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Medical device epidemiology and surveillance [[electronic resource] /] / editors, S. Lori Brown, Roselie A. Bright, and Dale R. Tavris
| Medical device epidemiology and surveillance [[electronic resource] /] / editors, S. Lori Brown, Roselie A. Bright, and Dale R. Tavris |
| Pubbl/distr/stampa | Chichester, West Sussex, England ; ; Hoboken, NJ, : John Wiley & Sons, c2007 |
| Descrizione fisica | 1 online resource (529 p.) |
| Disciplina | 610.28 |
| Altri autori (Persone) |
BrownS. Lori
BrightRoselie A TavrisDale R |
| Soggetto topico |
Medical instruments and apparatus - Standards - United States
Medical instruments and apparatus - Safety measures - United States |
| ISBN |
1-280-95629-1
9786610956296 0-470-06087-5 0-470-06086-7 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Medical 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
Surveillance 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 Utilization 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 9 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 The 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 Medical devices: the European directives and definitions |
| Record Nr. | UNINA-9910143716903321 |
| Chichester, West Sussex, England ; ; Hoboken, NJ, : John Wiley & Sons, c2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Medical device epidemiology and surveillance [[electronic resource] /] / editors, S. Lori Brown, Roselie A. Bright, and Dale R. Tavris
| Medical device epidemiology and surveillance [[electronic resource] /] / editors, S. Lori Brown, Roselie A. Bright, and Dale R. Tavris |
| Pubbl/distr/stampa | Chichester, West Sussex, England ; ; Hoboken, NJ, : John Wiley & Sons, c2007 |
| Descrizione fisica | 1 online resource (529 p.) |
| Disciplina | 610.28 |
| Altri autori (Persone) |
BrownS. Lori
BrightRoselie A TavrisDale R |
| Soggetto topico |
Medical instruments and apparatus - Standards - United States
Medical instruments and apparatus - Safety measures - United States |
| ISBN |
1-280-95629-1
9786610956296 0-470-06087-5 0-470-06086-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Medical 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
Surveillance 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 Utilization 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 9 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 The 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 Medical devices: the European directives and definitions |
| Record Nr. | UNINA-9910831163403321 |
| Chichester, West Sussex, England ; ; Hoboken, NJ, : John Wiley & Sons, c2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Medical device epidemiology and surveillance / / editors, S. Lori Brown, Roselie A. Bright, and Dale R. Tavris
| Medical device epidemiology and surveillance / / editors, S. Lori Brown, Roselie A. Bright, and Dale R. Tavris |
| Pubbl/distr/stampa | Chichester, West Sussex, England ; ; Hoboken, NJ, : John Wiley & Sons, c2007 |
| Descrizione fisica | 1 online resource (529 p.) |
| Disciplina | 610.28 |
| Altri autori (Persone) |
BrownS. Lori
BrightRoselie A TavrisDale R |
| Soggetto topico |
Medical instruments and apparatus - Standards - United States
Medical instruments and apparatus - Safety measures - United States |
| ISBN |
1-280-95629-1
9786610956296 0-470-06087-5 0-470-06086-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Medical 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
Surveillance 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 Utilization 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 9 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 The 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 Medical devices: the European directives and definitions |
| Record Nr. | UNINA-9910877722003321 |
| Chichester, West Sussex, England ; ; Hoboken, NJ, : John Wiley & Sons, c2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
