Health Headlines - April 10

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.

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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."

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U.S. Sets 2010 Medicare Advantage, Part D Drug Rates

The national average growth percentage per capita for Medicare Advantage plans will increase 0.8 percent in 2010, the U.S. Centers for Medicare & Medicaid has announced.

That's higher than the 0.5 percent increase in preliminary rates announced by the CMS in February, but much lower than the 4.24 percent and 5.71 percent increases this year and in 2008, the Associated Press reported.

The main reason for the large difference is a proposed 21 percent pay cut in physician reimbursement for 2010.

Despite the 0.5 percent increase in the rate used to determine Medicare Advantage reimbursement to insurers, many analysts expect overall payment rates to decline in 2010, the AP reported.

The CMS also announced that next year there will be an average 4.66 percent increase in average per capita Part D Prescription Drug Plan spending that's used to update the deductible, initial coverage limit, and out-of-pocket threshold for defined standard benefits.

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Pistachio Recall Expanded

A nationwide recall of pistachio products from a California plant has been significantly expanded after federal and state health officials found salmonella bacteria in "critical areas" of the Setton Pistachio facility, the Washington Post reports.

While investigators didn't provide any more details, the company has announced it's now recalling all lots of roasted in-shell pistachios, roasted shelled pistachios and raw shelled pistachios produced from nuts harvested in 2008, the newspaper reported.

Last week, Setton recalled about 2 million pounds, which represents just a small portion of the 2008 harvest. At the time, it was believed the pistachios may have been contaminated by a sanitation problem that affected only one or two production lines.

Setton is the second-largest pistachio processor in the United States and supplies about 35 wholesalers and food manufacturers that repackage the nuts for retail sale or use them as ingredients in other products, the Post reported. The U.S. Food and Drug Administration said it could take weeks before there's a complete list of affected products.

To help consumers, the pistachio industry created a Web site that lists products not affected by the recall. The Web site address is www.pistachiorecall.org.