Commentary: International collaboration needed on device clinical standards

BMJ

Volumn 342, Issue 7807, 2011, Pages

  Fraser, Alan G ^a   Krucoff, Mitchell W ^b   Brindis, Ralph G ^c,f   Komajda, Michel ^d,g   Smith Jr , Sidney C ^e,h  

^a CARDIFF UNIVERSITY   (United Kingdom)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

^c KAISER PERMANENTE   (United States)

^d PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^e UNIVERSITY OF NORTH CAROLINA   (United States)

^f AMERICAN COLLEGE OF CARDIOLOGY   (United States)

^g European Society of Cardiology   (France)

^h WORLD HEART FEDERATION   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL EVALUATION; DEVICE APPROVAL; DEVICE SAFETY; MEDICAL PROFESSION; NOTE; PATIENT SAFETY; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; STANDARDIZATION; ARTICLE; EUROPE; INTERNATIONAL COOPERATION; PROSTHESES AND ORTHOSES; STANDARD; UNITED STATES;

EUROPE; INTERNATIONAL COOPERATION; PROSTHESES AND IMPLANTS; REFERENCE STANDARDS; UNITED STATES;

EID: 79956298364     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.d2952     Document Type: Note

References (6)

1. Fraser AG, Daubert JC, Van de Werf F, Estes NA, Smith SC Jr, Krucoff MW, et al. Clinical evaluation of cardiovascular devices - principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European Society of Cardiology. Eur Heart J 2011 http://eurheartj. oxfordjournals.org/cgi/reprint/ehr171.
2. Richwine L. Guinea pig' comment sparks US, EU device spat. Reuters 25 Feb 2011. http://in.mobile.reuters.com/article/worldNews/idINIndia-55143020110224
3. WHO. Medical device regulations: global overview and guiding principles. WHO, 2003.
4. WHO. Preliminary results of the baseline country survey on medical devices. 2010 www.who.int/medical-devices/survey-preliminary-results/en/index4. html.
5. World Health Organization. Medium-term strategic plan 2008-2013. WHO, 2008:89.
6. Global Harmonization Task Force. Statement from the chair - update on future directions of GHTF, 2011. http://ghtf.org/documents/statement-future- 2011.pdf.