Allograft Industry Faces Another Donor Scandal
BY ARIELLA P. GOLOMB, MD, AUGUST 28, 2006
Donor Referral Services of North Carolina is at the center of a new scandal surrounding donor tissue and was shut down by the FDA on August 18, 2006. The order forced the facility to cease manufacturing and to retain Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps). The FDA cited serious deficiencies in accurate record keeping, manufacturing SOPs and record screening.
However, Allosource did not wait for the FDA's intervention to start their own recall of Donor Referral Services sourced tissues, recalling around 300 donor parts on July 6, 2006. In response, other allograft companies, such as Osteotech and Tutogen have come out in public, clearing their name of the scandal by stating that they have not conducted business with Donor Referral Services. While these companies may disassociate themselves from this recent news, last fall's Biomedical Tissue Services Ltd (BTS) scandal coupled with this recent news will weigh heavily on physicians' comfort with using cadaveric tissue. This is significant for the orthopedics industry because allograft is routinely used in orthopedic procedures and offers benefits over autograft (donor site morbidity and supply), synthetic (efficacy) and xengoraft (disease transmission, i.e. prions) tissue sources.
It is worth noting that both Donor Referral Services and Biomedical Tissue Services Ltd (BTS) are not on the American Association of Tissue Bank's Accredited Tissue Bank List.
Stay tuned for our research report on the Allograft industry, by Jeff Sandler, to be published this fall.
