CDC urges infection testing for tissue recipients

NEW YORK (Reuters Health) - Inaccurate record keeping, ineligible donors, and failure to screen donor tissues for infectious diseases have led the U.S. Centers for Disease Control and Prevention to recommend recipients of tissue implants supplied by Biomedical Tissue Services, Ltd, (BTS) of Fort Lee, New Jersey, undergo testing for infectious diseases.

Dr. M. Malarkey, from the US Food and Drug Administration (FDA), and associates report that, late last year, an investigation of BTS by the FDA revealed that information regarding cause, place or time of death did not match information on the donors' death certificates. They also found sloppy recovery methods that failed to control contamination of the tissue.

As reported in the Morbidity and Mortality Weekly Report, approximately 25,000 BTS tissue products were sent to five tissue processors and then distributed to all 50 states and internationally between June and October.

In October, BTS and the five processors that received the tissues were ordered to issue a recall of all unused product.

The recall letters were sent to the doctors and healthcare facilities that had bought the products and included a recommendation by the FDA and CDC that tissue recipients be notified of the recall and offered to be tested for HIV, hepatitis B, hepatitis B and syphilis.

In January of this year, the US Food and Drug Administration ordered BTS to cease manufacturing and distributing all cells, tissue, and cellular and tissue-based products. Most of the products were bone, skin, and soft tissue such as tendons.

Then in March, the FDA found out that some of the blood samples submitted for disease screening were not from the alleged donors.

The CDC advises that the involved patients whose tissue implants had been in place for longer than 6 months be tested. Patients who received the tissue implant less than 6 months earlier could also be tested, but retesting will the needed after the 6-month mark.

Patients with test positive for an infectious disease should undergo further testing to confirm the diagnosis, the authors note, and positive test results should be reported to local or state health departments, the tissue distributor, FDA's MedWatch program (http://www.fda.gov/medwatch) or the CDC (phone number 800-893-0485).

Patients who do not know where the tissue implants came from should ask their doctors. If the doctors don't know the source of the tissue, they should contact the facility or distributor that provided the tissues, or call their state or local health department.

MNWR, May 26, 2006.