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Organ Recall

In an effort to limit the potential for recall of organs used for transplantation, the Food and Drug Administration has taken several approaches to ensure safety. These include donor suitability, appropriate testing, proper processing and shipping of materials and the monioring of adverse events.

The FDA's Center for Biologics Evaluation and Research (CBER) is responsible for regulating many different types of human tissue and cells transplanted during various types of medical procedures. CBER's role in any organ recall may be somewhat limited.

The FDA uses education, training and appropriate regulation to help reduce the risk of an organ recall. Reasons for an organ recall include the possibility of the spread of communicable diseases. By issuing an organ recall it is hoped the public's confidence in the safety of the procedures will be enhanced.

During the 1980s and 1990s several incidents of the transmission of infectious diseases spurred the agency to take a look at its role in organ recall.These incidents include:

• Reports of multiple incidents of transmission of the degenerative neurologic disorder, Creutzfeld-Jakob Disease (CJD)
• A 1992 report that seven people were infected with HIV through transplantation of organs and tissue from a single donor.
• Possible transmission of CJD through corneas and eye tissue
• Three confirmed organ recipients and six probable tissue recipients who were determined to be infected by hepatitis C from a single donor’s tissues.

These risks may relate to how the tissue is handled, processed and tested and not in the donor.

The overall risk of disease transmission through tissue transplantation, which could result in an organ recall, is believed to be very low. However, more tissue transplants are taking place each year and the FDA is taking steps to better understand, detect, prevent and act upon threats to tissue safety which could necessitate an organ recall. Anyone receiving a recall notice is encouraged to contact an experienced law firm .

In December 1993, the FDA published an interim rule for Human Tissue Intended for Transplantation (21 CFR Part 1270), which provided specific donor suitability and testing requirements for human tissues. FDA acted to counter the transmission of three serious disease agents: HIV, hepatitis B and hepatitis C. This rule also provided for the inspection of tissue banks and the recall and possible destruction of unsafe human tissue. When the final rule was published on July 29, 1997, a guidance document on donor screening and testing was published to accompany and update the rule.

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