Guidance Document - American Association of Tissue Banks

accepted. Returning establishment should follow the instructions from the tissuebank from which the allograft was received.Q12.Tissue manufacturers often request that a Distribution Intermediary returndamaged tissue (allografts) to them for destruction. This allows themanufacturer to inspect the tissue and determine final disposition. Whattype of record, if any, is a Distribution Intermediary required to maintain forthis type of transfer?A12. The Distribution Intermediary should maintain a distribution record, whichdemonstrates when tissue was returned to the manufacturer per manufacturer’sinstruction and the reason for the return.Q13. What are the requirements for tissue transport by a DistributionIntermediary, such as an independent sales representative?A13. Distribution Intermediaries must store tissues at the storage temperatures (or otherparameters) established by the tissue manufacturer. Storage outside theestablished storage requirements may adversely affect contamination control.Tissues must be shipped or transported at the shipping conditions defined by theprocessor.Q14. What type of package inserts should be shipped with tissue?A14. Package inserts may vary with each tissue type. Package inserts may include areturn policy (if one exists), tissue transplant record/implant card (to track tissuedisposition), instructions for use and storage, indications for use, any claims made,instructions for adverse event reporting, tissue description, an expiration date (ifapplicable), and any warnings or warranties, if applicable.Q15. What should I do if I discover that a tissue graft is mislabeled?A15. Each establishment should develop a written procedure for handling mislabeledtissues. The procedure should include evaluation of the mislabeling severity,assessment of risk to patients, and disposition of the mislabeled tissue.Q16. Who is responsible for the handling of tissues during shipment?A16. The carrier designated for the shipment of the allograft assumes the responsibilityof the package during shipment. Shipping containers selected should be of properconstruction and design for the purpose for which they are used. If tissues aretransported by a Distribution Intermediary, such as an independent salesrepresentative, the Distribution Intermediary assumes responsibility for tissueduring transport and delivery and must follow instructions provided.Page 38 of 44