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Improving Medical Device Safety


Medical devices—everything from pacemakers to blood pressure cuffs, surgical mesh to stitches—have become increasingly important in maintaining Americans’ health as the population ages and technology advances. But the system for approving medical devices for sale to consumers and then monitoring their effectiveness and the risk of complications has not kept up with increased usage and advancing technology.

Pre-market review of medical device safety by the Food and Drug Administration (FDA) is governed by 1976 Medical Device Amendments to the FDA’s enabling legislation. This legislation divided medical devices into classes based on risk to human health with Class I as the lowest-risk and Class III as the highest-risk category, and then subjected new devices in each category to increasing levels of pre-market scrutiny. Unfortunately, as the number of medical devices has skyrocketed, limited pre-market scrutiny and post-market reporting may prove inadequate to protect consumer and patient health.

A 2011 report by the venerable Institute of Medicine indicates the extent of the problem: the current FDA program for clearing medical devices for the consumer market “lacks the statutory basis to make it a reliable pre-market screen for safety and effectiveness.” Furthermore, a program for robust and reliable post-market reporting needs to be established in order to allow for quick and accurate assessment of medical device safety.

Many products are used by relatively few patients, so the FDA faces difficulty in gathering enough data to draw statistically-sound conclusions about the risks associate with new products. The report recommends that the FDA concentrate its energy on developing scientifically-based pre-market screening and more robust post-market reporting systems rather than trying to repair a 36 year-old screening process that does not live up to its legislative mandate.

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