Raheja | Preventing Medical Device Recalls | Buch | sack.de

Raheja Preventing Medical Device Recalls



1. Auflage 2014, 230 Seiten, Gebunden, Format (B × H): 152 mm x 234 mm, Gewicht: 499 g
ISBN: 978-1-4665-6822-8
Verlag: CRC PR INC


Raheja Preventing Medical Device Recalls

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.

Zielgruppe


Managers and engineers in design, QA, manufacturing, regulatory compliance, and marketing; students in biomedical engineering; technical libraries.


Autoren/Hrsg.


Weitere Infos & Material


Introduction to Medical Device RequirementsIntroductionThe ChallengesSources of ErrorsUnderstanding 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 TrialsSummaryReferencesPreventing Recalls during Specification WritingIntroductionConduct Requirements Analysis to Identify Missing RequirementsSpecifications for Safety, Durability, and ReliabilitySpecification for User Interface and UsabilitySpecification for MaintainabilitySpecification for PrognosticsSpecification for Safe SoftwareNegative Requirements Analysis for Worst-Case ScenariosConducting PHA to Assess RisksConsiderations for In Vitro DevicesSummaryReferencesRisk Assessment and Risk ManagementIntroductionDeveloping Risk Acceptance CriteriaRisk Analysis Using PHAAssessing the RiskMitigating Risks Using World-Class PracticesRisk EvaluationManaging Residual RisksSummaryReferencePreventing Recalls during Early DesignIntroductionFunctional FMEA on Design Concept to Prevent FailuresConducting a Component-Level FMEA to Identify Parameters Critical to QualityConduct an FTA to Develop Robust Solutions for Complex ProblemsStrategy for Developing SolutionsSummaryReferencesPreventing Recalls during the Detail Design PhaseIntroductionDesigning for DurabilityDesigning for ReliabilityDesigning for Inherent SafetyDesigning for Inherent QualityDesigning to Forgive User ErrorsDesigning for Hazard-Free MaintenanceDesigning for PackagingDurability TestingSummaryReferencesDesigning for Prognostics to Protect PatientsIntroductionPreventing False Positives and False NegativesDesigning for Alerts When the Device Is Not Performing AccuratelyDesigning to Alert When a Device Is Near the Low End of the Prognostic DistanceShutting Down the Device in a Safe State if the Failure Cannot Be AvoidedProgress in Prognostics Health MonitoringSummaryReferencesPreventing Recalls during Production ValidationIntroductionUnderstanding Key Design Features That Result in Defect-Free ProductionUnderstanding the Theory of Profound Knowledge for Superior QualityConducting HAZOP Analysis to Identify Latent Hazards in the Manufacturing ProcessUsing ISO 14971 HACCP Analysis to Identify Critical Steps in a ProcessAssuring Conformance to Key Design Features without 100% Inspection or TestingAuditing to Identify Unacceptable Variation before Defects Are ProducedTaking Corrective and Preventive Actions Using the FDA System Training Production Operators to Identify Incidents That May Result in Device DefectsProduction Validation TestingSummaryReferencesPreventing Software Design RecallsIntroductionSoftware Requirements AnalysisSoftware FMEASoftware Interoperability AnalysisTestability AnalysisSelecting Software Structure and ArchitecturePrecautions for Off-the-Shelf SoftwareDesigning to Minimize User Interface Risks Common User Interface (UI) Issues Common Reasons for Use ErrorsSummaryReferencesPreventing Supply Chain Quality Defects to Avoid RecallsIntroductionWriting Good Supplier SpecificationsThe Art of Identifying the Features Critical to QualityAssessing Variation in Supplier QualitySupply Chain Control by SuppliersAssuring Reliability in PerformanceSummaryReferencePreventing Recalls Using a Verification ProcessIntroductionIndependent Verification during Specification ApprovalIndependent Verification during Final Design ApprovalIndependent Verification during Pilot Production ApprovalIndependent Verification of Supplier Quality AssuranceVerifying Day-to-Day Control in ProductionSummaryReferencePreventing Recalls Using Design Validation ProcessIntroductionDesign Validation Testing for ReliabilityDesign Validation Testing for DurabilityDesign Validation for SafetyUsing Field Validation to Identify New RisksSummaryReferenceRecall Planning to Maximize Efficiency in the Event of a RecallIntroductionOverview of the PlanImmediate Recall CoordinationReview of the Discovered RisksReview of Data ManagementVerification of Activities for EffectivenessClosing the RecallSummaryReferencesRole of Management in Preventing RecallsIntroductionManagement PoliciesManagement Tasks for Preventing RecallsProduct Management ProceduresManagement ReviewsMonitoring Risk Management ProcessesUsing Good Paradigms for EfficiencySummaryReferencesInnovation Methods Useful in Preventing RecallsIntroductionStop Using Outdated PracticesUse HeuristicsUse the Profound Knowledge of the Quality and Safety GurusUse Classic Innovation MethodsSummaryReferencesProactive Role of Marketing in Preventing RecallsIntroductionDon’t Repeat Failures of Yesterday in Devices of TomorrowGather Intelligence on Customer Safety Needs during Lead GenerationGather Intelligence on Safety and Quality Issues on Device Search EnginesParticipate in Design Reviews to Be an Advocate for UsersReview New Device Specifications with Trusted CustomersProvide Intelligence in Risk Assessment to Ensure the Public Health Benefits Outweigh the RiskMarket Safety Features to Promote the Device and to Get Feedback from UsersSummaryReferencesAppendix A: Medical Device Safety from the Hospital’s Point of ViewProtecting 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 ReductionReferencesAppendix B: The FDA Quality System RegulationCode 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 SystemSubpart B—Quality System Requirements Sec. 820.20 Management Responsibility Sec. 820.22 Quality Audit Sec. 820.25 PersonnelSubpart C—Design Controls Sec. 820.30 Design ControlsSubpart D—Document Controls Sec. 820.40 Document ControlsSubpart E—Purchasing Controls Sec. 820.50 Purchasing ControlsSubpart F—Identification and Traceability Sec. 820.60 Identification Sec. 820.65 TraceabilitySubpart G—Production and Process Controls Sec. 820.70 Production and Process Controls Sec. 820.72 Inspection, Measuring, and Test Equipment Sec. 820.75 Process ValidationSubpart H—Acceptance Activities Sec. 820.80 Receiving, In-Process, and Finished Device Acceptance Sec. 820.86 Acceptance StatusSubpart I—Nonconforming Product Sec. 820.90 Nonconforming ProductSubpart J—Corrective and Preventive Action Sec. 820.100 Corrective and Preventive ActionSubpart K—Labeling and Packaging Control Sec. 820.120 Device Labeling Sec. 820.130 Device PackagingSubpart L—Handling, Storage, Distribution, and Installation Sec. 820.140 Handling Sec. 820.150 Storage Sec. 820.160 Distribution Sec. 820.170 InstallationSubpart 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 FilesSubpart N—Servicing Sec. 820.200 ServicingSubpart O—Statistical Techniques Sec. 820.250 Statistical TechniquesIndex


Raheja, Dev
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.


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