A New Jerseybased biomedical company accused of questionable acquisition of human tissue samples was issued an Order to Cease Manufacturing by the Food and Drug Administration (FDA) on February 2, citing procedural failures in recordkeeping, donor eligibility, and handling of the tissue materials. The University of Chicago Hospitals (UCH) is among the hundreds of medical facilities nationwide that received the questionable tissue for patient use.
Biomedical Tissue Services, Ltd. (BTS) manufactures human cells, tissues, and cellular and tissue-based products (HCT/Ps) and, according to an FDA investigation, has been found in gross noncompliance with federal health and safety standards.
According to the FDA, the questionable tissue material found its way into 10 hospitals and 62 patients in the Chicago area, including Northwestern Memorial Hospital and UCH.
The tissue was recovered by BTS from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases, according to an FDA statement. At this time, the implicated tissues from BTS include human bone, skin, and tendons.
The BTS tissue is used for products that make up a small percentage of the entire U.S. tissue supply, according to the statement.
John Easton, director of Media and Public Affairs for UCH, acknowledged that despite the threats posed by BTS tissue, the Hospitals had taken adequate steps to ensure the safety of its patients before learning about the FDA announcement.
The tissue had all been processed properly, but it was appropriate consent and screening that was lacking, Easton said. The problem was in the acquisition.
Companies similar to BTS obtain consent to acquire a donors tissue after death, which then undergoes specialized processing and treatment for potential use in hospitals.
The processing part is where all the safety issues come up, Easton said. These acquisition companies proceed to distribute the tissue material to a supplier company whose sole purpose is to sell the tissue to hospitals across the nation.
We dont deal in any way, shape, or form directly with that one company [BTS], Easton said, adding that the Hospitals are still using the same supplier company, which, he emphasized, was not accountable for the delivery of questionable tissue from BTS.
The typical process of obtaining tissue for patients involves multiple levels of communication between clients and vendors. Easton explained that an acquisition company such as BTS first physically acquires and prepares tissue from donors. These companies then send the tissue samples to supplier companies, who then sell the tissue to hospitals such as UCH. As a result, hospitals and supplier companies have no responsibility in the quality of tissue samples provided by acquisition companies like BTS.
According to Easton, three patients received tissue acquired by BTS, but none was infected. Easton said that tests for potential infection were offered as a precautionary measure but that none of the patients has elected for that option. The FDA has reported no complaints thus far from patients who received the tissue material and estimated that the risk for infection was low despite questionable BTS testing for HIV-1 and 2, hepatitis B and C virus, and syphilis.
The UC Hospitals primarily uses HCT/Ps in cardiac surgery, reconstructive surgery, and wound closure procedures that often involve bone tissue, Easton said.
The FDA inspected BTS facilities in Fort Lee, New Jersey, throughout October 2005, along with a number of funeral homes that supply BTS with potential donor tissue. The investigation found that FDA regulations for donor eligibility and donor screening were not met by BTS, threatening a spread of communicable diseases to patients who received the materials.
Easton said that UCH had taken its own initiative to notify patients of the questionable tissue following the FDAs report in October 2005.
According to the FDAs findings, the violations at BTS posed a danger to public health, and the company was issued an Order to Cease Manufacturing that went into immediate effect as of January 31, 2006. Pending further investigation, BTS could face criminal charges for any further shipment of tissue materials.
In its report of inaccurate recordkeeping and questionable practices, the FDA referred to BTSs reports that one donor was 63 years old and had died from an acute myocardial infraction, while state death certificates listed the donor as 79-years-old whose cause of death was pneumonia due to myocardial infraction.
Another citation included BTSs documentation of a supposedly 44-year-old donor who died from blunt trauma in a car accident, while state records showed that the donor was 48 years old and had died of congestive cardiac failure due to cardiovascular disease.
BTS also violated FDA regulations involving donation consent and donor eligibility requirements. The FDA report cited multiple instances in which BTS claimed to have listed a donors spouse as the consenting next of kin, when further investigation found that the donors spouse was incorrectly listed as another person living at a completely different address than BTS documentation showed.
Violations of donor eligibility requirements illuminated some of the most outward threats to public safety. The FDA found that BTS had failed to recover donor tissue using uncontaminated methods and had improperly refrigerated the tissue samples, leaving the material prone to the transmission of communicable diseases, according to the report.
Its not honoring the wishes of the potential donor, Easton said of the companys false practices. The medical concern is that this tissue is not going through the screening for infectious diseases.
The Kings County District Attorneys Office in New York is also investigating the case but declined comment pending its ongoing probe of the company.