A report released Thursday by congressional investigators shows that the Food and Drug Administration (FDA) is allowing some high risk medical devices to be approved without the close scientific review required by law. The Government Accountability Office (GAO), Congress' audit, evaluation and investigative arm, says that despite a Congressional order in 1990 to resolve the issue, the FDA approved 228 medical devices between 2003 and 2007 without a complete review of their safety and effectiveness.

The report found that two-dozen distinct types of devices approved without close scrutiny, including metal hip joints used in hip replacement surgery, external defibrillators used to rescue people who are having a heart attack, and electrodes for pacemakers.

The problem arises from a 1976 law that implemented a three-tiered classification scheme to categorize medical devices. That law divides medical devices into three classes: class I devices are low risk such as reading glasses and tongue depressors, class II includes devices with more risk such as electrocardiograph (ECG) machines and mercury thermometers, and class III devices are considered high-risk because they are implanted in the body or they can mean the difference between life and death, such as pacemakers and replacement heart valves.

Manufacturers of high-risk devices are required to demonstrate the safety and effectiveness of their device before taking it to market. However, an exception was written into the law that allows new versions of already-approved high-risk devices to bypass this step. In order to get a new device approved this way, manufactures must simply demonstrate that their new device is “substantially equivalent” to an existing device. This leaves a lot of room for interpretation, so in 1990, Congress ordered the FDA to stop approving devices in this way. The GAO report shows that despite agreeing in principle, the FDA has not fulfilled its promise.

Some of the high-risk devices approved this way have been removed from the market. The GAO study did not examine whether anyone was harmed as a result of using the un-scrutinized devices.

The GAO report urges the FDA to act quickly to end this method of approving high-risk devices. They also suggest that the FDA carry out full reviews of the devices already approved this way and reclassify devices as lower risk where appropriate.

Read the full GAO report at the GAO Web site. If you have a question about medical devices, ask the experts at Healia Health Communities.


_{Photo: Olaf, Flickr, Creative Commons}