Hafez selim (8 Ergebnisse)

Taschenbuch. Zustand: Neu. Neuware - Safety is never one person's job.A medical device is designed by engineers, cleared by regulators, chosen by physicians, and used - minute by minute - by nurses. Each holds a piece of its safety that no one else can hold for them. Yet almost every book on the subject speaks to only one of these readers. The Long Life of a Safe Device is written for all of them at once.This is a practical, plain-spoken guide to keeping medical devices - and the patients who depend on them - safe across a device's entire lifecycle, from the first design decision to final disposal. It turns the core disciplines of device safety into a single, readable narrative, and wherever a point lands differently for a nurse, a physician, or an engineer, a short labeled aside says so.>What a medical device is, how it's classified, and the global regulatory landscape (FDA, EU MDR/IVDR, and beyond)Risk management the way ISO 14971 intends it - from hazard identification and estimation to risk controls and residual riskSafety built in during development: quality systems (ISO 13485), biocompatibility (ISO 10993), materials of animal origin, and clinical evaluationSafety defended in the market: maintenance, user training, vigilance and incident response, causality assessment, post-market surveillance, PMCF, and PSURs>Who it's for: Nurses and clinicians at the point of care. Physicians selecting and overseeing devices. Design, quality, and regulatory engineers who build the evidence. Safety and pharmacovigilance professionals who monitor devices in use. Students and newcomers who want the whole picture in one place.Clear enough to read cover to cover and organized to return to as a reference, The Long Life of a Safe Device gives every member of the team not only their own responsibility - but the visibility to trust their colleagues are holding theirs.Written by Hafez Selim, MD, PhD, a physician and scientist with deep experience in medical device and drug safety across the product lifecycle, from premarket development through post-market surveillance.…

Taschenbuch. Zustand: Neu. Neuware.

Taschenbuch. Zustand: Neu. Neuware.

Taschenbuch. Zustand: Neu. Neuware - The first book on signal management written for medical devices.Device companies receive complaints, code them, decide what is reportable, and file on time. What most of them lack is an owner for the question that connects all of that work: what does this pattern mean, and what must change because of it Pharmacovigilance answered that question years ago with a named discipline. Device regulation never did. EU MDR Article 88 asks for trend reports, ISO 14971 asks for post-production information to flow into the risk file, and ISO 13485 asks for complaints to be investigated, but none of them tells a vigilance specialist how to recognize that three fractures at a new location matter more than ninety cosmetic complaints, or how to defend a decision not to act when an auditor reads the record two years later.This book fills that gap. In 28 chapters it follows a signal from the first complaint to the closed record: detection across complaints, returned devices, registries, clinical follow-up and device telemetry; control charts, CUSUM and Article 88 thresholds; disproportionality and registry outlier methods; time-to-failure and survival analysis; validation, prioritization and the written assessment question; case series and returned-device investigation; root cause across design, manufacturing, use and patient; integrated assessment and causality; the ISO 14971 risk file update; the action ladder from monitoring to field safety corrective action; benefit-risk; field safety notices; review boards, documentation, audits and metrics; and the place of AI and real-world data.Eight fictional devices carry the argument with fixed numbers that match across every chapter: a hip implant, an antibiotic-loaded bone void filler, an insulin pump, an infusion pump, a defibrillator lead, an AI triage tool, a surgical stapler and a central venous catheter. Every chapter ends with a one-page Bottom Line, five knowledge-check questions and an applied exercise, with full answers. A companion website provides 24 editable toolkit files, six calculators and an interactive Case Lab that runs all eight cases through the ten-step process.Written for manufacturer vigilance and post-market surveillance specialists, complaint-handling leads, safety physicians, risk management engineers, quality and CAPA owners, and regulatory affairs professionals. Companion to Signal Management in Pharmacovigilance by the same author.…

Taschenbuch. Zustand: Neu. Neuware - A medical device passes through many hands - designed by engineers, cleared by regulators, chosen by physicians, and used minute by minute by nurses - and its safety lives in the seams between those roles. Applied Medical Device Safety: A Comprehensive Guide is the rare book written for all of them at once, tracing a device's full life from design to disposal while teaching the working discipline that keeps patients safe at every stage.Part narrative and part training manual, the book builds from first principles: what a device is and how it is classified, the regulatory landscape it lives within, and the ISO 14971 risk-management process carried out end to end. From there it moves through the safety work of development - quality systems (ISO 13485), biocompatibility (ISO 10993), materials, and clinical evaluation - and into the market, where safety becomes a matter of maintenance, training, vigilance, and the structured investigations that follow an adverse event.At its operational heart is the Safety Specialist's Task Manual: step-by-step procedures for the tasks the role actually performs - writing and processing a case safety report, assessing causality, preparing aggregate reports and the PSUR, running a risk assessment, and constructing a defensible benefit-risk analysis - each with a working template, a fully solved example, and a self-check. Real device failures are then examined directly, and ready-to-adapt templates and interactive tools turn the methods into working aids.Whether you are a nurse or physician moving into device safety, an engineer who must defend a design in the regulatory file, or a professional who wants to become a medical device safety specialist, this is a single volume that explains the field and shows you how to do its work.…

Taschenbuch. Zustand: Neu. Neuware - Which bone graft is best That is usually the wrong question.The more useful questions are: Which biological and mechanical properties does this specific defect require Does the proposed graft provide those properties How strong is the evidence-and what safety burden accompanies its use Safety and Effectiveness Profiles of Bone Grafts and Bone Graft Substitutes provides a practical, evidence-based framework for answering these questions. Written by physician-scientist and medical-device safety expert Dr. Hafez Selim, this comprehensive reference integrates bone biology, biomaterials science, clinical evidence, product safety, regulatory pathways, and real-world implementation.Inside, readers will find: - Detailed profiles of autografts, allografts, demineralized bone matrices, cellular bone matrices, xenografts, calcium-phosphate ceramics, cements, bioactive glass, synthetic composites, BMPs, PDGF products, P-15 peptides, marrow concentrates, and platelet-based therapies- Application-specific guidance for spine surgery, fractures, nonunion, segmental defects, foot and ankle procedures, dental and maxillofacial grafting, oncologic reconstruction, infection, and special populations- Structured methods for evaluating clinical effectiveness, adverse effects, donor-transmission risks, traceability, recalls, and post-market safety signals- Clear explanations of United States and European regulatory pathways-and why regulatory authorization should never be mistaken for clinical proof- Worked clinical vignettes, selection algorithms, evidence-appraisal checklists, comparison tables, a master material matrix, and a consolidated safety signal register- Practical guidance for patient optimization, shared decision-making, procurement, operating-room handling, documentation, outcome reporting, and institutional product review- An interactive companion tool that helps translate patient and defect characteristics into a required graft-property profileRather than treating every product within a material class as interchangeable, this book emphasizes exact formulation, processing, dose, carrier, indication, comparator, and clinical endpoint. It also identifies where evidence is strong, where extrapolation is inappropriate, and where uncertainty must be clearly communicated.With a foreword by Dr. Mohamed Attawia, this book is designed for orthopaedic, spine, foot-and-ankle, dental, and maxillofacial clinicians; trainees; biomaterials scientists; product-development engineers; medical safety and regulatory professionals; researchers; and hospital value-analysis teams.A rigorous and practical guide for anyone responsible for selecting, evaluating, developing, purchasing, monitoring, or regulating bone graft materials.Evidence reviewed through August 2, 2026.…

Taschenbuch. Zustand: Neu. Neuware - Applied Drug Safety and Adverse Drug Reactions: A Comprehensive ReferenceBy Hafez Selim, MD, PhD Foreword by Tim Sullivan, MDThe definitive reference for identifying, assessing, and managing adverse drug reactions - written by a practicing safety physician with 15+ years of global pharmacovigilance experience.Every medication carries the potential for harm. The challenge is not knowing that adverse drug reactions exist - it is recognizing them in real time, in real patients, amid competing diagnoses and incomplete information. This book gives you the framework to do exactly that.Applied Drug Safety and Adverse Drug Reactions is a comprehensive, organ-system-based reference covering the full spectrum of drug-induced injuries across 17 chapters. Each chapter follows a consistent clinical framework: mechanisms of injury, time-to-onset and risk window tables, differential diagnosis, causality assessment (Naranjo, WHO-UMC, RUCAM), clinical management, take-home messages, and peer-reviewed references.What makes this book different: Most pharmacology texts list adverse reactions. This book teaches you how to think about them. It emphasizes temporal patterns, dechallenge and rechallenge logic, and the structured reasoning that separates competent drug safety practice from guesswork.Chapters cover: Anaphylaxis, DILI, AKI, Blood Disorders, SJS/TEN and Skin Reactions, Drug-Induced Psychosis, Cardiac Disorders (QT Prolongation, Cardiomyopathy, Ischemia), Pulmonary Toxicity, Neurological Disorders, GI Reactions, Blood Pressure, Glucose Disturbances, Muscle Injury, Chemotherapy ADRs, Drug-Drug Interactions, ADR Reporting, and Risk Management. The Appendix provides detailed scoring guides for all three major causality assessment tools.Who this book is for: Safety physicians, pharmacovigilance scientists, pharmacists, clinical researchers, medical affairs professionals, regulatory professionals, and students building drug safety expertise.Online Learning Companion: Paired with the Applied Drug Safety Online Learning Platform at MedTech Talents Institute, featuring chapter quizzes, clinical simulations, and the Applied Drug Safety Diploma certification.…

Taschenbuch. Zustand: Neu. Neuware.