A critical and often overlooked aspect of preventing medical device recalls is the ability to implement systems thinking. Although systems thinking won’t 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 author’s 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 Deming’s 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 risks—from 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 author’s 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.
Introduction to Medical Device Requirements
Introduction
The Challenges
Sources of Errors
Understanding the Science of Safety
Overview of FDA Quality System Regulation
Overview of Risk Management Standard ISO 14971
Overview of FDA Device Approval Process
Overview of Regulatory Requirements for Clinical Trials
Summary
References
Preventing Recalls during Specification Writing
Introduction
Conduct Requirements Analysis to Identify Missing Requirements
Specifications for Safety, Durability, and Reliability
Specification for User Interface and Usability
Specification for Maintainability
Specification for Prognostics
Specification for Safe Software
Negative Requirements Analysis for Worst-Case Scenarios
Conducting PHA to Assess Risks
Considerations for In Vitro Devices
Summary
References
Risk Assessment and Risk Management
Introduction
Developing Risk Acceptance Criteria
Risk Analysis Using PHA
Assessing the Risk
Mitigating Risks Using World-Class Practices
Risk Evaluation
Managing Residual Risks
Summary
Reference
Preventing Recalls during Early Design
Introduction
Functional FMEA on Design Concept to Prevent Failures
Conducting a Component-Level FMEA to Identify Parameters Critical to Quality
Conduct an FTA to Develop Robust Solutions for Complex Problems
Strategy for Developing Solutions
Summary
References
Preventing Recalls during the Detail Design Phase
Introduction
Designing for Durability
Designing for Reliability
Designing for Inherent Safety
Designing for Inherent Quality
Designing to Forgive User Errors
Designing for Hazard-Free Maintenance
Designing for Packaging
Durability Testing
Summary
References
Designing for Prognostics to Protect Patients
Introduction
Preventing False Positives and False Negatives
Designing for Alerts When the Device Is Not Performing Accurately
Designing to Alert When a Device Is Near the Low End of the Prognostic Distance
Shutting Down the Device in a Safe State if the Failure Cannot Be Avoided
Progress in Prognostics Health Monitoring
Summary
References
Preventing Recalls during Production Validation
Introduction
Understanding Key Design Features That Result in Defect-Free Production
Understanding the Theory of Profound Knowledge for Superior Quality
Conducting HAZOP Analysis to Identify Latent Hazards in the Manufacturing Process
Using ISO 14971 HACCP Analysis to Identify Critical Steps in a Process
Assuring Conformance to Key Design Features without 100% Inspection or Testing
Auditing to Identify Unacceptable Variation before Defects Are Produced
Taking Corrective and Preventive Actions Using the FDA System Training Production Operators to Identify Incidents That May Result in Device Defects
Production Validation Testing
Summary
References
Preventing Software Design Recalls
Introduction
Software Requirements Analysis
Software FMEA
Software Interoperability Analysis
Testability Analysis
Selecting Software Structure and Architecture
Precautions for Off-the-Shelf Software
Designing to Minimize User Interface Risks
Common User Interface (UI) Issues
Common Reasons for Use Errors
Summary
References
Preventing Supply Chain Quality Defects to Avoid Recalls
Introduction
Writing Good Supplier Specifications
The Art of Identifying the Features Critical to Quality
Assessing Variation in Supplier Quality
Supply Chain Control by Suppliers
Assuring Reliability in Performance
Summary
Reference
Preventing Recalls Using a Verification Process
Introduction
Independent Verification during Specification Approval
Independent Verification during Final Design Approval
Independent Verification during Pilot Production Approval
Independent Verification of Supplier Quality Assurance
Verifying Day-to-Day Control in Production
Summary
Reference
Preventing Recalls Using Design Validation Process
Introduction
Design Validation Testing for Reliability
Design Validation Testing for Durability
Design Validation for Safety
Using Field Validation to Identify New Risks
Summary
Reference
Recall Planning to Maximize Efficiency in the Event of a Recall
Introduction
Overview of the Plan
Immediate Recall Coordination
Review of the Discovered Risks
Review of Data Management
Verification of Activities for Effectiveness
Closing the Recall
Summary
References
Role of Management in Preventing Recalls
Introduction
Management Policies
Management Tasks for Preventing Recalls
Product Management Procedures
Management Reviews
Monitoring Risk Management Processes
Using Good Paradigms for Efficiency
Summary
References
Innovation Methods Useful in Preventing Recalls
Introduction
Stop Using Outdated Practices
Use Heuristics
Use the Profound Knowledge of the Quality and Safety Gurus
Use Classic Innovation Methods
Summary
References
Proactive Role of Marketing in Preventing Recalls
Introduction
Don’t Repeat Failures of Yesterday in Devices of Tomorrow
Gather Intelligence on Customer Safety Needs during Lead Generation
Gather Intelligence on Safety and Quality Issues on Device Search Engines
Participate in Design Reviews to Be an Advocate for Users
Review New Device Specifications with Trusted Customers
Provide Intelligence in Risk Assessment to Ensure the Public Health Benefits Outweigh the Risk
Market Safety Features to Promote the Device and to Get Feedback from Users
Summary
References
Appendix A: Medical Device Safety from the Hospital’s Point of View
Protecting Patients from Hidden Dangers in Medical Devices
What Are the Dangers?
How Can Hospitals Protect Patients from These Dangers?
Use a Team Approach to Risk Reduction
References
Appendix B: The FDA Quality System Regulation
Code of Federal Regulations Title 21 (Food and Drugs), Part 820
Subpart A—General Provisions
Sec. 820.1 Scope
Sec. 820.3 Definitions
Sec. 820.5 Quality System
Subpart B—Quality System Requirements
Sec. 820.20 Management Responsibility
Sec. 820.22 Quality Audit
Sec. 820.25 Personnel
Subpart C—Design Controls
Sec. 820.30 Design Controls
Subpart D—Document Controls
Sec. 820.40 Document Controls
Subpart E—Purchasing Controls
Sec. 820.50 Purchasing Controls
Subpart F—Identification and Traceability
Sec. 820.60 Identification
Sec. 820.65 Traceability
Subpart G—Production and Process Controls
Sec. 820.70 Production and Process Controls
Sec. 820.72 Inspection, Measuring, and Test Equipment
Sec. 820.75 Process Validation
Subpart H—Acceptance Activities
Sec. 820.80 Receiving, In-Process, and Finished Device Acceptance
Sec. 820.86 Acceptance Status
Subpart I—Nonconforming Product
Sec. 820.90 Nonconforming Product
Subpart J—Corrective and Preventive Action
Sec. 820.100 Corrective and Preventive Action
Subpart K—Labeling and Packaging Control
Sec. 820.120 Device Labeling
Sec. 820.130 Device Packaging
Subpart L—Handling, Storage, Distribution, and Installation
Sec. 820.140 Handling
Sec. 820.150 Storage
Sec. 820.160 Distribution
Sec. 820.170 Installation
Subpart M—Records
Sec. 820.180 General Requirements
Sec. 820.181 Device Master Record
Sec. 820.184 Device History Record
Sec. 820.186 Quality System Record
Sec. 820.198 Complaint Files
Subpart N—Servicing
Sec. 820.200 Servicing
Subpart O—Statistical Techniques
Sec. 820.250 Statistical Techniques
Index
Biography
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 master’s 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.
