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Statement of the American Red Cross Concerning Blood Quarantine

WASHINGTON, February 3, 2003 — As a result of an ongoing investigation regarding the blood supply in Atlanta, the American Red Cross has found white particulate in blood bags collected in its Tennessee Valley Region, based in Nashville. The discovery led Tennessee Valley to quarantine 70 percent of its blood inventory late Sunday.

Hospitals in both regions have quarantined blood collected in those regions. All of the affected blood was collected in the same type of blood collection bag. The Red Cross has quickly moved to bring in new blood bags in the affected regions to allow for increased collections.

We have asked our regions nationwide to inspect inventories for this particulate matter and report any such findings immediately.

To date, 110 units in the Southern Region and 10 units in the Tennessee Valley Region have been found to have white particulate. Through its national distribution system, the Red Cross has shipped 2,600 units to Atlanta this weekend and is expecting to send another 1,600-2,000 units today to help ensure blood availability. Tennessee has received 99 units and is expecting to import 400 by day’s end.

Extensive testing by the Red Cross, Centers for Disease Control and Prevention (CDC), the blood bag manufacturer and others has determined the white particles are non-infectious. CDC testing found no evidence the white matter is associated with any viral or bacterial biothreat agents including Ebola, anthrax, plague or smallpox. The CDC and others are continuing investigations into the nature of the white particulate. The Red Cross has received no reports of adverse patient reactions that can be tied to this issue.

The top priority of the American Red Cross is the safety and availability of the blood supply and the patients who rely on us to provide lifesaving blood. The quarantine of these units from hospital inventories is a precautionary measure taken to help ensure patient safety.

At this time, donating blood now is even more important. The Red Cross is asking eligible donors to schedule an appointment to donate blood by calling 1-800-GIVE-LIFE to help support their friends and neighbors across the country.

The Tennessee Valley Region covers middle Tennessee and parts of Illinois, Kentucky and Missouri. The Southern Region covers Georgia and part of northern Florida.

For more information, please contact: Michelle Hudgins at 703-312-5643 or Christine Pearson 703-312-5713.


Blood bag supplier: Specks are 'blood-derived'

Red Cross wants nationwide inspection for white particles

CNN By Debra Goldschmidt

Monday, February 3, 2003 Posted: 8:11 PM EST (0111 GMT)


WASHINGTON (CNN) -- The company whose containers are the suspected origin of white particles found in donated blood said Monday that its preliminary tests indicate the specks are "blood-derived in nature, likely a very small fibrin clot containing white blood cells and platelets."

Hours earlier, the Red Cross had asked its regions throughout the country to inspect their supplies of donated blood for signs of the white specks, which had been found in two Southeast regions.

In a written statement issued Monday afternoon, Baxter International Inc. said the particles are natural components of blood "which occur to varying degrees in stored blood under normal conditions."

The American Red Cross said it suspected the Baxter bags were causing the problem because the specks were not found in any other type of container.

Mary Malarkey, director of the Food and Drug Administration's case management division, said the FDA is "actively investigating the case," deploying people to investigate "all points involved." She said investigators will study the manufacturing and handling of the containers, and even weather conditions in the Southeast.

She said it was too soon to draw conclusions and added that the agency has not ruled out anything.

White specks were first found last week in bags of donated blood in the region covering Georgia and northern Florida. The problem appeared limited to about 4,000 bags manufactured by Baxter.

More particles were discovered Sunday in the Tennessee Valley Region. The Red Cross ordered the region, which covers middle Tennessee and parts of Illinois, Kentucky and Missouri, to quarantine 70 percent of its blood supply after the specks were found in 10 bags manufactured by Baxter.

Regional spokeswoman Patricia Smith said the substance in the blood is easy to see and "looks like granulated sugar of different sizes."

No problems have been found with blood in bags made by other manufacturers, Smith said.

The Centers for Disease Control and Prevention said the Georgia blood tested negative for infectious agents. Tests for non-biological material are under way.

A Baxter spokeswoman said Friday that after an investigation of samples received from the Red Cross, "we believe that all Baxter blood pack units are safe for use." She said the company was still collecting information.

The Red Cross has said it believes the contamination will be traced to the bags.

So far there have been no reports of adverse reactions from the contaminated blood, but Smith said it is not known whether any patients received that blood.

Hospital predicts 'dire straits' soon

There have been no reports of surgeries in Tennessee being canceled because of the quarantine. Blood is being imported to replace the quarantined units. Ninety-nine units were received from Detroit, Michigan, on Sunday, and three more shipments from Illinois, Maine and Wisconsin were scheduled to arrive Monday. Donation hours in the area have been extended through Wednesday.

Dr. Ann Neff, director of transfusion services at Vanderbilt Medical Center in Nashville, Tennessee, said Monday that the hospital is able to run its regular schedule, but it goes through blood quickly and could be in "dire straits as early as tomorrow."

Neff said she is "hopeful if not confident that we'll be fine" and said the Red Cross had filled the hospital's blood order. She said patients who donated blood for use during their own surgery or those whose family members donated blood for them are affected by the quarantine if the blood was collected in Baxter bags.

"They all have the option of getting blood from the donor supply, or, if their surgery is elective, they can decide to reschedule," she said.

The Red Cross Blood Services Southern Region reported a 25 percent increase in donations during the weekend after hospitals in Georgia were urged not to use the contaminated blood Thursday and many elective surgeries were canceled. That region received 2,600 units of blood from across the country last weekend, according to Marcy Blount in the Southern Region office.


Information Alert on Particulate Matter in Blood Bags

The American Red Cross (ARC) has reported finding multiple units of blood and blood components that contain white particulate matter in a small percentage of blood bags manufactured by Baxter Healthcare Corporation. The exact nature of the material is not yet known, though preliminary reports to FDA indicate that some particles are consistent with platelet clumps. While this problem has been reported primarily in multiple lots of Baxter blood collection bags with a sampling port (PL-146), FDA has received additional preliminary reports involving other types and other manufacturers’ blood bags and cannot rule out the possibility of similar findings with other bags. It is unclear at this time whether all reported observations are identical, whether all represent definite abnormalities, or whether there have been any resulting adverse health events due to the affected blood.

FDA has received a small number of adverse event reports in patients who received transfusions utilizing such bags, including one fatality that occurred in a severely ill patient. It is not yet clear whether the events are related to or unrelated to the possible presence of particulates. These reports are under investigation. Adverse events in the transfusion setting can occur for many reasons, including reasons related to and unrelated to the transfusion. FDA has no indications of a heightened risk of adverse events related to transfusions at this time.

ARC has implemented additional and specialized visual inspection procedures for examining liquid blood components for particulate matter. The procedures are performed prior to leukoreduction and at the time of packing for distribution. They include placing the bag, label down, on a flat counter undisturbed for 10 minutes and then performing a visual examination for particles.

FDA’s regulations already call for visual inspection of blood and blood components (21 CFR 606.160(b)(3)(ii), 640.5(e)). Because of this recent event, we are reminding blood establishments of the need to have and follow appropriate visual inspection procedures for all blood and blood components. At this time, while evidence is limited, FDA considers the procedures mentioned above to be appropriate as an interim precautionary measure. FDA plans to issue guidance to blood establishments (including hospitals and clinics) shortly on these and any other appropriate visual inspection procedures.

If a blood establishment detects particles in blood or blood components, it should quarantine the affected products. You may report your findings expeditiously to FDA at the following e-mail address:, or by phone at 800-835-4709. FDA also will monitor this e-mail address and phone number for reports of adverse events potentially related to the presence of particulate matter.

FDA and CDC are continuing in-depth investigations. These investigations include examination of both blood bag manufacturing and blood banking practices as well as testing of these products.

FDA is issuing this alert and is planning guidance as a precautionary measure. For patients who need blood, the benefits of transfusion continue to outweigh the risks. The Agency will continue to update the blood industry and the public as additional information becomes available. FDA will take additional actions as needed based on evolving information to protect the safety of the blood supply.

Blood donors serve an important public health role in our country. Blood donation is a safe procedure and continued donations are critical to maintaining a safe and adequate blood supply


Update on Particulate Matter in Blood Bags

The FDA previously commented on particulate matter observed in blood bags. This notice updates that February 7, 2003, statement.

Early this year, the American Red Cross (ARC) reported finding multiple units of blood and blood components that contained white particulate matter in a small percentage of blood bags manufactured by Baxter Healthcare Corporation (Baxter) and identified in the ARC Southern region. Subsequent reports revealed that this phenomenon also affected blood and blood components collected in bags made by other companies, and collected by ARC and non-ARC establishments in other areas of the country. Based on conditions under which the initial observations were made, FDA commented that it would be an appropriate interim measure to inspect blood bags visually prior to leukofiltration, at the time of packing for distribution, and after placing the bags, label down, on a flat counter, undisturbed for 10 minutes. Studies performed to date have failed to show any increase in adverse events, any correlation of adverse events with presence of particulates, or any anomalies in the manufacture of blood bags that could have caused an increase in formation of particulates. Therefore, FDA currently believes there is no additional value provided by the enhanced visual inspection.

Numerous investigations by Baxter and other blood bag manufacturers, FDA, NIH, CDC and ARC focused on the nature of the particles and the possible cause of their formation. Physical characterization of the particles themselves revealed them to be composed of normal blood elements (aggregates of platelets, with variable amounts of fibrin and trapped red and white cells) and not of extraneous material or organisms. The formation of similar aggregates has been well reported in previously published literature. In addition, unintended changes in the composition of the blood bags themselves and their contents, which might have contributed to an increase in particle formation, could not be demonstrated. (Certain changes related to storage of the blood bags remain under study.) The frequency of formation of visually detectable particulates was correlated with absence of leukocyte reduction and with the use of higher g-forces in centrifugation to make components. Leukocyte filtration was demonstrated to remove most observable particulates.

Epidemiological investigations by the Georgia Department of Public Health in conjunction with CDC and blood centers that may have received affected products addressed the question whether any change had occurred in the frequency of adverse events from transfusion over the 12 months prior to and including the time period associated with recognition of unusual particulates in blood components. In addition, two blood centers prospectively collected data on the frequency of adverse events associated with leukofiltered and non-leukofiltered units, and any correlation with presence of particulates. No increase in adverse events was seen either as a general national trend or in specific hospitals and blood centers that made efforts to identify adverse reactions that might have been associated with particulates in released units. Although these studies found no evidence for an increase in the frequency of adverse events from transfusion associated with the recent observations of particulates, and units with particulates were not associated with more frequent adverse events than those without, the available data cannot conclusively rule out a potential association between particulate formation in blood units and some adverse events included in historical background rates. FDA therefore remains interested in the investigation of formation of particulates in blood units and their potential relevance to transfusion safety.

FDA’s regulations call for visual inspection of blood and blood components during storage and immediately prior to distribution and issuance (21 CFR 606.160(b)(3)(ii), 640.5(e)). Pending investigations into the original reports of unusual findings of particulate matter in blood units, FDA considered the additional procedures mentioned above to be appropriate as an interim precautionary measure. Along with this inspection, blood establishments were encouraged to report observations of these particles in blood or blood components, quarantine the affected products and report findings expeditiously to FDA at the following e-mail address: or by phone at 800-835-4709. Based on the studies summarized above, FDA currently believes that there is no additional value provided by the enhanced visual inspection, and therefore it would be appropriate for blood establishments to discontinue that procedure. However, because the data cannot conclusively rule out a potential association between particulate formation in blood units and some adverse events, it may be appropriate for blood establishments to consider the use of leukocyte reduction as a measure to reduce the frequency of particulates in released units.





Posted  1.05.05 1:04am

Revised 1.05.05 1:04am




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