Report Faults Military's Blood Program
N E W Y O R K, March 14, 2001 -- Nearly half of the U.S. military's reserve of frozen blood, intended primarily to treat casualties in wartime, could soon be quarantined for being out of step with national standards.
In September, 48 percent of the military's frozen red blood cell supply will be older than the Food and Drug Administration's (FDA) requirement that frozen blood have a shelf life of just 10 years, according to an audit report by the Pentagon's inspector general's office.
The FDA recommends the quarantined blood only be used in emergencies.
Also, 26 percent of the military's overseas frozen inventory is currently similarly restricted because it has not been subjected to the most current FDA-required test for the HIV virus which causes AIDS, the report said. That blood was tested using a previously approved test, which military officials say is infinitesimally less accurate. Because of how that blood was frozen, the new test cannot be applied.
The inspector general's report says neither situation is ideal. "We believe that DoD (Department of Defense) should strive to have frozen blood inventory composed entirely of fully tested, non-expired red blood cell units."
Ready for War?
The issue of having an adequate reserved blood supply is a so-called military "readiness" issue. Critics for years have charged that U.S. military readiness has been on a decline, with not enough of the Pentagon's $300 billion budget spent on training, equipping, and supplying the troops.
Citing the potentially quarantined blood, the inspector general's report, released earlier this month, warned the military may not be ready for war: "DoD may not be able to effectively supply blood products to the blood program organizations and forward medical units in the event of a major theater war."
Responding to the report, the Armed Service Blood Program notes the FDA does allow the use of quarantined frozen blood cells in a contingency. So with frozen blood younger than 10 years and between 10 and 21 years available, the Blood Program says the military would be ready, according to the report.
Is the Blood Safe?
The Department of Defense has tried since 1996 to get the FDA-approved shelf life extended. But the FDA so far hasn't done so out of concern about the survival rate of red blood cells older than 10 years that are thawed and deglycerolized, according to the report. Glycerol is added to the cells prior to freezing, to prevent ice crystals from forming.
Air Force Maj. Ronny Alford, deputy director of the Armed Services Blood Program Office, says research by the Navy indicates blood can be kept up to 22 years. His program is asking the FDA to extend the approved storage life from 10 to 17 years.
A spokesperson for the FDA, who asked not to be named, said the agency has seen no evidence that the use of older frozen blood could be unreliable or harmful to use. But so far, it has yet to rule on any statistics showing frozen blood stored for more than 10 years could be used.
As for the added benefit of applying the new HIV test, Lynn Kukral, a spokeswoman for the Army's surgeon general, says it would be small.
The current test can detect the virus as early as 16 days after a person is infected. The previous test detected the virus 25 days or more after exposure.
"The FDA says the difference between the two tests is that the new test would detect an additional infected unit out of about 2.6 million," she says.
Rotate it Out?
But the military has no immediate plans to replace the older blood, and that not subjected to the latest HIV test, so none of its inventory would be restricted for contingencies.
"What would drive us to replace it based on age is if the FDA said, 'we don't agree with you,'" says Alford.
The Pentagon will continue to keep in inventory frozen units of blood older than 10 years, and blood not checked for HIV with the latest test, for contingencies.