Regulation of medical devices used in diabetology in Europe: Time for reform?

被引：10

作者：

Boulton, A. J. M. ^{[1
]}

Del Prato, S. ^{[1
]}

机构：

[1] European Assoc Study Diabet, D-40591 Dusseldorf, Germany

来源：

DIABETOLOGIA | 2012年 / 55卷 / 08期

关键词：

Clinical diabetes; Devices; Insulin therapy; GLUCOSE;

D O I：

10.1007/s00125-012-2580-7

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

引用

页码：2295 / 2297

页数：3

共 20 条

[1]

Battelino Tadej, 2004, Pediatr Endocrinol Rev, V1 Suppl 3, P537

[2] Clinical Use of Real-Time Continuous Glucose Monitoring [J].

Battelino, Tadej ;

Bolinder, Jan .

CURRENT DIABETES REVIEWS, 2008, 4 (03) :218-222

[3] The PIP mammary prosthesis: A product recall study [J].

Berry, M. G. ;

Stanek, Jan J. .

JOURNAL OF PLASTIC RECONSTRUCTIVE AND AESTHETIC SURGERY, 2012, 65 (06) :697-704

[4] MEDICAL DEVICES How safe are metal-on-metal hip implants? [J].

Cohen, Deborah .

BRITISH MEDICAL JOURNAL, 2012, 344

[5]

EASD, 2012, DIABETOLOGIA NEW JUN

[6]

European Commission, 2010, MED DEV GUID DOC CLA

[7] Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform Report of a policy conference of the European Society of Cardiology [J].

Fraser, Alan G. ;

Daubert, Jean-Claude ;

Van de Werf, Frans ;

Estes, N. A. Mark, III ;

Smith, Sidney C., Jr. ;

Krucoff, Mitchell W. ;

Vardas, Panos E. ;

Komajda, Michel .

EUROPEAN HEART JOURNAL, 2011, 32 (13) :1673-1686D

[8] Deaths caused by the failure of Riata and Riata ST implantable cardioverter-defibrillator leads [J].

Hauser, Robert G. ;

Abdelhadi, Raed ;

McGriff, Deepa ;

Retel, Linda Kallinen .

HEART RHYTHM, 2012, 9 (08) :1227-1235

[9] Here We Go Again - Another Failure of Postmarketing Device Surveillance [J].

Hauser, Robert G. .

NEW ENGLAND JOURNAL OF MEDICINE, 2012, 366 (10) :873-875

[10] Offline: The scandal of device regulation in the UK [J].

Horton, Richard .

LANCET, 2012, 379 (9812) :204-204

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