FDA urges testing of patients who received DRS-recovered tissue

The FDA issued a guidance to manufacturers in the tissue industry urging them to comply with FDA regulations.

Similar to last year's human tissue recall, the FDA has again recommended that patients who received possibly contaminated human tissue in association with another tissue recall to undergo infectious disease testing.

This time the safety concern relates to tissue recovered by Donor Referral Services (DRS), of Raleigh, N.C., which may not have adhered to FDA donor eligibility requirements, according to an FDA-issued public health notification.

The FDA has not received any reports of adverse reactions from already-implanted tissues, the agency noted.

The agency also issued a guidance to manufacturers in the tissue industry on Sept. 13 urging them to immediately comply with FDA regulations concerning human cells, tissues, and cellular- and tissue-based products (HCT/Ps), 21CFR Part 1271.150(c)(1). "The guidance is intended to ensure that companies involved in any or all steps in the recovery, processing, storage, labeling, packaging or distribution of any human cell or tissue, and screening or testing of the cell or tissue donor, are aware of their regulatory responsibilities," FDA officials said in a press release.

The FDA has also formed a multidisciplinary Human Tissue Task Force (HTTF) to evaluate cell and tissue safety issues, which will be led by senior officials at the Center for Biologics Evaluation and Research (CBER) and the Office of Regulatory Affairs.

"The main priority of HTTF will be to assess the effectiveness of the implementation of the new tissue regulations, which went into effect in 2005. Of particular interest will be a review of recently reported findings that some tissue recovery establishments are not following federal requirements for tissue recovery," FDA officials said in the release.

Last year, the agency shut down another tissue recovery firm, New Jersey-based Biomedical Tissue Services (BTS), for failing to follow those requirements.

On Aug. 18, the FDA ordered DRS and its owner, Philip Guyett, to cease manufacturing and retain HCT/Ps. According to a letter the FDA sent to Guyett, the order followed the FDA's inspection of DRS manufacturing facilities on June 28 and 30, which uncovered "significant violations" of 21 CFR, part 1271, the federal regulatory code governing HCT/Ps.

A small percentage of the overall U.S. tissue supply was affected by the recall, according to FDA and American Association of Tissue Banks documents.

For more information:
The guidance for industry is available at: www.fda.gov/cber/gdlns/cgtpmanuf.htm.
The FDA public health notification related to Donor Referral Services is available at: www.fda.gov/cber/safety/drs083006.htm.
The FDA order for Donor Referral Services to cease operations is available at: www.fda.gov/cber/compl/drs081806.htm.