IDEAL-D: a rational framework for evaluating and regulating the use of medical devices

被引：172

作者：

Sedrakyan, Art ^{[1
,2
]}

Campbell, Bruce ^{[3
]}

Merino, Jose G. ^{[4
]}

Kuntz, Richard ^{[5
]}

Hirst, Allison ^{[6
]}

McCulloch, Peter ^{[6
]}

机构：

[1] Cornell Univ, Weill Med Coll, Dept Healthcare Policy & Res, New York, NY 10021 USA

[2] Cornell Univ, Weill Med Coll, Med Device Epidemiol Network MDEpiNet, Sci & Infrastruct Ctr, New York, NY 10021 USA

[3] Natl Inst Hlth & Care Excellence, Intervent Procedures Programme, London, England

[4] Johns Hopkins Community Phys, Bethesda, MD USA

[5] Medtronic, Minneapolis, MN USA

[6] Univ Oxford, Nuffield Dept Surg Sci, Oxford, England

来源：

BMJ-BRITISH MEDICAL JOURNAL | 2016年 / 353卷

关键词：

RANDOMIZED CONTROLLED-TRIALS; METAL; FAILURE;

D O I：

10.1136/bmj.i2372

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

[No abstract available]

引用

页数：7

共 28 条

[1]

[Anonymous], TRANSCR PUBL WORKSH

[2]

[Anonymous], PRINC GUID REP PRECL

[3] The 510(k) Ancestry of a Metal-on-Metal Hip Implant [J].

Ardaugh, Brent M. ;

Graves, Stephen E. ;

Redberg, Rita F. .

NEW ENGLAND JOURNAL OF MEDICINE, 2013, 368 (02) :97-100

[4] Surgical Innovation and Evaluation 1 Evaluation and stages of surgical innovations [J].

Barkun, Jeffrey S. ;

Aronson, Jeffrey K. ;

Feldman, Liane S. ;

Maddern, Guy J. ;

Strasberg, Steven M. .

LANCET, 2009, 374 (9695) :1089-1096

[5] Implementing Unique Device Identification in Electronic Health Record Systems Organizational, Workflow, and Technological Challenges [J].

Campion, Thomas R. ;

Johnson, Stephen B. ;

Paxton, Elizabeth W. ;

Mushlin, Alvin I. ;

Sedrakyan, Art .

MEDICAL CARE, 2014, 52 (01) :26-31

[6] Safety and Procedural Success of Left Atrial Appendage Exclusion With the Lariat Device A Systematic Review of Published Reports and Analytic Review of the FDAMAUDE Database [J].

Chatterjee, Saurav ;

Herrmann, Howard C. ;

Wilensky, Robert L. ;

Hirshfeld, John ;

McCormick, Daniel ;

Frankel, David S. ;

Yeh, Robert W. ;

Armstrong, Ehrin J. ;

Kumbhani, Dharam J. ;

Giri, Jay .

JAMA INTERNAL MEDICINE, 2015, 175 (07) :1104-1109

[7]

Chick S, 2015, BAYESIAN DECISION TH

[8] IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage [J].

Cook, Jonathan A. ;

McCulloch, Peter ;

Blazeby, Jane M. ;

Beard, David J. ;

Marinac-Dabic, Danica ;

Sedrakyan, Art .

BMJ-BRITISH MEDICAL JOURNAL, 2013, 346

[9] Progress and Current Status of Percutaneous Aortic Valve Replacement: Results of Three Device Generations of the CoreValve Revalving System [J].

Grube, Eberhard ;

Buellesfeld, Lutz ;

Mueller, Ralf ;

Sauren, Barthel ;

Zickmann, Bernfried ;

Nair, Dinesh ;

Beucher, Harald ;

Felderhoff, Thomas ;

Iversen, Stein ;

Gerckens, Ulrich .

CIRCULATION-CARDIOVASCULAR INTERVENTIONS, 2008, 1 (03) :167-175

[10] Which Factors Determine the Wear Rate of Large-Diameter Metal-on-Metal Hip Replacements? [J].

Hart, A. J. ;

Muirhead-Allwood, S. ;

Porter, M. ;

Matthies, A. ;

Ilo, K. ;

Maggiore, P. ;

Underwood, R. ;

Cann, P. ;

Cobb, J. ;

Skinner, J. A. .

JOURNAL OF BONE AND JOINT SURGERY-AMERICAN VOLUME, 2013, 95A (08) :678-685

← 1 2 3 →