FDA Shuts Down Another Organ/Tissue Transplant Service

By Linda Orlando

The tissue transplant industry is suffering from yet another scandal, with the FDA forcing the shutdown of Donor Referral Services. The FDA said that an inspection revealed "serious deficiencies in its manufacturing practices, including those governing donor screening and record keeping." DRS and its owner, Philip Guyett, have been ordered to immediately suspend all manufacturing, including the recovery and shipment of human cells, tissues, and cellular and tissue-based products.

The tissue products supplied by DRS to hospitals and clinics were recovered in an unsterile embalming room that was used to carve up dozens of corpses. Tissue that is not properly processed, or not tested appropriately, can cause the recipient to contract chronic infections such as hepatitis or AIDS, or even death. The FDA did not provide information about how many people may have received contaminated tissue, but hundreds of human tissue products destined for transplants across the country have been recalled.

The FDA also discovered serious violations of administrative regulations, including instances where records provided by DRS to another tissue bank did not match the official death certificates the FDA obtained from the state where the death occurred. Saying that patient safety was at the forefront of the FDA’s decision to close DRS, Margaret O'K Glavin, Associate Commissioner of the FDA’s Office of Regulatory Affairs, said, "Allowing the firm to continue to manufacture would present a danger to public health by increasing the risk of communicable disease transmission."

The tissue-implant business has been booming in recent years, thanks to remarkable developments and advances in reconstructive surgery and a variety of procedures that can save lives, repair limbs, relieve pain or enhance a patient's quality of life. The FDA implemented new tissue regulations in May requiring firms to properly screen and test donors. The regulations, when necessary, enable the FDA to take swift action in the interest of public health whenever questions arise. "While most tissues are obtained and manufactured using appropriate protections, some operators are not following acceptable practices," said Jesse L. Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research.

Last year, Biomedical Tissue Services of New Jersey was accused of using undocumented stolen bodies and shipping nearly 20,000 potentially tainted body parts. Dozens of patients received implants of human tissue stolen from funeral homes in New York, Pennsylvania, and Florida. All of the patients were notified and tested for infectious diseases, and none were found.

So far the FDA has not received any reports of adverse reactions by patients who have already received implants, but they will continue to investigate and monitor the situation.