Health Highlights: Jan. 16, 2009

Jan. 17 -- Here are some of the latest health and medical news developments, compiled by editors of HealthDay:

FDA Lax in Review of High-Risk Medical Devices: Report

From 2003 to 2007, the U.S. Food and Drug Administration approved some 228 medical devices -- some of them for sensitive uses -- without a full scale review, a Government Accountability Office (GAO) report said Thursday.

The report found that two dozen distinct types of devices -- such as metal hip joints, external defibrillators to assist heart attack victims, and electrodes for pacemakers -- were approved without close scrutiny, the Associated Press said.

Some devices approved have been recalled because of malfunctions and other problems, according to the consumer group Public Citizen. "It all adds up to less-than-rigorous device review, and it's placing tens of thousands of Americans at risk," Peter Lurie, deputy director of Public Citizen's health research group, told the news service.

While the report did not look into whether any patients were harmed as a result of the approvals, it does highlight calls for closer scrutiny of the FDA's medical device approval process, which has been subject to charges that scientists were pressured to OK some medical machinery against their professional judgment, the AP said.

In 1976, Congress established a three-tiered classification system for these devices, which include everything from tongue depressors to silicone breast implants to pacemakers, the AP said. Low-risk devices such as bandages could be cleared by notifying the FDA before going to market, while high-risk devices such as pacemakers would face tighter scrutiny. Manufacturers were required to provide evidence of safety and effectiveness, but subsequent gains in technology have increased not only the number of devices coming to market but also the number of upgraded products coming up for review, the news service said.

"In general, we agree with the conclusions and recommendations," FDA spokeswoman Karen Riley said. "We are considering legal and procedural options to accomplish this objective."