Euro GTP Guidance - Euro GTPs

E.1.3.3.2.1.Anamnesis ...................................................................................................................................................148
E.1.3.3.2.2.Social evaluation..........................................................................................................................................148
E.1.3.3.2.3.Exclusion criteria..........................................................................................................................................148
E.1.3.3.2.4.Donor age ....................................................................................................................................................149
E.2. RECOVERY.............................................................................................................................................................. 149
E.2.1. ACTIVITIES ...................................................................................................................................................... 149
E.2.1.1. Access to the operating room ....................................................................................................................................149
E.2.1.2. Recovery.....................................................................................................................................................................149
E.2.1.2.1. Recovery.............................................................................................................................................................149
E.2.1.2.1.1. Donor identification....................................................................................................................................149
E.2.1.2.1.2. Gowning......................................................................................................................................................149
E.2.1.2.1.3. Donor preparation......................................................................................................................................149
E.2.1.2.1.4. Living Donors ..............................................................................................................................................150
E.2.1.3. Processing during recovery ........................................................................................................................................150
E.2.1.4. Quality control............................................................................................................................................................150
E.2.1.5. Packaging and labelling ..............................................................................................................................................150
E.2.1.6.1. Storage after tissue recovery..............................................................................................................................150
E.2.1.6.2.Transport after tissue recovery ...........................................................................................................................150
E.2.1.7. Documentation and release for processing................................................................................................................150
E.3. PROCESSING .......................................................................................................................................................... 151
E.3.1. ACTIVITIES ...................................................................................................................................................... 151
E.3.1.1. Reception ...................................................................................................................................................................151
E.3.1.2. Access to the processing facilities ..............................................................................................................................151
E.3.1.3. Processing...................................................................................................................................................................151
E.3.1.3.1.General................................................................................................................................................................151
E.3.1.3.2. Processing methods............................................................................................................................................151
E.3.1.3.2.1. Processing of tissues and cells ....................................................................................................................151
E.3.1.3.2.2. Decontamination of valves and vessels ......................................................................................................157
E.3.1.4. Quality control............................................................................................................................................................158
E.3.1.4.1. Microbiological control.......................................................................................................................................159
E.3.1.4.1.1. General principle ........................................................................................................................................159
E.3.1.4.1.2. Microbiological controls .............................................................................................................................159
E.3.1.4.1.3. Methods .....................................................................................................................................................159
E.3.1.4.2.Other controls .....................................................................................................................................................159
E.3.1.5. Packaging and labelling ..............................................................................................................................................159
E.3.1.6. Storage/ preservation ................................................................................................................................................159
E.3.1.6.1. General ...............................................................................................................................................................159
E.3.1.6.2. Methods of preservation and storage................................................................................................................160
E.3.1.6.2.1. Storage at +4°C ...........................................................................................................................................160
E.3.1.6.2.2. Cryopreservation and storage at ‐80°C.......................................................................................................160
E.3.1.6.2.3. Cryopreservation and storage in Liquid Nitrogen.......................................................................................160
E.3.1.6.3. Storage area .......................................................................................................................................................161
E.3.1.7. Documentation and release .......................................................................................................................................161
E.3.1.7.1. General ...............................................................................................................................................................161
E.3.1.7.2. Release ...............................................................................................................................................................161
E.3.1.7.3. Processing file contents......................................................................................................................................161
E.3.1.7.4. Availability for inspection ...................................................................................................................................161
E.3.1.7.5. Traceability .........................................................................................................................................................161
E.3.1.7.6. Archive................................................................................................................................................................161
SECTION F: SPECIFIC MUSCULOSKELETAL REQUIREMENTS...................................................................................... 162
F.1 DONOR SCREENING ................................................................................................................................................ 162
F.1.1. ACTIVITIES ...................................................................................................................................................... 162
F.1.1.1.Donor detection ..........................................................................................................................................................162
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