Medical Device Monitoring Needs Work - Report

WASHINGTON (Reuters) - U.S. health officials need a better system for tracking the safety of medical devices after they are approved for the sale, especially ones used to treat children, a report released on Monday said.

Dozens of medical devices are supposed to undergo further study after approval but regulators do a poor job of monitoring the research, the report by an Institute of Medicine (IOM) committee said.

The Food and Drug Administration could not say which trials had been started or completed or otherwise confirm their progress, the IOM report said. Nor 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.

"Currently no overall compilation or summary of information on study commitments or their status is available," the report said.

FDA officials said they had made improvements since the IOM collected its information, including establishing an electronic system to monitor the status of post-approval studies.

The IOM report "showed us a number of places ... we could improve. In a number of places, we have already taken actions," said Susan Gardner, director of the FDA's Office of Surveillance and Biometrics.

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.

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

Most devices are intended for, and studied in, adults, leaving questions about how the products perform in children over time. Children's rapid growth, smaller size and active lifestyles can impact longevity, effectiveness and safety of medical devices differently than they do in adults.

The IOM said Congress should 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 FDA also should make results easily accessible to the public, the report said.

"Better structured approaches to assure long-term monitoring of devices in children with potential for serious problems in the post-market environment - without overburdening an often fragile industry - will take careful management but we feel it must be done," the report said.