Biomaterials, Medical Devices, and Combination Products

NOTE EDITORE

Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for—or concerned with—developing and ensuring patient safety in the use and manufacture of medical devices. The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical safety of the materials used in producing medical devices as well as the devices themselves. Starting with material characterization and selection, considerations of concerns arising from packaging and contact with production machinery, and extensive coverage of combination products, the book also provides the latest approaches to isolating, quantitating, identifying and assessing the risk arising from chemical entities released from market-ready devices. Also incorporated are new case examples and citations with the means of access to Internet-based regulatory and scientific sites, reflecting the universal adoption of this technology into our world. The book takes into consideration the fact that device markets are global, the continual advancement of technology, and the increasing global harmonization of safety regulations. Each aspect of device safety evaluation is reviewed in terms of the International Organization for Standardization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health, Labour, and Welfare (MHLW) perspectives.

SOMMARIO

Safety Evaluation of Medical DevicesIntroductionBiocompatibilityFundamentals of Biocompatibility TestsScope of Devices and the Medical Device MarketHistory Nonspecific Regulatory ConsiderationsReferencesRegulatory Aspects and Strategy in Medical Device and Biomaterials Safety EvaluationRegulatory BasisToxicity Testing: Medical DevicesReferencesRoad Map to Test SelectionsKey ConceptsReferencesMaterials in Medical Device DesignIntroductionMetalsCeramics and GlassesPolymersTextilesBiologically Sourced MaterialsSurface-Modifying MaterialsTissue Engineering ScaffoldsNanomaterialsReferencesWhat to Test: Sampling and Sample PreparationSamplingRandomizationSample PreparationReference MaterialsConclusionReferencesCytotoxicity TestingIntroductionBackgroundCrystal Violet StainingSilicone MicrophysiometerMicrotox TestNeutral Red Uptake (NRU) AssayMTTAgar Diffusion TestDirect Contact TestElution TestColony-Forming Assay (CFA)Correlation With In Vivo ResultsConclusionReferencesHemocompatibility (ISO 10993-4)Noncontact DevicesExternal Communicating DevicesImplant DevicesHemolysis TestsThe Osmotic Fragility TestErythrocyte StabilityWhole Blood Clotting TimeThrombogenicityComplement ActivationProtein AdsorptionCoagulationPlateletsConclusionReferencesLocal Tissue ToleranceDermal IrritationOcular Irritation TestingOther Nonparenteral Route Irritation TestsParenteral Irritation/ToleranceParenteral RoutesIntracutaneous IrritationFactors Affecting Irritation Responses and Test OutcomeReferencesImmunotoxicology (ISO 10993-20)Overview of the Immune SystemImmunotoxic EffectsImmunosuppressionImmunostimulationEvaluation of the Immune SystemImmunopathologic AssessmentsHumoral ImmunityCell-Mediated ImmunityNonspecific ImmunityHost-Resistance AssaysHypersensitivityLocal Lymph Node Assay (LLNA)ApproachesProblems and Future DirectionsReferencesImplantation Biology and StudiesUsp Implantation TestISO 10993 Implantation TestPreparation of Specimens for ImplantationTest Method for Implantation in Subcutaneous TissueReferencesAcute Systemic Toxicity Testing and Device Safety EvaluationIntroductionAcute Systemic Toxicity CharacterizationReferencesGenotoxicityIntroductionDNA StructureCytogeneticsReferencesSubchronic and Chronic Toxicity and Reproductive and Developmental ToxicityIntroductionObjectivesRegulatory ConsiderationsStudy Design and ConductParameters to MeasureHistopathologyStudy Interpretation and ReportingReproductive and Developmental ToxicityIntroductionICH Study DesignsMethodological IssuesData InterpretationReferencesCarcinogenicityAnimal ModelDose SelectionInterpretation of ResultsReferencesDegradation Products and Impurities Processes in Medical DevicesIntroductionMetalsCeramics and GlassesDegradation ProcessesEffects of SterilizationInterpretation of Sterility Test ResultsHeavy MetalsAcknowledgmentReferencesSpecial Case DevicesIntroductionRespiratory and Inhalation DevicesOphthalmic DevicesCardiovascular Devices and ProsthesesTamponsDevices for DentistryReferencesCombination ProductsDevice/Drug Combination ProductsHistorical BackgroundReferencesClinical Studies for Medical DevicesDesign ConsiderationsEpidemiologyConclusionReferencesLeachables and Extractables from Medical DevicesIntroductionSample PreparationGeneral Principles of Leachables and Extractables under ISO 10993Analytical MethodsRisk Assessment of Extracted MoietiesIntroduction to (Q)SAR for Leachable and Extractable EvaluationRisk Assessment for Leachables and ExtractablesReferencesToxicokinetics in Biomaterial and Device Safety EvaluationIntroductionRegulationsPrinciplesLaboratory MethodsPhysiologically Based Pharmacokinetic (PBPK) ModelingBiologically Derived MaterialsReferencesSpecial StudiesAnti-Infective MaterialsSpecific Tests21-Day Eye Irritation Study in RabbitsSystemic Injection TestProduction of Toxic Shock Syndrome Toxin-1 (TSST-1)Inflammatory Responses to BiomaterialsReferencesCase Histories and Problem ResolutionPhthalates Leaching From Polymer DevicesBPA: Bisphenol ATalc on Gloves and CondomsLatex AllergySilicones in Devices (Historical)Intrauterine DevicesToxic Shock Syndrome (Historical)ConclusionReferencesAppendix A: Selected Regulatory and Toxicological AcronymsAppendix B: Contract Testing LaboratoriesAppendix C: Notable Regulatory Internet AddressesAppendix D: Non-U.S. Medical Device Regulators

AUTORE

Shayne Cox Gad, PhD, DABT, Gad Consulting Services, Raleigh, North Carolina, USA Samantha Gad-McDonald, B.S.ENGR, Gad Consulting Services, Raleigh, North Carolina, USA

ALTRE INFORMAZIONI

• Condizione: Nuovo
• ISBN: 9781482248371
• Dimensioni: 10 x 7 in Ø 2.82 lb
• Formato: Copertina rigida
• Illustration Notes: 70 b/w images, 156 tables and 5 lines/10 total equations
• Pagine Arabe: 584
• Pagine Romane: xxii