It’s not likely that you’ve put much thought into the process of storing human donor tissue that are used in surgeries on a daily basis. I don’t believe this is just one of those things that the normal person thinks about. But what does happen to the tissue? How do we know it’s safe for usage?
An investigation by NPR and the International Consortium of Investigative Journalists (ICIJ) found that there’s little scrutiny at key points in the tissue donation and transplant process.
So What Exactly Are We Talking About?
Tissue is anything that’s not a live organ and can be recovered from a dead body. It can then be turned into scores of medical products. 1.5 million of these products are given to American patients every year.
The donor’s health must be carefully screened to ensure that the tissue is safe for use. Then the tissue must be removed from the body under sterile conditions, and processed in a precise way to prevent contamination and damage. Finally it is stored at exact temperatures with an expiration date.
NPR and ICIJ found that the tissue donation process is not secure and donations are difficult to track. A representative from the American Association of Tissue Banks, the industry trade group, disagrees.
“We are very highly regulated,” Dr. David Smith said, noting that medical advances with tissue come so quickly that regulators have a hard time keeping up or staying out of the way. “That’s what we worry about. Will the regulations affect our ability to come up with new ideas?”
Smith, a forensic pathologist, says the industry has a good safety record, and he’s right. Serious problems are rare. But when there is one, it’s difficult to catch, and the consequences could be life-threatening.
Such as what happened last year when officials at the federal Centers for Disease Control and Prevention faced a rare health emergency and had limited ability to control it.
After a Kentucky man died, his organs and tissue were donated for transplant. The donation was tested to make sure the donor was free from disease, but a lab technician misread the results.
Several months later, the organ recipients started showing symptoms for hepatitis C.
“They were diagnosed with hepatitis C. And then it was very, very important to get that word to the tissue banks and then to the hospitals and health care facilities,” says Matthew Kuehnert, a doctor at the CDC whose job it is to protect donated blood, organs and tissue. Blood and organs are closely tracked, but tissue is not.
“The race was on,” he says, to alert hospitals and find where the donated tissue might have gone. In this case, 44 ligaments, tendons and other donated tissue were sent to hospitals and clinics around the country. Unlike organs, which are quickly transplanted, tissue can be saved and stored for use at a much later date.
A month later, the CDC found 15 people already had been implanted, and one child did indeed contract the infection.
Kuehnert suggests the process of receiving tissue should be similar to buying cereal at the grocery store.
“It has a bar code on it, and it can be tracked back if there is some sort of problem with it in terms of quality,” he says. “You can’t do that with tissue right now. And that is a gap.”
The CDC — largely because it can’t track that tissue — has little idea how many times someone gets an infected transplant.
The primary regulator of tissue is the federal Food and Drug Administration. But it relies upon the industry to mostly police itself. If a doctor reports that a patient contracted an infection after a transplant, it is up to the tissue bank to decide whether it is a clear-cut case that needs to be reported to the FDA.
The FDA says it continues to evaluate the need for new regulations.
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