Some Medical Devices Escaping Close FDA Review

March 18, 2009
by: Spine-health Staff Writer

Recently, congressional investigators have reported that several medical devices, ranging from certain hip joints to a type of defibrillator, have received FDA approval without close scientific review. The Government Accountability Office reported that the agency approved 228 medical devices without full review from 2003-2007. Some of these lesser-reviewed products have been recalled due to malfunctions and other problems; one device was an external defibrillator to assist heart attack victims.

The GAO report was released as the FDA’s Center for Devices and Radiological Health was the subject of allegations claiming that scientists were pressured to approve medical devices against their professional judgment. Nine FDA scientists recently wrote the Obama transition team complaining that a “corrupted” review process was putting public health at great risk. These matters will surely raise the level of congressional scrutiny over the FDA’s medical devices branch.

In 1976, Congress set up a three-tiered classification system for medical devices. Low-risk devices, like bandages and reading glasses, could gain approval simply by notifying the FDA before going to market. High-risk devices—mostly devices implanted in the body, like pacemakers and heart valves—required tighter scrutiny, and manufacturers were required to provide evidence of the product’s safety and effectiveness.

The problems began when exceptions were made for improvements to devices already on the market. Manufacturers simply had to convince the FDA that the devices were “substantially equivalent” to their precursors. In 1990, Congress ordered the FDA to stop this practice, but it continues to go on, even today.

The FDA has acknowledged the problem, but has not committed to how or when they are going to resolve it. Current suggestions include either carrying out full reviews of all products, or reclassifying some devices as lower risk, if appropriate. The GAO report found at least two-dozen distinct types of devices that have escaped close scrutiny, including metal hip joints, external defibrillators, and electrodes for pacemakers, potentially putting patients around the world at risk.

Patients considering back or neck surgery should ask their surgeon about the spinal devices he/she plans to use and understand important factors such as FDA labeling, time on market, number of patients implanted, etc. Patients should feel completely comfortable about the choice of devices for their spine surgery and have a right to know what will be used and why.

By: Spine-health staff writer

Sources:

High risk medical devices escaped close review, ABC News/Associated Press

GAO Report

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