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http://www.nytimes.com/aponline/health/AP-FDA-Devices.html

FDA to Require Tracking Risky Devices

By THE ASSOCIATED PRESS

Filed at 5:43 p.m. ET

WASHINGTON (AP) -- Federal health officials will begin requiring makers of certain high-risk medical devices to closely track how well they work in patients.

The new rules mark an effort to better identify dangerous side effects that are too rare to fully evaluate in studies before a device is sold. Tracking may help solve other quandaries, such as whether recalling and repairing a medical device took care of a threat.

The Food and Drug Administration largely depends on an underused program in which doctors voluntarily report problems in devices that may need to be recalled or even pulled off the market.

A 1990 federal law did require the FDA to order close tracking -- called surveillance -- of certain implanted devices, after the belated discovery that an artificial heart valve popular in the 1980s had a deadly defect.

By the late 1990s, the FDA was calling that law self-defeating: It brought in reams of data about old devices like pacemakers, whose risks were well known. But it didn't give the FDA time or money to focus on products officials thought posed more of a risk, such as newer devices whose side effects aren't yet fully understood, said FDA biologist Laura Alonge.

Congress in 1997 authorized a change, allowing the FDA to choose which devices need such close tracking.

After five years of review, the FDA announced rules Wednesday that would lead to surveillance of, at most, 30 devices a year. Tracking could be used for the most high-risk, complex devices; life-supporting or sustaining devices used outside a health facility; long-term implants; or devices where failure will probably cause serious consequences.

Examples being tracked include a break-prone patch for life-threatening abdominal aortic aneurysms, and home kits that perform crucial tests of Coumadin users' blood-clotting ability.

Device makers declined comment.

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