FDA order will lower U.S. blood reserves
Apheresis technology may provide solution
The U.S. Food and Drug Administration (FDA) and Health Canada have directed blood collection agencies in their countries not to collect blood from anyone who has visited the United Kingdom for an extended period of time since 1980. This could reduce by as much as 2.2%, or 286,000 units, the amount of blood donated in the United States each year.
Last May, the National Blood Data Resource Center (NBDRC), predicted that the United States’ need for blood would exceed its supply by 249,000 units next year. The two factors combined may create a blood shortage of more than 500,000 units, which could affect as many as 400 patients nationwide.
The FDA mandate states that blood centers must defer blood donations from any person who has visited or resided in the United Kingdom for a cumulative period of six months or more since 1980 in order to reduce the theoretical risk of transmitting new variant Creutzfeldt-Jakob disease (CJD), a derivative of mad cow disease, through blood transfusion. CJD is an infectious, rapidly progressive, fatal brain-deteriorating disease. Researchers in a Yale University study found 13% of Alzheimer patients upon autopsy really had CJD.1 (You may read the blood labeling text in full at the FDA’s Web site: www.fda.gov/cber/gdlns/ cjdnvcjd.txt.)
Technology from Braintree, MA-based Haemonetics Corp. allows blood centers to safely collect twice as many red blood cells from one donor as they can collect with traditional manual techniques has received FDA approval. This technique, known as apheresis, was pioneered by Haemonetics in the 1970s for collecting platelets and then plasma. What is new is the ability to use apheresis to collect red blood cells, the most frequently needed blood component. More than 40 million red cell units are transfused annually worldwide.
Apheresis is an automated blood collection technique using a closed circuit disposable collection system. Donated blood is centrifuged immediately into its component parts (platelets, plasma, and red cells) allowing one or more transfusable doses of the desired component(s) to be separated into blood collection bags. The unused portion of the blood is then returned to the donor. Unlike traditional manual collection processes, the blood collected through apheresis requires no further processing before transfusion to a patient, making the procedure efficient and cost-effective for blood centers.
The below chart illustrates the impact that implementing apheresis blood donor programs can have on the blood supply:
| Apheresis Donations Needed | Manual Blood Donations Needed | |
| Yield for Patient | ||
| 2 doses of platelets | 1 | 12 to 20 |
| 1 dose of platelets | 1 | 6 to 10 |
| 1 dose of platelets and 1 of plasma | 1 | 8 to 12 |
| 2 doses of red cells | 1 | 2 |
According to Harvey Klein, MD, chief of transfusion medicine at the National Institutes of Health, "Mandates such as this are intended to assure a safe blood supply, but they often reduce blood availability which creates different patient risks. By using apheresis technology for the collection of red cells, blood centers could significantly increase the number of red cell units collected from their existing donor base."
Haemonetics will bring blood donation by apheresis to the donor on mobile drives, where 70% of the U.S. blood supply is collected. Haemonetics is a global company that designs, manufactures, and markets automated blood processing systems. Those systems address important medical markets: surgical blood salvage, blood component collections, and plasma collections. More than 60% of the company’s business is outside the United States. For more information, call Haemonetics at (781) 356-9517, or visit its Web site at www.haemonetics.com.
Reference
1. Manuelidis E, Manuelidis, L. Suggested links between different types of dementias: Creutzfeldt-Jakob Disease, Alzheimer Disease, and retroviral CNS infections. Alzheimer Dis and Assoc Disord 1989; 3:100-109.
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