The testing errors involved dilution and sample handling, and included equipment failures that posed a remote possibility of adverse health consequences. The following can be used to answer questions. FDA is responsible for regulating the blood industry and for determining that blood products are safe and effective. The monitoring includes at least one annual inspection of each of the more than 2,400 U.S. blood establishments. If an inspection reveals that the regulations are not being followed, FDA can order recall, issue warning letters or suspend or revoke operating licenses.
Legal actions can result in civil or criminal penalties, including seizure of the product.
The heart of the safety system established by the agency is five layers of overlapping safeguards that start at the blood collection center and extend to the manufacturers and distributors of the blood products. The first level of precautions seeks to eliminate risky donors by evaluating their medical history and encouraging self-exclusion by those whose blood may pose a health hazard. The second safeguard consists of testing the blood for such blood-borne agents as HIV, hepatitis and syphilis. The third entails constant updating of a list of unsuitable donors, and checking donors' names against the list. The fourth safeguard enforced by FDA is a quarantine of all donated blood until tests establish its safety.