FDAnews
www.fdanews.com/articles/89983-fda-urges-retesting-tissue-donors-to-decrease-communicable-disease-risk

FDA URGES RETESTING TISSUE DONORS TO DECREASE COMMUNICABLE DISEASE RISK

January 30, 2007

Establishments that make eligibility determinations for certain donated human cells, tissues and cellular and tissue-based products should retest donors to ensure that faulty testing methods do not allow communicable diseases to be transmitted through those products, the FDA says.

In Jan. 24 guidance, the Center for Biologics Evaluation and Research said it had found evidence that some companies improperly performed screening on pooled donor specimens, even though tests were supposed to be performed only on individual specimens. Some companies also used diagnostic tests on those specimens rather than FDA-licensed tests, the agency said.

Pooled testing and diagnostic tests are not as sensitive as licensed tests, so communicable diseases may have gone unnoticed, the agency concluded.

Companies are expected to quarantine the products in question and retest donors. The FDA also wants companies to use special warning labels on the products.

The guidance is available at www.fda.gov/OHRMS/DOCKETS/98fr/07d-0017-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0017-gdl0001.pdf).