In this version of DOK’s corner, I have included a copy of the U.S. Food and Drug Administration (FDA) letter announcing the order to Donor Referral Services (DRS), a human tissue-recovery firm, of Raleigh, NC, to immediately cease all manufacturing operations, and to retain human cells, tissues and cellular and tissue-based products (HCT/Ps) after an inspection found serious deficiencies in its practices. This is the second major FDA action against a tissue bank because “The agency has determined that because of the serious nature of these violations, there are reasonable grounds to believe that they present a danger to public health.”
The previous case had major media attention because the tissue bank, Biomedical Tissue Services, had collected tissue from donors without permission and with inaccurate medical records and cause of death. The most famous donor in that incident was Alistair Cooke from Masterpiece Theater, whose body parts were collected without permission and his age and cause of death were falsified.
As in the previous case, I expect recall of all tissue collected by this bank for more than a year. These recalls present numerous and significant risks to the hospitals that used the tissue. In the last recall the recipients had to be notified and tested to evaluate the degree of risk from the tissue transplant. Unfortunately, many hospitals could not identify who received the tissue and many patients have still not been notified and afforded medical treatments putting themselves and families at further risk. In addition, some hospitals could not find unused tissue in their hospital and the tissue was transplanted after the recall putting the hospital in great danger of liability.
Besides these highly publicized situations, there have been cases of fatal and near fatal cases of Clostridia, Strep pyogenes, rabies and other bacterial and viral diseases associated with the transplant of tissue. Because of these threats, the Joint Commission has published standards for hospitals on the use of tissue including tracking and tracing of recipients.
We at Biomedical Synergies have developed proprietary software to help hospitals track and trace transplanted tissue to recipients. During our work with hospitals, we have learned that such software, while an important component, is only part of an integrated, comprehensive program necessary to meet standards and provide for safe tissue. Hospitals need to review their policies and procedures involved in receiving and return of tissue, storage, issuance and reconstitution to ascertain if they do indeed meet standards. Many hospitals think they have good systems in place until a major event such as a recall occurs and they discover they are totally unprepared.
During the current crisis in trust of tissue products, hospitals don’t have the luxury of discovering that their systems aren’t up to par. Compliance is not an optional nice-to-do but an essential program to guarantee patient safety and decrease the risk of liability. |
