Beginning in May 2005, cord blood banks must meet new federal safety standards mandated by the Food and Drug Administration (FDA). Since 1997, Cord Blood Registry (CBR), the nation's leading newborn stem cell bank, has been preparing for these new regulations, which will set the baseline standards for all cord blood banks.
The blood remaining in the umbilical cord after it has been clamped and cut, "cord blood," has proven to be a rich source of stem cells, and a growing number of expectant parents are taking advantage of this once-in-a-lifetime chance by arranging to collect and bank their newborns' stem cells as a type of "biological insurance" to help protect their families' future health.
"Unlike other companies, we have been anxious for the FDA to issue these regulations," said Stephen Grant, Vice President of Communications for CBR. "CBR has spent a great deal of time and effort working with the FDA. Although CBR has always maintained the highest level of quality standards, these regulations provide an important legal foundation and add validation to the importance of family banking."
First proposed in 1997, the FDA rules require cord blood banks to take specific steps to prevent contamination throughout the collection, processing, labeling, and distribution aspects of the service. The only current industry oversight is offered by the AABB (formerly the American Association of Blood Banks), which established voluntary accreditation guidelines for cord blood banks. Leading the industry, CBR also worked with the AABB and became the first family cord blood bank to achieve accreditation in 1998.