Fort Lee, N.J. — In the wake of a Food and Drug Administration (FDA) investigation, the U.S. Centers for Disease Control and Prevention (CDC) has recommended that recipients of tissue implants supplied by Biomedical Tissue Services Ltd. (BTS) be tested for infectious diseases.
The FDA’s 2005 investigation of Fort Lee-based BTS uncovered inaccurate record-keeping, ineligible donors and failure to screen donor tissues for infectious diseases. The agency found that information regarding cause, place or time of death did not match up with data on donors’ death certificates; also noted were slipshod recovery methods that failed to control tissue contamination.
According to the Morbidity and Mortality Weekly Report, about 25,000 BTS tissue products were sent to five tissue processors and then distributed to all 50 states and internationally between June and October of 2005. In October, BTS and the five processors that received the tissues were ordered to issue a recall of all unused products. Recall letters were sent to providers that had bought the products and included a recommendation by the FDA and CDC that tissue recipients be notified of the recall and offered testing for HIV, hepatitis B and syphilis.
The CDC advised that involved patients whose tissue implants had been in place for longer than six months be tested. It also advised that patients who received tissue implants during the immediately preceding six months could also be tested, but should be re-tested after the six-month mark.
Further, the CDC said patients who test positive for an infectious disease should undergo more testing to confirm the diagnosis, and that positive test results should be reported to local or state health departments, the tissue distributor, the FDA’s MedWatch program or the CDC.
Doctors who don’t know the source of tissue they’ve implanted during this time period should contact the facility or distributor that provided the tissues, or call their state or local health department.
