All of the essential data for tissue that is used as an allograft or transplant must be recorded. This can provide crucial data if a problem should occur. As the US FDA further regulates transplanted tissues the data requirements are likely to increase.


Reasons for tracking:

(1) infection in donor (HIV, viral hepatitis, Creutzfeldt-Jakob disease)

(2) infection in recipient due to contamination

(3) toxic contamination of tissue

(4) metabolic disorder in donor

(5) immune reaction due to error in labeling


Data to record:

(1) name of the tissue bank that is the source

(2) donor identification number

(3) recipient identification number

(4) collection date

(5) transport dates

(6) receipt date

(7) final disposition date

(8) nature of final disposition (placement in donor, cremation, etc.)

(9) details of final disposition (if used in patient)

(10) name of surgeon performing operation

(11) data on relevant infectious disease testing

(12) data on storage conditions

(13) data on transport conditions

(14) data on any special processing

(15) data on any exceptions


This data needs to be maintained indefinitely.


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