Advisory panel faults FDA's regulation of safety of medical devices

2-year investigation finds big loophole in oversight

July 19, 2005|By LOS ANGELES TIMES

WASHINGTON - Government regulators lack an effective system to monitor the safety of medical devices, which include items as diverse as incubators for premature babies, surgical clamps and cardiac pacemakers, a scientific panel concluded in a report issued yesterday.

The Food and Drug Administration, which is responsible for the safety of medical devices as well as drugs, needs additional legal authority from Congress and better internal procedures, according to an Institute of Medicine panel. The institute is affiliated with the National Academy of Sciences.

An FDA official said the report was constructive.

The panel found "some shortfalls" and "deficits" with FDA oversight of medical devices.

Congress originally instructed the panel to evaluate how well the FDA tracks safety problems in medical devices made for children. But after nearly two years of study, panel members concluded that similar shortcomings compromised the oversight of medical devices for adults.

About 80,000 types of medical devices are sold in the United States. Last year the government received about 152,000 reports of safety problems, with children involved in 2,700 of those cases.

Medical devices gained attention recently when Guidant Corp. recalled about 100,000 defibrillators meant to be implanted in patients. The compact devices are designed to monitor a patient's heart and administer electrical shocks when needed to correct potentially lethal heartbeat irregularities. But it was discovered that a short circuit could cause some units to fail without warning, depriving patients of a potentially lifesaving jolt.

Guidant also warned physicians yesterday that replacements might be needed for nine pacemaker models made between 1997 and 2000.

The panel found that such critical high-stakes devices receive close scrutiny from the FDA; the major loophole in oversight, it said, has to do with a broad group of intermediate-risk devices that go through what the agency calls "clearance."

The Los Angeles Times is a Tribune Publishing newspaper.

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