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- Title
Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment.
- Authors
Feldman, Mitchell D.; Petersen, Amy J.; Karliner, Leah S.; Tice, Jeffrey A.
- Abstract
<bold>Introduction: </bold>The global medical technology industry brings thousands of devices to market every year. However, significant gaps persist in the scientific literature, in the medical device approval process, and in the realm of postmarketing surveillance. Although thousands of drugs obtain approval only after review in randomized controlled trials, relatively few new medical devices are subject to comparable scrutiny.<bold>Objective: </bold>To improve health outcomes, we must enhance our scrutiny of medical devices, and, without simply deferring to the Food and Drug Administration, we must ask ourselves: Who is responsible for evaluating the safety and effectiveness of medical devices?<bold>Conclusions: </bold>Technology assessments by independent organizations are a part of the solution to this challenge and may motivate further research focused on patient outcomes.
- Subjects
UNITED States; MEDICAL equipment; TECHNOLOGICAL innovations; CLINICAL trials; MEDICAL technology; TECHNOLOGY &; state; BIOMEDICAL engineering; MEDICAL supplies; MEDICAL equipment laws; EQUIPMENT &; supply standards; QUALITY assurance standards; MEDICAL quality control; RESEARCH; RESEARCH methodology; EVIDENCE-based medicine; MEDICAL cooperation; EVALUATION research; UNITED States. Food &; Drug Administration; MEDICAL equipment safety measures; PRODUCT design; COMPARATIVE studies; GROUP decision making; NEW product development laws
- Publication
JGIM: Journal of General Internal Medicine, 2008, Vol 23, Issue S1, p57
- ISSN
0884-8734
- Publication type
journal article
- DOI
10.1007/s11606-007-0275-4