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

High profile device failures have highlighted the inadequacies of current regulation. Art Sedrakyan and colleagues call for a move to a graduated model of approval and suggest a framework to achieve this goal

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Bibliographic Details
Published in:BMJ (Online) 2016-06, Vol.353, p.i2372-i2372
Main Authors: Sedrakyan, Art, Campbell, Bruce, Merino, Jose G, Kuntz, Richard, Hirst, Allison, McCulloch, Peter
Format: Article
Language:English
Subjects:
Analysis
Cohort analysis
Collaboration
Device Approval - legislation & jurisprudence
Device Approval - standards
Equipment Design - methods
Equipment Design - standards
Equipment Safety - methods
Equipment Safety - standards
FDA approval
Humans
Innovations
Learning curves
Medical device industry
Medical Device Legislation
Medical equipment
Medical technology
Product life cycle
Quality control
Quality standards
Registration
Regulation
Studies
Surgery
Surveillance
Transplants & implants
United Kingdom
United States
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Description
Summary:High profile device failures have highlighted the inadequacies of current regulation. Art Sedrakyan and colleagues call for a move to a graduated model of approval and suggest a framework to achieve this goal
ISSN:1756-1833
1756-1833
DOI:10.1136/bmj.i2372