Red Cross Fined over Blood Collection Violations; What Does It Mean for Orthopedics?
BY LAUREN UZDIENSKI, SEPTEMBER 13, 2006
As the Wall Street Journal (subscription required) reported this week, the American Red Cross will be fined $4.2 million for failing to honor federal blood-collection regulations.
More than 12,000 units of blood were recalled during 2002 and 2005, and these recalls were deemed by the FDA to be "preventable." They occurred due to the Red Cross' failure to question donors appropriately, follow manufacturer test protocols and screen for infection. Prior to this latest ruling, the Red Cross had been fined $5.7 million for violating blood-safety codes in previous years. This news follows a recent scandal regarding safe use of allograft, when the FDA recalled tissues based on similarly inadequate donor screening processes.
For orthopedics, the question of blood safety is particularly relevant: elective orthopedic surgery has one of the highest rates of patient blood loss. An unsafe blood supply is a threat to both surgeons and patients.
Some companies are seeking a solution in synethic blood. Biopure Corp., devoted to the development of oxygen therapeutics, is one of the companies working on an alternative to donor blood. Biopure manufactures Hemopure, a blood substitute, which is in the trial phase in the U.S. Internationally, it has undergone clinical trials for an orthopedic indication. The combination of high-volume blood loss and routine procedures have made the specialty a valuable testing ground, and Biopure is currently pursuing authorization to market the blood substitute in the U.K. for use in orthopedic surgery. Hemopure is already available for sale in South Africa.
The treatment is controversial. Derived from cow's blood, Hemopure's benefits are numerous: the blood is oxygen-carrying, eliminates the need for donor matching, has a longer shelf life than donor blood, and reduces the risk of hepatitis or HIV infection (the threat of infection, particularly in light of past and current fines, looms over the Red Cross blood supply.)
However, blood substitutes are no ideal alternative. Results from Hemopure's previous clinical trials have shown increased risk of hypertension, stroke, and heart attacks when compared to patients receiving donor blood.
Biopure insists its product is safe, but the road to the O.R. won't be an easy one: several FDA meetings regarding the product have been postponed. With a Red Cross safety breach on one hand, and a problematic synthetic on the other, the question of avoiding patient blood loss has no simple answer.
