Shortly before Christmas in 2009, surgeons performed an emergency operation to save a patient suffering from an aortic aneurysm. But soon afterward, a deadly infection struck, and septic shock set in. When that happens, blood pressure can plummet and the heart, kidneys, lungs and liver may fail. Such was the fate of the patient, who died that Christmas Eve.
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About biological products
Human tissue for transplant is used in the treatment of more than one million people a year in the United States.
Implants include heart valves for children with congenital defects, bone to replace tissue destroyed through injuries or infection, veins for patients who might otherwise lose limbs, and ligaments and tendons to repair sports injuries.
The U.S. Food and Drug Administration regulates tissue recovery, screening and testing of deceased donors, processing, packaging, storage and distribution to try to prevent the spread of communicable diseases. It relies on manufacturers to assess product complaints. For credible reports of deaths or injuries, or acombination of complaints, companies are supposed to undertake specific and serious efforts to understand the cause.
All tissue carries some risk of disease. Tissue implants themselves would have to be destroyed to be cultured in a way to be certain they are free from harmful microbes. Instead, they may be swabbed on the outside for testing. However, companion tissue from the donor may be cultured since it won’t be used, and blood samples from the donor are tested.
Similarly, some methods used to sterilize metal or plastic medical devices could damage or destroy human tissue. Instead, the tissue is treated in other ways to minimize contamination from microorganisms.
Sources: Food and Drug Administration; Dr. Matt Arduino, chief of the CDC Clinical and Environmental Microbiology Branch; American Association of Tissue Banks