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.
KEY WORDS: medical technology - health professions - safety - health care quality