Public Health

CDC urges some allograft recipients to undergo testing for infectious diseases

Last Updated: 2006-05-25 14:07:18 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Inaccurate record keeping, ineligible donors, and failure to screen donor tissue for infectious diseases have led the US Centers for Disease Control and Prevention to recommend that recipients of tissue implants supplied by Biomedical Tissue Services, Ltd, (BTS, 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 from 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 for May 26, approximately 25,000 BTS-recovered tissue products had been sent to five tissue processors and then distributed in all 50 states and internationally between June and October.

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

The recall letters sent to the clinicians and healthcare facilities that had bought the products included a recommendation by the FDA and CDC that tissue recipients be notified of the recall and offered testing 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 or demineralized bone matrix, skin, and soft tissue such as tendons and fascia lata.

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 less than 6 months earlier can also be tested, but they should be retested after the 6-month mark.

Those who test positive should undergo confirmatory or supplemental testing, the authors note, and positive test results 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 their allografts had come from should ask their physicians, according to the report. If physicians 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.

Mor Mortal Wkly Rep CDC Surveill Summ 2006;55:564-566.