FDA orders N.J. tissue recovery firm being monitored to close

Inspections uncovered violations of human tissue product manufacturing regulations that could increase public health risk.

As part of an ongoing investigation of a Fort Lee, N.J. tissue recovery agency, the FDA has ordered the firm and its top executive to immediately cease operations.

The FDA recalled human donated tissues recovered by the firm, Biomedical Tissue Services Ltd. (BTS), last fall. FDA officials said in a press release issued Feb. 3 that they were monitoring those recalls to ensure all distributed tissue has been accounted for.

“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,” FDA Associate Commissioner for Regulatory Affairs Margaret O'K. Glavin said in the release.

In addition to suspending all of its manufacturing functions — not just the recovery and shipment of human cells, tissue and cellular- and tissue-based products (HCT/Ps) — the FDA also required BTS and its CEO and Executive Director of Operations, Michael Mastromarino, DDS, to retain all HCT/Ps.

Inspection findings

A copy of the order to cease manufacturing and retain HCT/Ps, posted at the FDA Web site dated Jan. 31, said the action “relates exclusively to conduct occurring on or after May 25, 2005.” It detailed specific deficiencies in BTS’ standard operating procedures and other processes. It also stated that BTS could resume manufacturing once it complied with FDA regulation CFR Part 1271.

This recent action stemmed from FDA’s October inspection of BTS, which uncovered violations of key regulations that could affect steps in the tissue recovery process, such as donor screening and recordkeeping. BTS also failed to follow its own standard operating procedures and failed to perform HCT/P recovery in such a way that could not cause contamination or cross-contamination during tissue recovery, the statement said.

The violations cited included inadequately screening donors for risk factors for or clinical evidence of various communicable diseases.

FDA officials also found discrepancies between donor paperwork that BTS maintained and information contained in donor death certificates filed with state officials where the deaths occurred, the release said.

Safety measures

“FDA’s current regulatory framework for HCT/Ps provides strong measures that the agency can utilize to prevent the introduction, transmission, or spread of communicable diseases by HCT/Ps, and requires firms to screen and test donors for relevant communicable disease agents and diseases to ensure that HCT/Ps are processed in such a way that prevents communicable disease contamination and cross-contamination,” Jesse L. Goodman, MD, MPH, director of the FDA’s Center for Biologics Evaluation and Research, said in a prepared statement.

“This is the first time in tissue banking ... that we've ever had a situation where it is alledged that somebody falsified donor consents and medical histories. This just has never happened ... so everybody’s appalled by this,” said P. Robert Rigney Jr., JD, chief executive officer of the American Association of Tissue Banks (AATB), McLean, Va. The AATB accredits U.S. tissue banks. However, BTS had never received AATB accreditation, Rigney noted.

Industry concern about ramifications of the BTS situation is significant, Rigney told Orthopedics Today. “It goes to the very nature of what we do, informing potential donors and their families, giving them the option to donate, and letting them make the decision. This undermines that process and it increases the anxiety of patients who received transplants.”

Minimal impact

So far, the tissue banking industry has noticed no direct impact from the situation.

“If there is a direct impact, we’re not going to see it for a while, but we believe that the public is intelligent enough, and after listening to both sides, will understand that this is an aberration. It’s never happened before,” Rigney said.

He confirmed there have been no reported cases of disease transmission from the BTS-recovered tissue, adding that the five tissue processors who did business with BTS and recalled tissue related to the case were all AATB-accredited. Because of the multiple donor tests and screening procedures these organizations perform on all donated human tissue, the risk of communicable disease transmission should be extremely low, Rigney said.

“Particularly with bone, it goes through a final process where the allografts are irradiated at mega doses that would kill bacteria and viruses that may have survived,” he said.

For more information:
The BTS cessation order can be viewed at fda.gov/cber/compl/bts013106.htm.