FDA has approved 228 medical devices without full scale reviews from the years 2003-2007 according to a report by the Government Accountability Office reports Fox News. This happened even though Congress ordered FDA years ago to resolve this particular issue.
As a result of no full scale review, some of the medical devices approved have been recalled because of malfunctions. Fox news reports one of the devices was an external defibrillator to assist heart attack victims.
Rep. Frank Pallone, head of the House of Energy and Commerce Committee’s health panel said, “GAO’s investigation confirms my concerns that the approval process for medical devices is woefully inadequate. 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.”
FDA is the root of the problem seeing as they never carried out the change of law when Congress ordered them to resolve this issue.
For devices that are low-risk (reading glasses or bandages), they can get cleared by notifying FDA before going to the market. The process is different for high-risk devices such as heart valves or pacemakers. These devices should go through a higher, tighter scrutiny. The manufacturers are required to prove with evidence that the medical devices are safe and effective. However, an exception was made for new versions of the high-risk medical devices already on the market. Apparently, “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.”
FDA is aware of this problem and has not set a time for resolving it. The report urges the FDA to “promptly resolve the problem.”
If FDA continues to allow medical devices into the market without undergoing a tighter scrutiny review, “it’s placing tens of thousands of Americans at risk,” said Peter Lurie, deputy director of Public Citizen’s health research group.