1st Edition

Preventing Medical Device Recalls

By Dev Raheja Copyright 2015
    230 Pages 37 B/W Illustrations
    by CRC Press

    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
    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

    Preventing Recalls during Specification Writing
    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

    Risk Assessment and Risk Management
    Developing Risk Acceptance Criteria
    Risk Analysis Using PHA
    Assessing the Risk
    Mitigating Risks Using World-Class Practices
    Risk Evaluation
    Managing Residual Risks

    Preventing Recalls during Early Design
    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

    Preventing Recalls during the Detail Design Phase
    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

    Designing for Prognostics to Protect Patients
    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

    Preventing Recalls during Production Validation
    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

    Preventing Software Design Recalls
    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

    Preventing Supply Chain Quality Defects to Avoid Recalls
    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

    Preventing Recalls Using a Verification Process
    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

    Preventing Recalls Using Design Validation Process
    Design Validation Testing for Reliability
    Design Validation Testing for Durability
    Design Validation for Safety
    Using Field Validation to Identify New Risks

    Recall Planning to Maximize Efficiency in the Event of a Recall
    Overview of the Plan
    Immediate Recall Coordination
    Review of the Discovered Risks
    Review of Data Management
    Verification of Activities for Effectiveness
    Closing the Recall

    Role of Management in Preventing Recalls
    Management Policies
    Management Tasks for Preventing Recalls
    Product Management Procedures
    Management Reviews
    Monitoring Risk Management Processes
    Using Good Paradigms for Efficiency

    Innovation Methods Useful in Preventing Recalls
    Stop Using Outdated Practices
    Use Heuristics
    Use the Profound Knowledge of the Quality and Safety Gurus
    Use Classic Innovation Methods

    Proactive Role of Marketing in Preventing Recalls
    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

    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

    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


    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.