As organ and tissue transplantation has become more viable and more commonly practiced, the demand for donor tissues and organs has increased. An industry of companies that harvest and provide tissues for transplant has surfaced to meet this demand. Almost any kind of tissue may be handled by this industry, including organs, skin, and bone. So how exactly is it that companies who provided this service were not required to register with the FDA until 2004?
It seems that prior to 2004 regulation of transplant tissues paled in comparison to that of the meat-packing industry. How is it possible that tissues that we eat and pass through our bodies are better screened than those that are placed permanently in our bodies? While my knowledge of the immune system is far from up to par, it seems to make biological sense that its easier for my immune system to fight off a population of bacteria originating from a food that passes through the digestive system, as there it will at least be partly processed and degraded, unlike a bacterially infected tissue that takes permanent home with other bodily organs and tissue.
New developments have surfaced since first beginning this writing in July 2006. Just this month, the FDA ordered the human tissue recovery firm Donor Referral Services (DRS) to shut down its operations, finding “serious deficiencies in its manufacturing practices, including those governing donor screening and record keeping.” I find this astounding. It seems that at every suspect outbreak of mad-cow disease, there is a barrage of public health warnings and media hype, quickly followed by indications that the disease path as been tracked and the origination determined and quickly shut down. Amazingly, records and manufacturing processes for tissue recovery and donation seem much looser. Case in point is the instigation of the shut down of DRS: “FDA's inspection identified serious violations of the regulations, including the failure to establish and maintain procedures for manufacturing steps...FDA also found several instances where records provided by DRS to another HCT/P establishment were at variance with the official death certificates FDA had obtained from the state where the death occurred.”
The FDA's new regulations for tissue recovery and transplant services took effect in May 2005. “Among other mandates, the regulations require firms to properly screen and test donors and, when needed, they enable FDA to take swift action in the interest of public health.” Better late than never I suppose; but I can't help but suspect that both the industry and the FDA is saving face for not implementing preemptive regulation long ago.
New regulations for donor eligibility and screening can be viewed here: http://www.fda.gov/bbs/topics/news/2004/NEW01070.html
Press release on DRS shutdown: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01433.html