Medical Device Daily Associate

Under its comprehensive framework for ensuring the safety of human tissue products, the FDA has ordered Biomedical Tissue Services (BTS; Fort Lee, New Jersey), a human tissue-recovery firm, and its CEO and executive director of operations, Michael Mastromarino, to immediately cease all manufacturing operations.

All tissue products initially recovered from human donors by BTS were recalled. The FDA said it is monitoring these recalls to account for all of the tissue distributed.

“FDA's investigation of BTS revealed serious and widespread deficiencies in their manufacturing practices that provide the agency reason to believe that allowing the firm to manufacture would present a danger to public health by increasing the risk of communicable disease transmission,” said Margaret Glavin, associate commissioner for regulatory affairs at the agency.

Jesse Goodman, MD, director of the Center for Biologics Evaluation and Research, added: “FDA's current regulatory framework for Human Tissue and Cellular and Tissue Based Products (HCT/Ps) provides strong measures that the agency can utilize to prevent the introduction, transmission or spread of communicable diseases by HCT/Ps, and require firms to screen and test donors for relevant communicable disease agents and diseases and to ensure that HCT/Ps are processed in a way that prevents communicable disease contamination and cross-contamination.”

The FDA order to cease manufacturing and to retain HCT/Ps requires BTS to suspend all manufacturing, including but not limited to the recovery and shipment of HCT/Ps.

The agency's inspection of BTS uncovered serious violations of the regulations governing donor screening and record keeping practices, as well as failures to follow its own standard operating procedures (SOPs), failure to recover HCT/Ps in a manner that does not cause contamination or cross-contamination during recovery, and failure to adequately control environmental conditions.

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, the FDA found numerous instances where death certificates maintained in BTS's files were at variance with the death certificates the 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.

An article in the Washington Post last month alleges that Mastromarino, a former dentist, went to various New York City funeral homes and extracted bone, tendons and skin from corpses without the consent of relatives, including the late Alistair Cooke, host of PBS's Masterpiece Theatre.

The company, which was not an accredited member of the American Association of Tissue Banks (AATB; McLean, Virginia), shipped coolers full of tissue to five suppliers across the nation.

The FDA previously listed five companies as processors receiving the tissues from BTS: LifeCell (Branchburg, New Jersey); Lost Mountain Tissue Bank (Kennesaw, Georgia); Blood and Tissue Center of Central Texas (Austin, Texas); Tutogen Medical (Alachua, Florida); and Regeneration Technologies (RTI; Alachua, Florida).

This past October, LifeCell reported its late-September recall of certain products – brand-named AlloDerm, Repliform and GraftJacket – following investigation of documentation from BTS. The FDA also reported a tissue recall by Lost Mountain Tissue Bank in October, and RTI on Oct. 14 issued a statement reporting its recall of tissues.

Robert Rigney, CEO of the AATB, told Medical Device Daily that 95% of retrieval for all tissue donors takes place in a hospital setting, with the remaining 5% of donations taking place in a funeral home, coroner's office or in a surgical suite onsite at a tissue bank.

While he said this latest incident is an aberration in what is otherwise a well-run, above-board business, Rigney conceded that it could have a negative affect on future tissue and organ donation.

“This is the first time, certainly in the history of this association which goes back 29 years, that we've ever run across an instance where people were alleged to have falsified donor consent and perhaps donor records. This flies in the face of everything that we're about and everything that we're trying to do,” he said.

While no one knows exactly how many patients are affected, some examples uncovered so far are suggestive:

Between early 2004 and September 2005, 60 surgical patients at Shore Memorial Hospital (Somers Point, New Jersey), received implants said to have originated with the corpse-snatching ring. Another 74 patients in Nebraska received stolen bone tissue during surgeries in the same period.

In the Post article, Mastromarino's lawyer, Mario Gallucci, maintained that his client never broke the law, saying it's the funeral parlor's job to obtain consent from prospective donors. Mastromarino and his employees would simply show up and harvest tissue, taking a cursory look to make sure it was viable and the body as described, Gallucci said.

Rigney said he doubted anyone now living with tissue originating from BTS is in any kind of health danger, because the processors the company dealt with would have subjected any tissue to screening. Still, he said he is appalled. “If these people did what is alleged here, what they have done is unconscionable.”

After initially focusing efforts on assessing the safety of distributed tissues and facilitating the appropriate recalls, the agency has determined that BTS's violations, because of their serious nature, constitute a danger to health and is taking this unprecedented action.

The FDA continues to investigate BTS's activities and to work with tissue processors and federal, state and local authorities, and will take further actions as needed, it said.

The FDA began regulating tissue banks in 1992.