Medical devices approved without close scientific review

Congressional investigators have revealed that some medical devices used for sensitive procedures from hip joints to a type of defibrillator have got government approval without close scientific review.

According to the Government Accountability Office(GAO), the FDA approved 228 devices during 2003- 2007. Public Citizen reports that some of the approved devices had to be recalled back due to defects. One of these was a defibrillator which is used to assist heart attack patients.

"The report certainly confirms our suspicions that FDA uses a variety of means to lessen the regulatory burden on industry,'' said Dr. Peter Lurie, of the consumer advocacy group Public Citizen.

A week before the GAO submitted its report, a group of career scientists had written to the President-elect Barack Obama’s transition team about the “corrupted and distorted” practices in the review of scientific devices. The anonymous writers said that the managers in the FDA’s device department had threatened the FDA experts to change the scientific data to suit specific needs, which was against the laws.

The negligence on the part of the FDA officials could cause death in sensitive cases. Devices which are classified as high-risk need stringent scrutiny.

Manufacturers managed get approval for their sub standard devices by convincing the FDA officials that their products were equivalent to those of the predecessors. Though in 1990, the Congress had ordered the FDA to discontinue the practice, yet the FDA had ignored the orders and continued with the practice.

The GAO has asked the FDA to resolve the problem at the earliest.

Latest News

Father Shoots Girl’s Laptop, Posts Video on Youtube
Apple Begins Inspection
Researchers Blame Technological Advancements For Kids’ Poor Sleeping Pattern
The Google Motorola Deal Approved By US and EU
Replace Sugary Drinks with Water to Lose Weight
NASA Scientists Develop New Space Testbed
Scientists Expecting Life at Icy Dark and Cold Regions
Mysteries Behind Milky Way Galaxy To Be Unveiled
Scientific Equation behind the Shape of Ponytail Unveiled
Cooma People Encouraged To Donate Blood
Knox Receives Less Dental Care Funding
Massive Fight in Sydney Club