Tuesday, September 19, 2017
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Musculoskeletal tissue donors are usually deceased donors.  There can be also explanted musculoskeletal tissues, e.g. femoral head accepted for donation from living donors.

 

F.1.1.1.Donor detection

See generic requirements in section A.3.1.1

F.1.1.2.Donor consent

See generic requirements in section A.3.1.2

F.1.1.3. Donor evaluation

F.1.1.3.1.General

1.The suitability of a specific individual for musculoskeletal tissue donation should be documented and should be based on medical and social history, clinical status, physical assessment, testing and autopsy (if performed) according to the generic EU GTPs (see generic requirements in section A.1.).

F.1.1.3.2. Medical evaluation

See generic requirements in section A.3.1.6.

F.1.3.3.2.1. Anamnesis

See generic requirements in section A.3.1.6

F.1.3.3.2.2. Social evaluation

See generic requirements in section A.3.1.6.3

F.1.3.3.2.3. Physical evaluation

1. All prospective musculoskeletal tissue donors should undergo a thorough physical examination as close as possible prior to donation with special attention to physical signs of HIV disease, infectious hepatitis, and injecting illegal drug use (see generic requirements in section A.3.1.6.4).

F.1.3.3.2.4. Exclusion criteria

1. The selection criteria for musculoskeletal tissue donors are based on a risk analysis in relation to the use of the donor tissue. Indications for such risks are to be identified with the help of anamnesis, appropriate sources such as donor's medical files and consultation of treating physicians, biological testing, post mortem examination, and other suitable examinations, e.g. autopsy results.  Unless the donation is justifiable based on a documented risk evaluation performed by the responsible person, donors are to be excluded from donating, if one or more of the exclusion criteria should apply.

2. Below is presented the MINIMUM set of contraindications for use of different musculoskeletal tissue for transplant purposes. Individual musculoskeletal banks may have additional exclusionary criteria.  Some criteria listed as generally exclusionary may be acceptable depending on the storage method used for tissue preservation.

F.1.3.3.2.4.1.Exclusion criteria musculoskeletal tissue donors

1. In addition to the exclusion criteria mentioned section A.3.1.6.5. of the generic GTP requirements, screening of musculoskeletal tissue donors should be conducted for the following disorders and age limits:

a)                  Bone, cartilage, osteoarticular grafts, tendons, meniscus, and fascia lata:

                          i.       history of osteo-arthritis,

                        ii.       metabolic bone diseases (osteoporosis, osteopetrosis, Paget’s disease, etc...),

                       iii.       suicide by ingesting cyanide or heavy metals (mercury, gold, etc..),

b)                  Cartilage and osteoarticular grafts additionally:

                          i.         iatrogenic or degenerative lesions detected during retrieval

c)                  Meniscus additionally:

                          i.                  iatrogenic or degenerative meniscus tears detected during retrieval

d)                  Tendons additionally:

                          i.       iatrogenic or degenerative tendon tears detected during retrieval

2. Musculoskeletal tissue retrieval from deceased donors should occur as soon as possible after death, however no later than forty eight (48) hours post mortem if 12 hours after death body was cooled otherwise retrieval should occur no later than 24 hours after death. All time intervals for each donor (death to enucleation and preservation) should be recorded.

 

 

F.1.3.3.2.4.1.3. Infections

Persons with significant local bacterial, viral, parasitic or mycotic infection including cannot be considered as musculoskeletal tissue donors.

F.1.3.3.2.4.1.4. Invalid laboratory test results

Tissue banks may only accept tissue from donors with a plasma dilution of more than fifty (50) per cent, if the test methods applied to such plasma are validated.

F.1.3.3.2.4.1.5. Vaccination

Persons who received a post expositional vaccination against rabies within the last twelve (12) months or a live vaccination, e.g. against poliomyelitis, yellow fever, rubella, measles, mumps, within the last four (4) weeks prior to removal of the cornea cannot be considered as donors.

F.1.3.3.2.4.1.6. Donor age

Donor age limit differs in different kind of musculoskeletal tissues. Age limits are as follows:

a)                 for bone minimum age: 15 years for both sexes;

b)                for  tendons and fascia lata: 15-65 years for both sexes;

c)                 for osteo-articular, cartilage, meniscus: 15-45 years for both sexes;

d)                for chondrocytes culture : 15-55 years for both sexes.

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