Red Cross Statement Regarding Costa Mesa Tissue Processing Facility

Statement for response to media query:

WASHINGTON, Thursday, April 01, 2004 — The American Red Cross has informed the U.S. Food and Drug Administration (FDA) that effective March 19, 2004 at 5:00 pm (PST), the Red Cross Costa Mesa facility voluntarily suspended distribution of allograft skin and cardiovascular tissue.

In October and November 2003, the FDA inspected the facility and subsequently issued a Form FDA-483, which contained observations regarding Red Cross quality systems design for heart valves and validation of certain procedures related to allograft skin. The quality systems design issues relate to the manner in which heart valves are regulated – as medical devices rather than as human tissue. In March 2004, the FDA issued a “Warning Letter” to the facility based on the same inspection. The FDA’s action was not linked to the amended Consent Decree because Tissue Services is not covered by the decree. It is important to note that the FDA observations were not related to any issues of adverse events and no recall of tissue was required. Tissue that has been distributed and is in inventory is not part of this voluntary suspension and can be transplanted.

The Red Cross has begun to implement corrective actions and is seeking to engage the services of an independent third party to evaluate the facility’s compliance status. Once the Red Cross is satisfied that the FDA’s concerns have been resolved, we will resume processing and distribution of cardiovascular tissue and allograft skin. While this voluntary suspension is in effect, we are working to secure an alternative manufacturer for these products. This suspension does not affect any other services or tissues, including allograft bone.

The American Red Cross is dedicated to helping make families and communities safer at home and around the world. Governed by volunteers and supported by community donations, the American Red Cross is a nationwide network of more than 900 chapters and Blood Services regions dedicated to saving lives and helping people prevent, prepare for and respond to emergencies. Led by 1.2 million volunteers and 32,000 employees, the Red Cross annually mobilizes relief to families affected by more than 67,000 disasters, trains almost 12 million people in lifesaving skills and exchanges more than a million emergency messages for U.S. military service personnel and their families. The Red Cross is the largest supplier of blood and blood products to more than 3,000 hospitals across the nation and also assists victims of international disasters and conflicts at locations worldwide.

Contact:
Media who have additional questions should call Ryland Dodge at (202) 303-5492 or Michelle Hudgins at (202) 303-5643 in Red Cross Biomedical Communications.