CDC Recommends Improved Screening of Organ, Tissue Transplants, Releases Reports on Transplant Patient Deaths

The CDC yesterday called for improved screening of organ and tissue transplants as it issued separate reports linking three transplant patients' deaths to infections, including two from a rare disease previously confined to Latin America, the AP/South Florida Sun-Sentinel reports. In the first report, the CDC determined that three patients contracted a parasitic disease after receiving organ transplants from the same donor, a Central American immigrant, becoming the first such documented cases in the United States. The immigrant was apparently infected with T. cruzi, a parasite that causes Chagas disease, an ailment common in Latin America that can lead to heart irregularities. While the disease was detected in all three transplant patients, only two died last year after antibiotic treatment failed; the third is recovering (McClam, AP/South Florida Sun-Sentinel, 3/15). The second CDC report detailed 26 bacterial infections traced to tissue grafts in the United States, including an infection contracted by a 23-year-old Minnesota man who died last November following reconstructive knee surgery (Greene, Wall Street Journal, 3/15). The CDC said that a single tissue-processing company -- not named by the agency but "widely identified as CryoLife Inc.," according to the New York Times -- had been involved in 14 of the 26 contaminated grafts, including the fatal case of Brian Lykins. The agency found that the tissue that infected Lykins had not been refrigerated until 19 hours after the death of the tissue donor, "by which time lethal bacteria from his intestines" might have moved elsewhere in the donor's body (Blakeslee, New York Times, 3/15).

CDC officials have contacted health regulators and organizations that collect tissue and organs in an attempt to develop better organ screening and more sanitary tissue processing. "We are certainly identifying areas where we think there can be improvement in the standards of screening these tissues ... to make them as safe as possible," CDC medical epidemiologist Daniel Jernigan said. The CDC is working with the United Network for Organ Sharing, the organization that runs the nation's transplant system under an HHS contract, to develop a screening method for Chagas disease, which kills about 50,000 people in Latin America each year (Wall Street Journal, 3/15). The CDC estimates that up to 100,000 Latin American immigrants in the United States may carry the T. cruzi parasite, which leads to full-blown Chagas disease in 10% to 30% of cases. "It's a complex issue," Dr. Barbara Herwaldt, a CDC epidemiologist, said, adding, "Which donors would be screened? What test would be used? Right now even blood donors aren't screened for this infection."

As for the tissue report, the agency did not name CryoLife or assign blame for the 26 cases of contamination, saying that standards for the tissue transplant industry in general are "not tough enough to eliminate the bacteria responsible for most of the infections" (AP/South Florida Sun-Sentinel, 3/15). CDC recommendations for preventing contamination will be discussed by the FDA's Blood Products Advisory Committee today (Wall Street Journal, 3/15). The FDA, which currently inspects tissue banks but has only modest oversight of them, is writing new regulations that will "govern good practices," agency spokesperson Lenore Gelb said. Roy Vogeltanz, vice president of corporate communications for CryoLife, the largest of six companies that collect and prepare tissue for transplant, said it would consider the CDC's recommendations "and see if they improve tissue processing quality, given our knowledge and experience." The tissue industry, which collects and distributes such materials as heart valves, tendons and bones but not whole organs, has come under greater federal scrutiny as it grows rapidly. In 1999, tissue processors distributed 650,000 grafts, Jernigan said. While there have been few reported complications, he said that contamination might be underreported among older patients whose doctors fail to make a connection between their illness or death and faulty tissue (New York Times, 3/15). The CDC studies and recommendations, published in this week's Morbidity and Mortality Weekly Report, are available online.