Management of non-human tissues by a tissue bank/transplant program

A medical technologist in Mississippi reports that her hospital blood bank oversees the tissue bank/ transplant program at their facility. She wonders if non-human tissue falls under the same guidelines for storage, receipt, tracking and distribution as human tissue. They store the following non-human tissues

Dura-Guard® - Bovine Pericardium
Durepair® Dura Regeneration Matrix- Collagen implant for the repair of defects in the dura mater - Bovine skin
PriMatrix - an acellular dermal tissue derived from fetal bovine dermis
Surgisis® Gold™ Hernia Repair Graft - derived from a porcine source

She would like to know if other blood banks store non-human tissues like those listed above (or similar items). If so, are the guidelines for storage of these materials the same or different than those used for human tissues? If different, what guidelines are followed?

The following comments have been submitted.

ADDENDA January 3, 2009

1. A Biovigilance Program Manager in a Perioperative Services Program reports that in her experience, although most hospitals follow Joint Commission standards for human tissue, she has learned first hand that the FDA is concerned about what goes into a human regardless of the source. At the AABB Annual Meeting in Montreal this issue of non-human source was discussed and the assessors were told to assess all tissue if the control was under the medical director of service being assessed. This was quite a surprise because the responding colleague has been chair of her facility’s committee for "tissue issues" for years and until this past year they were only concerned with human products. She became Biovigilance Program Manager last July and created a Biological Product Supplier Qualification Questionnaire for Perioperative Services. She has found that Product/Prescriber Information (package inserts) must be reviewed and maintained to assess proper storage conditions. They have also purchased a web-based tracking application for allografts, implants and various biological products. They will expand to other areas of the hospital when they identify other biologics through purchasing. They have gained control of representatives bringing products in to "Dr X" to try as well as products brought in by "Dr X" from his home or office. She cautions that "sales representatives may tell prescribers that the product does not fall into Joint Commission jurisdiction but does require compliance with 21 CFR." However, 21 CFR Part 1271(cGTPs) states “compliance with parts 210,211, and 820 of this chapter. With respect to HCT/Ps… or under a biological product license application under section 351 of the Public Health Service Act”.

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