Medical devices

What's inside your body?

FDA faulted for clearing some high risk medical devices
without rigorous review
Thursday, January 15, 2009 16:51 EST


WASHINGTON -- Some medical devices for sensitive uses, from certain hip
joints to a type of defibrillator, have won government approval without a
close scientific review, congressional investigators said Thursday.

Although Congress ordered the Food and Drug Administration years ago to
resolve the issue, the agency approved 228 medical devices without a full
scale review from 2003-2007, the Government Accountability Office said in a
report.

Some devices approved under the less rigorous process have been recalled
because of malfunctions and other problems, according to the consumer group
Public Citizen. One device was an external defibrillator to assist heart
attack victims.

The report comes as the FDA's Center for Devices and Radiological Health is
the subject of allegations that scientists were pressured to approve medical
machinery against their professional judgment. Nine FDA scientists wrote the
Obama transition team last week complaining that a "corrupted" review
process is putting public health at risk.

The allegations are a separate matter from the concerns raised in Thursday's
report. But taken together, they probably will raise the level of
congressional scrutiny over the FDA's medical devices branch.

"GAO's investigation confirms my concerns that the approval process for
medical devices is woefully inadequate," said Rep. Frank Pallone, who heads
the House Energy and Commerce Committee's health panel. "For years, Congress
has required high-risk medical devices to undergo stringent premarket
review, but GAO's findings show that is simply not happening in every case."

Pallone, D-N.J., said he intends to hold hearings on the FDA's oversight of
medical devices. The GAO did not look into whether any patients were harmed
as a result of devices that got less government scrutiny.

The root of the problem seems to be that the FDA never fully carried out the
intent of a decades-old change in the law.

Medical devices include everything from tongue depressors to silicone breast
implants and pacemakers. In 1976, Congress set up a three-tiered
classification system for devices.

Manufacturers of low-risk devices such as bandages and reading glasses could
get cleared by notifying the FDA before going to market. High-risk devices
such as pacemakers and heart valves would have to go through tighter
scrutiny, and their manufacturers were required to provide evidence of
safety and effectiveness. Devices classified as high-risk tended to be ones
that are implanted in the body or could spell the difference between life
and death.

An exception was carved out for new versions of high-risk devices already on
the market.

Manufacturers could get approval by convincing the FDA that these devices
were "substantially equivalent" to their precursors. In 1990, Congress
ordered the FDA to end the practice, but it has continued even as
generations of technology have come and gone.

The report urged the FDA to promptly resolve the problem, either by carrying
out full reviews or reclassifying some devices as lower risk, if
appropriate.

The FDA acknowledged the problem, but has not set a timetable for resolving
it. "In general, we agree with the conclusions and recommendations," said
spokeswoman Karen Riley. "We are considering legal and procedural options to
accomplish this objective."

The GAO report found that two-dozen distinct types of devices approved
without close scrutiny, including metal hip joints, external defibrillators,
and electrodes for pacemakers.

"It all adds up to less-than-rigorous device review, and it's placing tens
of thousands of Americans at risk," said Peter Lurie, deputy director of
Public Citizen's health research group.

___

On the Net:

GAO report: http://tinyurl.com/73nyhl

___ Blue Wave/QWK v2.12
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