Health Highlights: April 8, 2009

April 9 -- Here are some of the latest health and medical news developments, compiled by editors of HealthDay:

FDA Orders Safety Review for 25 Older Medical Devices

Manufacturers of 25 types of medical devices marketed prior to 1976 will have to submit safety data to the U.S. Food and Drug Administration, so it can determine their risk to consumers, the Wall Street Journal reported Wednesday.

The announcement follows a Government Accountability Office (GAO) report released in January that criticized the FDA's review of medical devices. The report's authors urged the agency to take immediate steps to ensure that high-risk items, such as external cardiac compressors and certain parts for pacemakers, get approval through strict review rather than just clearance.

FDA spokeswoman Mary Long told the Journal that it was unclear whether all of the devices will meet the stricter standards. If they don't, she said, there is a possibility they may be removed from the market.

-----

FDA Approves Faster Bird Flu Test

A new, quicker bird flu test for humans has been approved by the U.S. Food and Drug Administration.

The test detects influenza A/H5N1 in throat or nose swabs collected from patients with flu-like symptoms. In less than 40 minutes, the test identifies a specific protein (NS1) that indicates the presence of the influenza A/H5N1 virus subtype. Previously FDA-approved tests took three to four hours to identify this virus subtype.

The new test, called the AVantage A/H5N1 Flu Test, is made by Arbor Vita Corp., in Sunnyvale, Calif. In clinical studies, the test correctly identified the absence of infection in more than 700 specimens. It also correctly detected the presence of influenza A/H5N1 virus subtype in 24 cultured specimens from infected patients, the FDA said Tuesday.

"This test is an important tool to help quickly identify emerging influenza A/H5N1 infections and reduce exposure to large populations," Dr. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, said in an agency news release. "The clearance of this test represents a major step toward protecting the public from the threat of pandemic flu."