software Interoperability Analysis
94(1)
Testability Analysis
94(2)
Selecting Software Structure and Architecture
96(1)
Precautions for Off-the-Shelf Software
97(2)
Designing to Minimize User Interface Risks
99(1)
Common User Interface (UI) Issues
100(1)
Common Reasons for Use Errors
100(1)
Summary
100(1)
References
101(2)
9 Preventing Supply Chain Quality Defects to Avoid Recalls 103(6)
Introduction
103(1)
Writing Good Supplier Specifications
104(1)
The Art of Identifying the Features Critical to Quality
105(1)
Assessing Variation in Supplier Quality
106(1)
Supply Chain Control by Suppliers
106(1)
Assuring Reliability in Performance
107(1)
Summary
107(1)
Reference
107(2)
10 Preventing Recalls Using a Verification Process 109(8)
Introduction
109(1)
Independent Verification during Specification Approval
110(1)
Independent Verification during Final Design Approval
111(1)
Independent Verification during Pilot Production Approval
112(1)
Independent Verification of Supplier Quality Assurance
113(1)
Verifying Day-to-Day Control in Production
114(2)
Summary
116(1)
Reference
116(1)
11 Preventing Recalls Using Design Validation Process 117(8)
Introduction
117(1)
Design Validation Testing for Reliability
118(2)
Design Validation Testing for Durability
120(1)
Design Validation for Safety
120(2)
Using Field Validation to Identify New Risks
122(1)
Summary
123(1)
Reference
123(2)
12 Recall Planning to Maximize Efficiency in the Event of a Recall 125(10)
Introduction
125(1)
Overview of the Plan
126(1)
Immediate Recall Coordination
127(1)
Review of the Discovered Risks
128(2)
Review of Data Management
130(2)
Verification of Activities for Effectiveness
132(1)
Closing the Recall
132(1)
Summary
133(1)
References
134(1)
13 Role of Management in Preventing Recalls 135(12)
Introduction
135(1)
Management Policies
136(1)
Management Tasks for Preventing Recalls
137(2)
Product Management Procedures
139(1)
Management Reviews
140(1)
Monitoring Risk Management Processes
141(2)
Using Good Paradigms for Efficiency
143(2)
Summary
145(1)
References
145(2)
14 Innovation Methods Useful in Preventing Recalls 147(12)
Introduction
147(1)
Stop Using Outdated Practices
148(3)
Use Heuristics
151(2)
Use the Profound Knowledge of the Quality and Safety Gurus
153(2)
Use Classic Innovation Methods
155(2)
Summary
157(1)
References
157(2)
15 Proactive Role of Marketing in Preventing Recalls 159(8)
Introduction
159(1)
Don't Repeat Failures of Yesterday in Devices of Tomorrow
160(1)
Gather Intelligence on Customer Safety Needs during Lead Generation
161(1)
Gather Intelligence on Safety and Quality Issues on Device Search Engines
161(1)
Participate in Design Reviews to Be an Advocate for Users
162(3)
Review New Device Specifications with Trusted Customers
165(1)
Provide Intelligence in Risk Assessment to Ensure the Public Health Benefits Outweigh the Risk
165(1)
Market Safety Features to Promote the Device and to Get Feedback from Users
166(1)
Summary
166(1)
References
166(1)
Appendix A: Medical Device Safety from the Hospital's Point of View 167(6)
Protecting Patients from Hidden Dangers in Medical Devices
167(4)
What Are the Dangers?
168(2)
How Can Hospitals Protect Patients from These Dangers?
170(1)
Use a Team Approach to Risk Reduction
171(1)
References
171(2)
Appendix B: The FDA Quality System Regulation 173(32)
Code of Federal Regulations Title 21 (Food and Drugs), Part 820
173(1)
Subpart A-General Provisions
173(6)
Sec. 820.1 Scope.
173(3)
Sec. 820.3 Definitions.
176(3)
Sec. 820.5 Quality System
179(1)
Subpart B-Quality System Requirements
179(3)
Sec. 820.20 Management Responsibility
179(2)
Sec. 820.22 Quality Audit.
181(1)
Sec. 820.25 Personnel.
181(1)
Subpart C-Design Controls
182(3)
Sec. 820.30 Design Controls.
182(3)
Subpart D-Document Controls
185(1)
Sec. 820.40 Document Controls.
185(1)
Subpart E-Purchasing Controls
185(1)
Sec. 820.50 Purchasing Controls
185(1)
Subpart F-Identification and Traceability
186(1)
Sec. 820.60 Identification
186(1)
Sec. 820.65 Traceability.
186(1)
Subpart G-Production and Process Controls
187(4)
Sec. 820.70 Production and Process Controls
187(2)
Sec. 820.72 Inspection, Measuring, and Test Equipment.
189(1)
Sec. 820.75 Process Validation
190(1)
Subpart H-Acceptance Activities
191(2)
Sec. 820.80 Receiving, In-Process, and Finished Device Acceptance.
191(1)
Sec. 820.86 Acceptance Status
192(1)
Subpart I-Nonconforming Product
193(1)
Sec. 820.90 Nonconforming Product
193(1)
Subpart J-Corrective and Preventive Action
194(1)
Sec. 820.100 Corrective and Preventive Action.
194(1)
Subpart K-Labeling and Packaging Control
195(1)
Sec. 820.120 Device Labeling.
195(1)
Sec. 820.130 Device Packaging.
195(1)
Subpart L-Handling, Storage, Distribution, and Installation
196(1)
Sec. 820.140 Handling
196(1)
Sec. 820.150 Storage.
196(1)
Sec. 820.160 Distribution.
196(1)
Sec. 820.170 Installation
197(1)
Subpart M-Records
197(5)
Sec. 820.180 General Requirements.
197(1)
Sec. 820.181 Device Master Record.
198(1)
Sec. 820.184 Device History Record
199(1)
Sec. 820.186 Quality System Record.
199(1)
Sec. 820.198 Complaint Files.
200(2)
Subpart N-Servicing
202(1)
Sec. 820.200 Servicing.
202(1)
Subpart O-Statistical Techniques
202(3)
Sec. 820.250 Statistical Techniques
202(3)
Index 205
Dev Raheja, MS, CSP, has been an international risk management and quality assurance consultant in the healthcare, medical device, and aerospace industries for more than 25 years. He applies evidence-based safety techniques from a variety of industries to healthcare.

He is a trainer, and author of the books Safer Hospital Care, Assurance Technologies Principles and Practices, and Design for Reliability. He shows clients how to create elegant solutions using creativity and innovation. Being a true international consultant, he has conducted training in several countries including Sweden, Australia, Japan, Germany, the United Kingdom, Singapore, Taiwan, South Africa, Finland, and Brazil. He helped a major company in the Midwestern United States avoid going out of business and become a world leader by eliminating safety mishaps.

Prior to becoming a consultant in 1982, he worked at GE Healthcare as supervisor of quality assurance and manager of manufacturing, and at Booz-Allen & Hamilton as a risk management consultant for the nuclear and mass transportation industry.

Raheja served as adjunct professor at the University of Maryland for five years in its PhD program in reliability engineering, and is currently an adjunct professor at Florida Tech for its BBA degree in healthcare management. He is associate editor for healthcare safety for the Journal of System Safety, and teaches webinars on medical device safety and reliability.

He has received several industry awards including the Scientific Achievement Award and Educator-of-the-Year Award from the System Safety Society and the Austin Bonis Reliability Education Award from the American Society for Quality.

He served as part of the first group of examiners for the Malcolm Baldrige National Quality Award, and served for 15 years on the board of directors of the Annual Reliability and Maintainability Conference sponsored by ten engineering societies. Currently he is a member of the Institute of Electrical and Electronics Engineers (IEEE), Association for the Advancement of Medical Instrumentation (AAMI), the American Society of Patient Safety Professionals, and the American College of Healthcare Executives.

Raheja majored in human factors engineering as a part of his masters degree in industrial engineering, is a Certified Safety Professional through the Board of Certified Safety Professionals, and serves as the chairman of the Design for Reliability Committee of the IEEE.
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