FDA Issues New Rules to Protect Blood Supply

The Food and Drug Administration issued new proposals Thursday designed to further ensure the safety of the nation’s blood supply.

Saying blood banks must recognize that they are no longer simply providing a service but “are manufacturing a product,” the agency called for improvements in employee training, testing procedures, audits and other administrative functions to guard against the accidental release of blood products contaminated by infectious agents, such as the viruses that cause AIDS and hepatitis.

“We are committed to holding all blood centers to the highest standards” of production, “just as we would a manufacturer making a drug,” FDA Commissioner David A. Kessler said. “The emphasis should be on preventing problems rather than detecting them retrospectively.”

Kessler noted that multiple protections already exist to minimize the chances that contaminated blood will be used. And blood is already tested for the presence of the AIDS and hepatitis viruses, among others.

However, breakdowns have occurred occasionally in some parts of the system, he said. He attributed the problems to numerous factors, including the growing number of required tests--which increases the chance of error--the use of more complex technology and a shortage of appropriately trained personnel.

The proposed new procedures--which will become final after a public comment period--will serve only as guidelines for blood banks, although the FDA has the power to shut down agencies that do not meet quality standards.

In a key departure from past practices, the FDA will mandate “look back” procedures for tracking blood from donors who are later found to be infected with the AIDS virus.

Under the now-voluntary “look back” programs, when a repeat donor tests positive for the human immunodeficiency virus, blood centers retrieve and quarantine all of the blood that person has given previously, if it is still available.

The donor’s most recently donated blood is then subjected to a more accurate test--since “false positives” occur frequently. If the test is positive, all units of blood from that donor--past and present--are destroyed.

The centers also would be required to inform hospitals who have received the donor’s blood of the positive test results so that past recipients can be notified.