Transmatter Control Agent (reference)
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
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
http://www.fda.gov/cber/infosheets/alertprtbld.htm
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:
BP_Deviations@cber.fda.gov,
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
http://www.fda.gov/cber/infosheets/bldpartic.htm
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:
BP_Deviations@cber.fda.gov
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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