FDA: Red Cross Blood Processing Flawed

W A SH I N G T O N, Dec. 2 -- A federal agency is questioning the handlingof blood supplies by the American Red Cross, saying the agencyrepeatedly failed inspections over 15 years and continues to haveproblems that could harm patients.

Documents filed in U.S. District Court by the Food and DrugAdministration said the Red Cross is not in compliance with thecurrent laws and regulations.

“The problems are serious because ofthe potential for harm,” FDA official Dr. Jay S. Epstein saidFriday.

The Red Cross collects about 6.5 million units of bloodannually, about half of the nation’s medical blood supply.

Long-Standing Violations Alleged

The FDA filings maintained the Red Cross has “along-standing and ongoing failure to comply with good manufacturingpractice” standards in collecting, processing and distributingblood used in medical procedures.

The Red Cross “has not been in compliance with the [standards] … since at least 1985,” the FDA said, saying increasingly toughactions by the government have failed to correct the problems.

Dr. Bernadine Healy, the American Red Cross president and chiefexecutive, said the blood supplied by the organization is “thesafest in the world.”

“We are not releasing dangerous blood, but there have been nearmisses,” she said. “These are red flags and we are jumping onthem.”

The FDA said the Red Cross failed inspections in 1985. Afterrepeated notifications of noncompliance, it entered into anagreement in 1988 to pursue a plan to meet agency standards.

The problems continued and the FDA sent three noticesthreatening to revoke establishment licenses. The license of oneRed Cross center eventually was revoked.

Failed Inspections

“When even these measures did not spur [the Red Cross] tomeaningful action, FDA negotiated” a 1993 court decree thatrequired better controls and a quality assurance program, courtpapers said. The FDA said that since 1993 it has sent 10 letterswarning the Red Cross of noncompliance with blood centerregulations.