The Food and Drug Administration likely will delay mandating the removal of white cells from blood for transfusion, following a public meeting held earlier this month to discuss the change.
Concerns about cost, a short supply of specialized filters and the challenge of implementing the labor-intensive process at blood banks across the country will slow, though not stop, the nationwide switch to blood depleted of white cells.
Some observers had anticipated that the FDA would mandate the change by year-end. The agency is working on instructions for implementing the policy, which will likely be released next year as a "guidance" document to the industry, an FDA spokeswoman said. The actual switch is expected to take effect in about two years, she said.
Routine removal of white cells from blood, called leukoreduction, promises to eliminate certain transfusion side effects and shorten hospital lengths of stay, advocates say.
There are no clinical drawbacks to leukoreduction. But some doubters insist its purported benefits, greatest for certain vulnerable patients, do not yet warrant the costly filtration of the entire supply of red blood cells and platelets (Nov. 29, p. 8).
By some estimates leukoreduction could add $500 million to the $2 billion-plus that hospitals spend on blood each year.