Refrigeration devices containing tissue shall be suitable for the use intended and procedures for monitoring such devices shall be validated so that tissues are maintained at the required storage temperature. Continuous monitoring and recording of temperature, together with suitable alarm systems, shall be employed on all storage refrigerators, freezers and liquid nitrogen tanks.
Every effort should be made to avoid cross-contamination of material stored in liquid nitrogen vessels. Wherever possible, there should be specifically designated pieces of equipment (e.g. nitrogen level rulers, portable thermometers) for each vessel. Where this is not possible (e.g. liquid nitrogen delivery hoses) and the item has to be used for more than one vessel, it should not come into contact with the liquid phase or the sides of the vessel.
Frozen and cryopreserved tissue should be double wrapped during storage. The seals and the material employed must be validated for their use at the designated storage temperature and the conditions of use, to demonstrate integrity of the packaging and labelling. This is crucially important for storage in liquid nitrogen vessels because of the high levels of accumulated microbial contaminants found within these vessels.
Quarantined and released tissue must be stored in physically segregated, clearly designated locations distinct from each other.
Prior to any tissue being cleared for issue, all relevant records including donor records, processing and storage records, and post-processing quality control test results must have been reviewed, approved and documented as acceptable by the individual(s) responsible according to the relevant local standard operating procedures. Responsibilities for setting policies for exceptional release of tissues reside with the designated medical officer.
There must be a documented policy for the discard of tissue unsuitable for clinical use. Records should include details of date and method of discard and reason for discard. Tissues for discard should be appropriately handled and disposed of in a manner compliant with local control of infection guidelines.
Packaging must ensure integrity and maintain sterility of the contents of the final container, and must also comply with current legislation.
The container must be labelled with the graft-specific identification (batch and shipment number if applicable), expiry date and supplying tissue bank, storage instructions and barcoded product description and instruction to see pack insert, as a minimum. In addition, more detailed information should be provided either on the label or package insert or both as follows:
For transport, the primary container must be placed in a shipping container that must be labelled with at least the following information:
All reasonable efforts must be made to ensure that tissues are sent to qualified individuals/organisations who have accepted responsibility for their proper handling and use. A written agreement must be in place between the Tissue Establishment and the organisation ordering the tissue.
Where tissue is transported in a refrigerated or frozen condition, adequate safeguards should be taken to ensure that the tissue remains at the designated temperature. Monitoring of temperature should be undertaken wherever practicable but if not, the method should at least have been validated to show that appropriate temperatures are maintained.