FDA Issues Bulletin on Human Donor Tissue Recall
The Food and Drug Administration (FDA) has released a news bulletin to notify the public of its investigation of human tissue that was recovered and subsequently distributed to tissue processors.
Some of the donor tissue implanted into patients from early 2004 to September 2005 may not have met FDA donor eligibility requirements and may not have been properly screened for certain infectious diseases.
The following tissue processors received tissue from Biomedical Tissue Services, Ltd., of Fort Lee, New Jersey:
- LifeCell Corporation of Branchburg, New Jersey
- Lost Mountain Tissue Bank of Kennesaw, Georgia
- Blood and Tissue Center of Central Texas in Austin, Texas
- Tutogen Medical, Inc., of Alachua, Florida
- Regeneration Technologies, Inc., of Alachua, Florida
These firms have been working with the FDA and the Centers for Disease Control and Prevention (CDC) to notify physicians whose patients may be affected by this investigation and recall.
The FDA and the CDC are recommending that implanting physicians inform their patients that they may have received tissue from a donor for whom an adequate donor eligibility determination was not performed. While the overall infectious risk is likely low, the FDA and the CDC recommend that physicians offer to provide patients with access to appropriate testing.
We have learned that information may affect orthopedic surgeons, neurosurgeons, and dental surgeons who perform dental implants. We recommend that all physicians involved in this recall be proactive in offering full disclosure to their affected patients.
For additional information on the specifics of the investigation and recall, please read the FDA’s October 26, 2005, news bulletin, or contact them at (800) 835-4709.
The Doctors Company is committed to providing you with outstanding member services. If we can assist you, please call the Department of Patient Safety at (800) 421-2368, extension 1243.
