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Volumn 342, Issue 7807, 2011, Pages

Medical device recalls and transparency in the UK

Author keywords

[No Author keywords available]

Indexed keywords

DEFIBRILLATOR; DEVICE APPROVAL; DEVICE RECALL; DEVICE SAFETY; IMPLANT; MORBIDITY; MORTALITY; NATIONAL HEALTH SERVICE; PACEMAKER; PRIMARY MEDICAL CARE; PRIORITY JOURNAL; RISK ASSESSMENT; SHORT SURVEY; UNITED KINGDOM; ARTICLE; EQUIPMENT; INFORMATION DISSEMINATION; UNITED STATES;

EID: 79956296633     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.d2973     Document Type: Short Survey
Times cited : (32)

References (13)
  • 2
    • 84857863524 scopus 로고    scopus 로고
    • Medical-device recalls in the UK and the device-regulation process: Retrospective review of safety notices and alerts
    • doi:10.1136/bmjopen-2011-000155
    • Heneghan C, Thompson M, Billingsley M, Cohen D. Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts. BMJ Open doi:10.1136/bmjopen-2011-000155
    • BMJ Open
    • Heneghan, C.1    Thompson, M.2    Billingsley, M.3    Cohen, D.4
  • 3
    • 79955726540 scopus 로고    scopus 로고
    • Medical device recalls and the FDA approval process
    • Feb 14 [Epub ahead of print]
    • Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med 2011 Feb 14 [Epub ahead of print].
    • (2011) Arch Intern Med
    • Zuckerman, D.M.1    Brown, P.2    Nissen, S.E.3
  • 4
    • 77955016199 scopus 로고    scopus 로고
    • Left to their own devices: Breakdowns in United States medical device premarket review
    • Hines JZ, Lurie P, Yu E, Wolfe S. Left to their own devices: breakdowns in United States medical device premarket review. PLoS Med 2010;7:e1000280.
    • (2010) PLoS Med , vol.7
    • Hines, J.Z.1    Lurie, P.2    Yu, E.3    Wolfe, S.4
  • 5
    • 78049522356 scopus 로고    scopus 로고
    • Regulation of devices
    • Avorn J. Regulation of devices . BMJ 2010;341:c5730.
    • (2010) BMJ , vol.341
    • Avorn, J.1
  • 6
    • 73949084847 scopus 로고    scopus 로고
    • Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices
    • Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA 2009;302:2679-85.
    • (2009) JAMA , vol.302 , pp. 2679-2685
    • Dhruva, S.S.1    Bero, L.A.2    Redberg, R.F.3
  • 8
    • 0039432624 scopus 로고    scopus 로고
    • MHRA. Medical devices directive www.mhra.gov.uk/Howweregulate/Devices/ MedicalDevicesDirective/index.htm.
    • Medical Devices Directive
  • 9
    • 78049524215 scopus 로고    scopus 로고
    • Why the FDA can't protect the public
    • Lenzer J, Brownlee S. Why the FDA can't protect the public. BMJ 2010;341:c4753.
    • (2010) BMJ , vol.341
    • Lenzer, J.1    Brownlee, S.2
  • 11
    • 84859009469 scopus 로고    scopus 로고
    • EU must tackle clinical trials shortfalls as current lack of evidence is "appalling"
    • 26 July
    • Maxwell A. EU must tackle clinical trials shortfalls as current lack of evidence is "appalling." Clinica 26 July, 2010www.clinica.co.uk/ policyregulation/regulation/EU-must-tackle-clinical-trials-shortfalls-as- current-lack-of-evidence-is-appalling-300097?autnID=/contentstore/clinica/codex/ 1c3de0ae-957a-11df-85a6-3fb6c851cb0a.xml.
    • (2010) Clinica
    • Maxwell, A.1
  • 13
    • 84859006331 scopus 로고    scopus 로고
    • European Commission. Proposal for a directive/regulation. 2011 http://ec.europa.eu/governance/impact/planned-ia/docs/80-sanco-medical-devices- en.pdf.
    • (2011) Proposal for A Directive/regulation


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.