Human Tissue Transplants : Sperm and Ova, Tissue Brokers

by Food and Drug Administration (FDA)

(Page 2 of 3)

Sperm and Ova

Reproductive tissues, primarily sperm and ova, are presently not regulated by the federal government and are exempt from FDA's interim rules. Though this industry has some degree of self regulation and state monitoring, it is not without its problems.

Last October, Congress heard testimony from New York state officials explaining that until the state tightened standards in 1989, many of New York's sperm banks had been based in physician's offices and often used fresh semen from untested donors. The officials identified other problems, such as employees' lack of technical expertise in infectious disease testing and inadequate screening of donors who designate a semen recipient. The state had also found a case in which two semen bank operators were using only themselves as donors but leading recipients to believe that the bank had stored semen from more than a dozen donors.

While emphasizing the potential of passing infectious disease through reproductive tissue, FDA officials also point out the possibility of transmitting inherited diseases. Based on these concerns, Congress is now considering legislation that would give FDA regulatory oversight of sperm and ova banks and make these facilities accountable to rigid standards. Meanwhile, FDA cautions persons who intend to use donated reproductive tissue to discuss with their doctors the screening and testing standards under which the tissue was collected and insist on documentation.

Tissue Brokers

FDA put its new regulatory controls (see accompanying article) into action last February when it ordered an El Paso, Texas, tissue-processing firm to retain or destroy stored tissue and recall previously distributed tissue from about 180 donors. The agency determined that the firm, AlloTech, which imported tissue from Eastern Europe, lacked adequate documentation of medical history screening and disease testing for the tissue. There was no evidence that AlloTech's donors carried any of the target diseases, but FDA saw the firm's shortcomings as a potential hazard.

AlloTech had dealt with "tissue brokers" marketing donor cadavers from former Soviet bloc countries. FDA's concern was that certain brokers could not produce original records of donor screening or donor consent.

In a 1993 investigation of imported tissue brokers, FDA found no proof of disease transmission from any of these products. Further, the agency points out that some tissue banks may import human tissue legitimately with the proper documentation.

In its investigation, FDA collected revealing evidence about the credibility of some tissue brokers. FDA investigators placed an order for cadavers after contacting two brokers representing interests in former Soviet bloc countries. One broker, claiming the bodies tested disease-free, gave investigators four vials of blood taken from the cadavers. FDA analyzed the samples and found that one tested positive for the hepatitis B virus.

At the time, no federal regulatory provisions existed that would allow FDA to take direct action. Now, under the agency's interim rules, FDA can crack down on noncompliant brokers. An "import alert," put in place last December, requires any tissue importer to notify FDA before bringing foreign tissue into the country.

Acknowledging that importing potentially tainted tissue is "something that has happened," Jim Weixel, spokesman for the AATB, says, "it's not really a big problem in this country. The amount of tissue that comes in from overseas, as far as we know, is very small compared with that recovered domestically." He adds, however, that because reporting was never required, "nobody really has accurate statistics" on tissue importation.

Legislation Introduced

Over the last several years, Sen. Paul Simon (D-Ill.) and Rep. Ron Wyden (D-Ore.) have examined safe and effective use of human tissue transplants. Wyden, key sponsor of a tissue-regulation bill in the House of Representatives, has spoken out about other problems with tissue banking besides disease transfer and imported products. In congressional testimony last October, he called for a halt to "practices that damage tissue and render it useless."

For example, he cited "over-freezing for preservation" and "zapping them with too many gamma rays to irradiate disease" as tissue-banking "practices that must be stopped." Also, he said, "there must be further scrutiny of sterilization methods currently in use which leave cancer-causing residues."

Further, he pointed out disparities in training levels of persons who collect, process and store tissues. He called for uniform training standards that would be required of all banks. On Nov. 19, 1993, both Wyden and Simon introduced similar tissue- banking legislation. At press time, both bills still were pending.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.