|
|
|
FDA Home Page | Search
FDA Site | FDA A-Z Index | Contact
FDA
| Email
this Page To a Friend |
 |
FDA Consumer
magazine
July-August 2003 Issue
By Carol Rados
The American Red Cross has agreed to tighten its procedures and processes for the manufacture of blood products as part of an amended consent decree with the Food and Drug Administration. If the Red Cross fails to comply with blood safety rules and other requirements, heavy fines can be imposed.
The amended decree, signed by the organization and the FDA in April, follows 17 years of serious and persistent violations of blood safety rules. In a prepared statement, the Red Cross said that previously debated issues between it and the FDA have been resolved and that the amended consent decree marks "a new era of cooperation."
"I am hopeful that the acceptance of this agreement by the American Red Cross' new leadership reflects a new willingness to implement a management culture that expects and achieves good blood safety practices," says FDA Commissioner Mark B. McClellan, M.D., Ph.D.
As part of the amended decree, the Red Cross agreed to upgrade its blood collection program to comply with government standards aimed at ensuring blood safety. The agreement was struck after years of negotiations failed and the FDA filed a motion to hold the Red Cross in civil contempt.
The Red Cross is responsible for 45 percent of the nation's blood supply. Independent and community blood facilities contribute another 45 percent to the pool, and hospitals contribute 10 percent.
In the original 1993 consent decree, the Red Cross had agreed to establish clear lines of managerial control over a newly established quality assurance system in all regions, to enhance training programs, and to improve computer systems, records management, and policies for investigating and reporting problems.
Since 1993, a number of safety problems were identified by FDA inspections. In an inspection at Red Cross biomedical headquarters in Arlington, Va., in 2000, the FDA found that the Red Cross was unable to track blood products well enough to enable expedient recalls, was not maintaining an accurate record of deferred donors, and was not labeling blood components correctly. An inspection in 2002 found continuing issues with quality assurance, donor deferral, product labeling, traceability of blood components, and investigation of donors implicated in post-transfusion infections.
The amended decree includes many of the provisions contained in the 1993 consent decree. However, in addition to heavy financial penalties, the updated document provides a series of deadlines for completing requirements of the decree, and it addresses additional violations observed since 1993.
"The new financial penalties in the consent decree create an important new incentive for the American Red Cross to improve the processes and controls necessary for making safer blood products," says McClellan.
Over the years, the FDA has strengthened the safeguards that protect patients from unsuitable blood and blood products. Blood donors, for example, are now asked specific and direct questions about risk factors that could indicate possible infection with a transmissible disease. This "up-front" screening eliminates about 90 percent of unsuitable (deferred) donors. The FDA also requires blood centers to maintain lists of unsuitable donors to prevent the use of their blood. In addition, blood donations now are tested for six infectious agents.
Concurrently with the strengthening of safeguards, the FDA has significantly stepped up its oversight of the entire blood industry. On-site inspections are conducted at least every two years. If problems are found at any blood establishment, appropriate regulatory or legal actions are taken, and inspections of that facility are done more often to ensure compliance with regulations.
The Red Cross has agreed to retain outside consultants to evaluate aspects of its quality assurance program and to reimburse the FDA for costs associated with inspections the agency considers necessary to evaluate the organization's compliance with the amended decree.
When the agreement was announced in April, McClellan said he would like to see "management changes that create an environment where the kinds of specific problems seen over the last 17 years are less likely to happen." Marsha Johnson Evans, Red Cross president and chief executive officer since August 2002, has promised to restore the public's trust in the organization