Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment.

Abstract

INTRODUCTION: 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. OBJECTIVE: 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? CONCLUSIONS: Technology assessments by independent organizations are a part of the solution to this challenge and may motivate further research focused on patient outcomes.