Stricter FDA Blood Bank Control Led to More Error Reports
"[E]rror and accident" reports from blood banks and plasma centers "jumped" 51% last year after the FDA implemented new restrictions to decrease risk of transmitting Creutzfeldt-Jakob disease, the human variant of mad cow disease, the Wall Street Journal reports. Last spring, the FDA adopted the new rule, which bars blood donations from individuals who spent six months or more in Great Britain between 1980 and 1996. The regulation also requires blood banks and plasma centers to check their records to see if ineligible donors have given blood or plasma in the past and mandates that centers destroy the previously donated blood or plasma and file an error report to the FDA. During the fiscal year that ended last September, blood banks, plasma centers and makers of blood-derived products filed 23,528 error and accident reports, compared with 15,532 reports filed the previous fiscal year. The Journal reports that some of the increase could be attributed to "stepped up" reporting by blood-collection agencies. For its part, the FDA said that the rising number of error reports "doesn't mean blood and blood products are less safe," adding that transmission of the disease through blood is "only 'theoretical.'" An FDA spokesperson said that the agency adopted the ban as a "cautionary measure." The FDA is not requiring blood banks to notify individuals who received blood from an ineligible donor. About 100 people across Europe have died of Creutzfeldt-Jakob disease (Carroll, Wall Street Journal, 6/4). To read the FDA's summary of error and accident reports, go to http://www.fda.gov/cber/error/eafy00.pdf.This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.