Stricter Regulation of Medical Devices Clears House


Responding to reports of inadequate regulatory safeguards, Congress took a major step Wednesday toward adopting legislation to strengthen federal oversight of medical devices ranging from pacemakers to pediatric cribs.

The House unanimously passed a bill that would require the Food and Drug Administration to conduct timely reviews of the safety and effectiveness of new medical devices coming on the market. It also would give the FDA new authority to recall devices that pose a significant risk and impose stiff fines on companies that violate the law.

In addition, the measure would require hospitals and nursing homes to report directly to the FDA deaths and other serious problems associated with medical devices and would provide legal protections for those who do so.

The proposals would be the first major revisions of a much-criticized 1976 law under which the FDA regulates more than 1,700 types of medical devices used by health-care professionals to diagnose and treat illness.


Two congressional studies found last fall that manufacturers of medical devices were failing to notify federal officials of potentially dangerous defects, deciding for themselves whether to recall faulty equipment.

In two celebrated cases, dozens of crib deaths have been attributed to respiratory monitors made by Aequitron Medical Inc., of Plymouth, Minn., and at least 246 people have died as a result of fractures that developed in mechanical heart valves made by Shiley Inc., of Irvine. Both firms have denied wrongdoing.

“Clearly the law has not worked as intended, and reform is urgently needed,” said Rep. Henry A. Waxman (D-Los Angeles), the bill’s sponsor. The reform measure, he said, would “give the American people greater protection against dangerous medical devices.”

A similar bill sponsored by Sen. Edward M. Kennedy (D-Mass.) is awaiting action in the Senate. The major difference is that Kennedy’s bill does not contain civil penalties for firms that violate the medical device law.


The Bush Administration appears supportive of the reforms, House and Senate aides said. The medical devices industry, which generates $14 billion in annual sales, supports the Kennedy bill but opposes the fines proposed in the House version.