CDC Issues Draft Guidelines for Testing Donor Transplant Organs

Cheryl Clark, for HealthLeaders Media, September 22, 2011

Federal disease investigators have looked into more than 200 cases of unexpected, suspected transmission of HIV, hepatitis B and hepatitis C through transplanted organs between 2007 and 2010, including some cases that led to the recipient's death. 

Now, the Centers for Disease Control and Prevention has issued a draft of stricter guidelines of what hospitals and others involved in the transplant process should do to prevent these tragic results. The proposed recommendations were last issued in 1994.

"Our first priority must be patient safety," said Matthew J. Kuehnert, MD, director of the CDC's Office of Blood, Organ and Other Tissue Safety Office. "The guideline will help patients and their doctors have information they need to fully weigh risks and benefits of transplanting a particular organ."

The agency's major draft recommendations include the following:

  • In addition to screening for HIV, the agency suggests that donors be screened for hepatitis B and hepatitis C viruses.
  • The agency suggests that labs conducting the testing use more updated and sensitive methods to test organs destined for transplant.
  • The agency recommends that procurement organizations and others involved in the process use a revised set of donor risk factors that can give clinicians a more thorough picture about possible risks associated with donors' organs.
  • Since the U.S. Food and Drug Administration has implemented more comprehensive regulations for tissue and semen donors, the agency suggests that centers focus on solid organs and vessel conduits and not other tissues.
  • The guidelines should apply to organ procurement organizations, transplant centers, clinical coordinators, lab personnel responsible for testing and storing donor and recipient specimens and those responsible for developing and evaluating infection control programs.

"We recognize that organ demand is much greater than availability," Kuehnert said in a statement. "This guideline will assist the transplant community in ensuring that each patient is protected against unexpected diseases from the organ they so desperately need."

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