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