Preventing Medical Device Recalls: 1st Edition (Hardback) book cover

Preventing Medical Device Recalls

1st Edition

By Dev Raheja

CRC Press

230 pages | 37 B/W Illus.

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pub: 2014-07-25
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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 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.

Table of Contents

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


About the Author

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.

Subject Categories

BISAC Subject Codes/Headings:
BUSINESS & ECONOMICS / Industries / Service Industries
LAW / Medical Law & Legislation
MEDICAL / Administration
MEDICAL / Biotechnology