Postmarket surveillance of high-risk medical devices needs transparent, comprehensive and independent registries

被引:4
|
作者
Fraser, Alan G. [1 ]
机构
[1] Univ Hosp Wales, Dept Cardiol, Cardiff, Wales
关键词
real world evidence; active surveillance; health care costs; cardiac devices;
D O I
10.1136/bmjsit-2020-000065
中图分类号
R61 [外科手术学];
学科分类号
摘要
[No abstract available]
引用
收藏
页数:3
相关论文
共 50 条
  • [1] Postmarket Modifications of High-risk Plastic Surgery Devices
    Olaiya, Oluwatobi R.
    Oyesile, Doyinsola
    Stone, Nicholas
    Mbuagbaw, Lawrence
    McRae, Mark H.
    [J]. PLASTIC AND RECONSTRUCTIVE SURGERY-GLOBAL OPEN, 2020, 8 (02)
  • [2] EU postmarket surveillance plans for medical devices
    Pane, Josep
    Francisca, Reynold D. C.
    Verhamme, Katia M. C.
    Orozco, Marcia
    Viroux, Hilde
    Rebollo, Irene
    Sturkenboom, Miriam C. J. M.
    [J]. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2019, 28 (09) : 1155 - 1165
  • [3] Current development in medical devices postmarket surveillance in Taiwan
    Lan, Cheng-Wen
    Yeh, Ming-Kung
    Wu, Shiow-Ing
    Tu, Pei-Weng
    [J]. JOURNAL OF FOOD AND DRUG ANALYSIS, 2015, 23 (01) : 164 - 165
  • [4] Blockchain technology applications to postmarket surveillance of medical devices
    Pane, Josep
    Verhamme, Katia M. C.
    Shrum, Lacey
    Rebollo, Irene
    Sturkenboom, Miriam C. J. M.
    [J]. EXPERT REVIEW OF MEDICAL DEVICES, 2020, 17 (10) : 1123 - 1132
  • [5] THE SAFE MEDICAL DEVICES ACT OF 1990 - POSTMARKET SURVEILLANCE, MDR, AND OTHER POSTMARKET ISSUES
    BASILE, EM
    [J]. FOOD AND DRUG LAW JOURNAL, 1991, 46 (02): : 165 - 175
  • [6] Postmarket surveillance of medical devices: current capabilities and future opportunities
    Kathleen Blake
    [J]. Journal of Interventional Cardiac Electrophysiology, 2013, 36 : 119 - 127
  • [7] Postmarket surveillance for medical devices: America's new strategy
    Normand, Sharon-Lise T.
    Hatfield, Laura
    Drozda, Joseph
    Resnic, Frederic S.
    [J]. BRITISH MEDICAL JOURNAL, 2012, 345
  • [8] Postmarket surveillance of medical devices: current capabilities and future opportunities
    Blake, Kathleen
    [J]. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY, 2013, 36 (02) : 119 - 127
  • [9] Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance
    Kramer, Daniel B.
    Baker, Matthew
    Ransford, Benjamin
    Molina-Markham, Andres
    Stewart, Quinn
    Fu, Kevin
    Reynolds, Matthew R.
    [J]. PLOS ONE, 2012, 7 (07):
  • [10] Innovation for Safe and Effective Medical Devices: Contributions From Postmarket Surveillance
    Claus Zippel
    Sabine Bohnet-Joschko
    [J]. Therapeutic Innovation & Regulatory Science, 2017, 51 : 237 - 245