Organ Recall

The Food and Drug Administration has taken several safety approaches to ensure in an effort to limit the potential for recall of organs used for transplantation. These are suitability of the donor, proper testing, appropriate processing and shipping of materials, along with the monitoring of any adverse events.

TheCenter for Biologics Evaluation and Research (CBER), part of the FDA, has the responsibility to regulate different types of human tissue and cells transplanted during various types of medical procedures. Though somewhat limited, CBER has a role in any organ recall.

Education, training and appropriate regulation is used by the FDA in an effort to reduce the risk of an organ recall. The possibility of the spread of communicable diseases is the main reasons for an organ recall. When an organ recall is issued, it is hoped the public's confidence in the safety of the procedures will be bolstered.

Several incidents of the transmission of infectious diseases during the past 20 years caused the agency to take a look at its role in organ recall.These include: reports of multiple incidents of transmission of the degenerative neurological disorder, Creutzfeld-Jakob Disease (CJD); a report of seven people being infected with HIV through organ transplants from a single donor; transmission of CJD through corneas and eye tissue; and three confirmed organ recipients infected by hepatitis C from a single donor.

CBER says these risks may relate to how the tissue is handled, processed and tested and not the donor.

The major risk of receiving a disease through tissue transplantation, which could result in an organ recall, is considered very low. However, since the number tissue and organ transplants is growing each year and although the FDA is taking steps to better prevent threats to tissue safety which could necessitate an organ recall, the possibility does exist, according to an attorney familiar with the issue.

An interim rule for Human Tissue Intended for Transplantation (21 CFR Part 1270) by the FDA provided specific donor suitability and testing requirements for human tissues. The rule is to counter the transmission of three serious diseases, including HIV, hepatitis B and hepatitis C.