LEADER 05422nam 2200637 a 450 001 9910877722003321 005 20200520144314.0 010 $a1-280-95629-1 010 $a9786610956296 010 $a0-470-06087-5 010 $a0-470-06086-7 035 $a(CKB)1000000000357357 035 $a(EBL)291271 035 $a(OCoLC)191824601 035 $a(SSID)ssj0000200461 035 $a(PQKBManifestationID)11190094 035 $a(PQKBTitleCode)TC0000200461 035 $a(PQKBWorkID)10220538 035 $a(PQKB)10902202 035 $a(MiAaPQ)EBC291271 035 $a(PPN)230749070 035 $a(EXLCZ)991000000000357357 100 $a20061117d2007 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $2rdacontent 182 $2rdamedia 183 $2rdacarrier 200 00$aMedical device epidemiology and surveillance /$feditors, S. Lori Brown, Roselie A. Bright, and Dale R. Tavris 210 $aChichester, West Sussex, England ;$aHoboken, NJ $cJohn Wiley & Sons$dc2007 215 $a1 online resource (529 p.) 300 $aDescription based upon print version of record. 311 $a0-470-01595-0 320 $aIncludes bibliographical references and index. 327 $aMedical Device Epidemiology and Surveillance; Contents; Foreword; Preface; Contributors; Acknowledgments; 1 Introduction; 2 Medical device regulation in the USA; Introduction; Premarket review; Marketing applications; Postmarket oversight; Conclusion; 3 Medical device epidemiology; Introduction; Features of medical devices that are relevant to epidemiology study design; Study designs for medical device epidemiology; Summary and recommendations; 4 Surveillance of adverse medical device events; Introduction; Rationale for surveillance; Surveillance based on adverse event reports 327 $aSurveillance based on registriesActive surveillance; Necessary conditions for effective surveillance; Ideal AMDE surveillance program; Summary; 5 The Medical Product Surveillance Network (MedSun); Historical motivation; Initial considerations for the design of DeviceNet; MedSun basic design; Current status; Is MedSun successful in promoting the safe use of medical devices?; Epidemiologic considerations; Summary; 6 The National Electronic Injury Surveillance System (NEISS) and medical devices; Description and history of NEISS; Potential uses and limitations of NEISS 327 $aUtilization of NEISS to produce national medical device-associated adverse event estimatesPotential for long-term utilization of NEISS for medical device surveillance; 7 Medical device nomenclature; Technical elements; Current terminologies; Applications of nomenclature; Future developments; 8 Data sources for medical device epidemiology studies and data mining; Introduction; Data sources; Surveillance databases; Registries; Automated large administrative databases; National surveys; Data mining; Future use databases for medical device epidemiology 327 $a9 Ethical requirements and guidelines for epidemiological studiesof medical devicesIntroduction; Bioethics foundations; US government human subjects protection regulations; HHS human subjects protection regulatory requirements; FDA human subjects protection regulations; Other professional ethical guidelines; Ethical requirements for medical devices epidemiologic studies; Future ethical requirements for epidemiologic studies; 10 An industry perspective: medical device epidemiology and surveillance; Introduction 327 $aThe product's life cycle: premarket (preclinical and clinical) and postmarket (PM) studiesPostmarket studies; Summary; 11 Perspective from an academic on postmarket surveillance; Introduction; Adverse event reporting; Postmarket condition of approval studies and Section 522 studies; Industry use of information from adverse event reports; Academic opportunities; Summary; 12 Perspective from a pharmacoepidemiologist; Introduction; Review of literature; Contrasts with pharmacopeidemiology; Conclusions; 13 Medical device regulation and surveillance: perspective from the EU; Introduction 327 $aMedical devices: the European directives and definitions 330 $aMedical devices are crucial in medical care today and device technology advances at a dizzying pace. Medical Device Epidemiology and Surveillance is the first book to provide an overview of medical device epidemiology and surveillance as well as perspectives from regulatory agencies, the medical device industry, the health insurance industry and academia. The book is edited by experts from the US Food and Drug Administration with contributions from experienced specialists working in this field in the US and around the world. It features chapters describing broad themes in medical 606 $aMedical instruments and apparatus$xStandards$zUnited States 606 $aMedical instruments and apparatus$xSafety measures$zUnited States 615 0$aMedical instruments and apparatus$xStandards 615 0$aMedical instruments and apparatus$xSafety measures 676 $a610.28 701 $aBrown$b S. Lori$01761828 701 $aBright$b Roselie A$01761829 701 $aTavris$b Dale R$01761830 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910877722003321 996 $aMedical device epidemiology and surveillance$94201486 997 $aUNINA