In addition to transmitted infections, transmitted malignancies have been reported primarily through organ transplantation but have also been transmitted by stem cells and cornea. Beyond disease transmission, other concerns include adverse allergic reactions, reaction to toxins, or decrease in expected function. These non-infectious events may be due to deficiencies in the product, or a mismatch between the product and recipient immunologic profile, but consequences may be as severe as for infectious disease transmission events. In all of these adverse incidents, the ability to trace potential outcomes becomes exceedingly important.
Traceability’ means the ability to locate and identify the tissue/cell during any step from procurement, through processing, testing and storage, to distribution to the recipient or disposal, which also implies the ability to identify the donor and the tissue establishment or the manufacturing facility receiving, processing or storing the tissue/cells, and the ability to identify the recipient(s) at the medical facility/facilities applying the tissue/cells to the recipient(s). Traceability also covers the ability to locate and identify all relevant data relating to products and materials coming into contact with those tissues/cells.
As previously described, the donor scandal in New York State resulted in tissue from over 1,000 donors being recovered during a three-year period of time. Nearly 50,000 tissues were produced of which 15,000 could be recalled prior to transplantation. Over 25,000 tissues were distributed to unsuspecting patients without appropriate testing or medical review . Because records from these donors had been forged, over 2,000 of these tissues were untraceable including 800 that had been distributed outside of the United States. The real concern however, is that even apart from these unusual scandals, there is not a uniform system for tracking many of these tissues, nor to detect adverse events from their use. In fact, most of the reported infectious transmissions from tissue transplants have included the inability to identify some of the recipients.
In addition, the organ, tissue and eye banking community’s function independently and communications between them are often lacking. This lack of communication can result in an inability to track organs and tissues from a common donor. For example, a report in 2005 described a number of hepatitis C virus (HCV) transmissions to several organ and tissue recipients from a single donor. This case generated much publicity because there were 91 grafts produced from the donor (7 organs, 2 corneas and 82 other tissues), 44 transplants and 40 recipients in 16 states and 2 other countries over a period of 22 months. Three organ recipients were infected and 32 of the tissue recipients could be identified and tested of which 5 were HCV positive and infected. One recipient could not be identified. All of the tissue recipient infections would have been prevented if recognition of infection in the organ recipients had resulted in notification of the tissue bank before tissue was processed or released. More than 6 months elapsed between recognition of the organ recipient infections, donor linkage, and the time that tissue was processed . Events of this nature can only be avoided by the introduction of a comprehensive and unified traceability system covering all biologics derived from a single donor.
The increased recognition of issues related to traceability has resulted in various professional Associations strengthening their standards and Governments taking actions in adding to existing regulations. The International Society of Blood Transfusion (ISBT) charged its Working Party on Automation and Data Processing [subsequently renamed the Working Party on Information Technology (WPIT)] with creating a standardized means of labeling blood products so that identifiers were globally unique and bar codes (as well as other means of electronic information transfer) would have the same meaning internationally. The new coding system was named ISBT 128. The '128' in ISBT 128 comes from the barcode symbology which was selected at the time the standard was developed - this symbology is called Code 128, so the ISBT coding system using Code 128 bar codes became known as ISBT 128.
Although the transfer of blood across national boundaries is not a common occurrence, the situation for cells and tissues is very different. For this reason the case for globally unique identification is at least as strong as that for blood transfusion. A globally unique identification system is required, and this should extend across all biologic materials – blood, cells, tissues and organs. International Cell Therapy Associations, as well as International Eye Banking Associations, have agreed to the adoption of standard terminology and the ISBT 128 system and implementation is underway. The tissue banking and organ transplant communities are also in the process of determining how this system might be accepted and implemented .