Tissue Implants and Biomedical Tissue Services (BTS)

In March of 2006, the Food and Drug Administration (FDA) issued a public health notification regarding Biomedical Tissue Services (BTS). According to the notification, the FDA strongly recommends that health care providers inform their patients who received tissue implants prepared from BTS donors that they may be at increased risk of communicable disease transmission and to offer them testing.

The following is an excerpt from the FDA public health notification about BioMedical Tissue Services (BTS):

On October 26, 2005, FDA issued an information paper regarding its investigation of BTS. FDA expressed concern that BTS had supplied tissue from donors that had not been subject to an adequate donor eligibility determination. FDA and CDC recommended that health care providers inform their patients of this potential risk and offer to provide access to appropriate infectious disease testing.

Donor eligibility is determined through donor screening and donor testing. Donor screening involves reviewing all relevant medical records, physically assessing the donor and questioning the donor’s next-of-kin to determine whether risk factors for or clinical evidence of relevant communicable diseases exist.

On January 31, 2006, FDA issued an Order to Cease Manufacturing and to Retain Human Cells, Tissues and Cellular and Tissue Based Products (HCT/Ps) to BTS and its Chief Executive Officer and Executive Director of Operations. The order was issued after FDA's inspection of BTS uncovered serious violations of the regulations governing donor screening and record keeping practices. Despite records maintaining otherwise, the firm had inadequately screened donors for risk factors for, or clinical evidence of, relevant communicable disease agents and diseases. In addition, FDA found numerous instances where death certificates maintained in BTS' files were at variance with the death certificates FDA obtained from the state where the death occurred, on important information such as cause, place, and time of death, and the identity of the next of kin. Therefore, the donor screening performed cannot be relied on to exclude donors with risk factors for or clinical evidence of infectious disease.

FDA regulations require that, before tissues are released for distribution, blood samples from each donor be provided to the testing laboratory for donor testing. Each sample must be clearly linked to an individual donor, and each tissue clearly linked to that donor. FDA and the affected processors now have additional information that calls into question the reliability of some of these donor blood samples submitted for communicable disease testing from BTS tissue donors. In some instances, blood samples did not come from the same donor as the linked tissues. Therefore, the results of communicable disease tests obtained from the blood sample may not correctly reflect the status of the donor.

For the full FDA Public Health Notification, click here.

Updates to Recall of Biomedical Tissue Services Human Tissue

May 19, 2006 – The CDC's Mortality and Mordity Monthly Report (MMWR) gives synopsis of their investigation into the human tissue illegally harvested by Biomedical Tissue Services. Read the CDC article.

May 6, 2006 –In response to the Biomedical Tissue Services recall and scandal, U.S. Rep. Frank Pallone Jr., D-N.J., and U.S. Sen. Charles Schumer, D-N.Y., have introduced House and Senate versions of the "Safe Tissue Act," which includes provisions to create safeguards and oversight of the human tissue industry.

April 18, 2006 – It is now believed that Biomedical Tissue Services (BTS) illegally harvested human tissue from up to 30 funeral homes. The illegal tissue harvesting was first discovered by New York City police in November 2004. It was not until October 2005 that the FDA began investigating Biomedical Tissue Services for not properly screening the body parts for disease.

March 18, 2006—Tissue, bones and tendons implanted by hospitals and dentists may have been improperly screened for serious diseases, including HIV, Hepatitis B, pathogen and syphilis. Biomedical Tissue Services (BTS) allegedly improperly gathered and screened tissue, bones, and tendons. BTS tissue was distributed by Regeneration Technologies, LifeCell Corporation, Tutogen Medical Inc., Lost Mountain Tissue Bank, and Blood and Tissue Center of Central Texas. Medtronic also used BTS tissue. Health officials are still unsure of the number of patients who had BTS tissue implanted, although the Food and Drug Administration (FDA) has made a preliminary estimate of 13,000.

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