- The Washington Times - Friday, February 7, 2003

WASHINGTON, Feb. 7 (UPI) — The Food and Drug Administration said Friday that it is investigating whether the death of a patient following a blood transfusion is related to units of blood contaminated with white particles that were first reported in Georgia last week.

There are no indications the blood poses a health risk to patients, but the FDA is investigating the death and a handful of other adverse events reported in patients who received blood transfusions, Jesse Goodman, director of FDA's center for biologics evaluation and research, said during a teleconference. All the patients received transfusions of blood that were contained in the brand of bags involved in the original reports of contaminated blood. It is unclear whether the transfused blood contained the suspicious white particles.

Goodman noted that the patient who died had other health problems, and preliminary indications are the death was a result of heart or lung problems. In addition, there is no evidence the blood used contained white particles and the death "is not outside the spectrum of what occurs in severely ill patients," he said.

Goodman declined to give further details about the case due to confidentiality concerns.

The FDA advised patients to get blood transfusions if they need them because the benefits outweigh the risks. "FDA has no indication of a heightened risk of adverse events associated with blood transfusions at this time," the agency said in a written statement.

The FDA received reports beginning last week that 120 units of blood distributed to Georgia and several surrounding states, including Florida and Tennessee, contained white particulate matter that has yet to be identified.

Baxter Healthcare Corp. in Deerfield, Ill., the manufacturer of the bags in which the suspicious blood was found, has said its investigation indicated that the white particles were clumps of normal blood cells or proteins.

Even if the particles are normal blood proteins, it could still raise concerns because they may "encourage clotting or other phenomena in the blood," Goodman said. But he noted that there are "safety measures in place to deal with this," such as filtration of blood that "would tend to minimize potential risks."

The company is continuing to investigate the situation. "We have received and are analyzing additional samples from the Red Cross to identify the (blood) components," spokeswoman Tanya Tyska told United Press International.

Although the FBI initially had concerns about bioterrorism, tests conducted by the Centers for Disease Control and Prevention ruled out that theory because they indicated the particles were not infectious agents.

The FDA, CDC and the American Red Cross are conducting further tests to determine whether there are any safety risks posed by the blood. It is not known when the final results will be available, CDC spokesman Dave Daigle told UPI.

Several hospitals have quarantined blood while they await results of the investigation, and this has caused delays in surgeries. Some hospitals are warning that the blood shortage caused by the quarantine could cause a health crisis if they do not begin seeing an increase in blood donors.

Goodman also noted that the FDA has begun receiving additional reports of particulates found in blood in other blood banks and different bag types. However, he noted it was uncertain whether these were all related to the originally reported contaminated blood. Some of the additional reports may simply be due to increased scrutiny, he said.

Also on Friday, the FDA advised blood banks to begin visually inspecting blood and report any unusual findings to the agency. "The steps being taken are precautionary measures while the investigation continues," Goodman said.

Most blood banks already visually screen the blood they collect, Candice Gulden, spokeswoman for the Red Cross's Blood Services Southern Region in Atlanta, told UPI. "We inspect it visually, and that's how we originally saw this," Gulden said.

The visual inspection procedure should involve "placing the bag, label down, on a flat counter undisturbed for 10 minutes and then performing a visual examination for particles," the FDA said. The agency noted that the American Red Cross implemented these measures immediately after the tainted blood was first reported.

Goodman said the visual inspection procedure being advised by the FDA might help blood banks detect particles that may not be immediately obvious. "Some of these particles may not be easily visible under standard visual inspection and this is why we're recommending allowing the blood to set for a period of time before visualization," he said.

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(Dee Ann Divis, UPI Science and Technology Editor, contributed to this report.)

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