Fast-breaking News from AABB PulsePoints The following has been reproduced from the August 31, 2006 AABB PulsePoints, an electronic news alert provided by the American Association of Blood Banks.

August 31, 2006
No. 748

FDA Notification on Donor Referral Services Tissue Recall

AABB PulsePoints

The Food and Drug Administration (FDA) has issued a public health notification informing the health care community of the potential risk of human tissue recovered by Donor Referral Services (DRS). The notification states that the FDA and Centers for Disease Control and Prevention strongly recommend that health care providers that received tissue initially recovered by DRS inform their patients that they may have received tissue from donors for whom adequate donor eligibility determinations were not performed and offer them access to appropriate infectious disease testing. DRS is currently under investigation by the FDA for failing to follow federal regulations for tissue donor screening and testing.

Those firms that distributed tissue initially recovered by DRS - Alamo Tissue Services of San Antonio; Lost Mountain Tissue Bank of Kennesaw, Ga.; TissueNet of Orlando, Fla.; and US Tissue and Cell (USTC) of Cincinnati - have conducted recalls of all tissue remaining in inventory and continue to work with FDA to notify health care facilities that received this tissue so that health care providers of all patients who received the products can inform these patients and offer them access to testing. Health care providers who still have concerns or questions about the source of their patients' tissue implants should contact the health care facilities where the procedures were performed.

The notification indicates that no adverse reactions associated with these tissues have been reported and that subsequent processing is expected to reduce the potential risk of infectious disease transmission. Patients and health care providers are urged to report any adverse reactions that may be related to a tissue transplant to the appropriate processing and/or distributing firms. The notice also reminds establishments about the requirement to investigate any adverse reaction involving a communicable disease for which there is a reasonable possibility that the transplanted tissue distributed by them caused the reaction and to report fatalities and/or serious injuries to FDA.

To view a copy of the public health notification, visit www.fda.gov/cber/safety/drs083006.htm.