Better tracking system needed to check the safety of new medical devices

Jul 19 2005

A recently released report by the Institute of Medicine (IOM) says that a better system is needed by U.S. health officials for tracking the safety of medical devices after they are approved for sale, especially ones used to treat children.

The report says dozens of medical devices are supposed to undergo further study after approval but regulators do a poor job of monitoring the research.

According to the IOM report, the Food and Drug Administration (FDA) are unable to say which trials have been started or completed, or otherwise confirm their progress, and neither could the agency identify which studies involved children or focused on issues unique to them, such as how rapid growth can affect a device's performance.

It says currently there is not available, an overall compilation or summary of information on study commitments or their status.

Susan Gardner, director of the FDA's Office of Surveillance and Biometrics, says in defense that they have made improvements since the IOM collected its information, including establishing an electronic system to monitor the status of post-approval studies.

The IOM is an independent, nonprofit body that studies scientific matters, mostly for government agencies.

The IOM developed the medical device report in response to a request from Congress.

The new report, critiquing the FDA's device monitoring, follows more than a year of scrutiny of how the agency tracks the safety of prescription drugs after approval.

Apparently more than 80,000 medical devices are sold in the United States, and they range from simple products such as plastic tubing and hospital bedrails, to complicated devices such as implanted heart pacemakers and respirators for infants.

As most devices are intended for, and studied in, adults, questions often remain unanswered about how the products perform in children over time.

The IOM is suggesting that Congress broaden the FDA's power to require post-approval studies and make sure the agency sets up a reliable system to track the studies.

The committee also wants the FDA to make results easily accessible to the public.