Tuesday, August 22, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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F.2.1.1. Access to the operating room or other recovery room

See generic requirements in section A.4.1.1.

F.2.1.1.1. General

See generic requirements in section A.4.1.3.1.

F.2.1.1.2. Deceased donors

The entire retrieval of the musculoskeletal donor is to be performed like during autopsy. Tissue recovery is to be performed using validated aseptic procedures.

F.2.1.1.2.1. Donor identification

Prior to tissue recovery, the donor should be positively identified by cross-check with a tag or other label on the body, or by positive identification by hospital or mortuary staff.

F.2.1.1.2.2. Gowning

Staff performing the retrieval is to be dressed appropriately for the kind of retrieval to minimize the risk of contamination of the tissue to be removed and also the hazard for the performing staff.  This includes due disinfection (surgical hand disinfection), sterile clothes as well as to wear sterile gloves, face mask or protective mask and surgery cap.

F.2.1.1.2.3. Donor preparation

The donor skin should be cleaned using a suitable disinfectant (e.g. PVD iodine), a local sterile area should be created in the area of retrieval using sterile cloths.

F.2.1.1.2.4. Procurement of long bones of the lower limb

A skin incision begun from the anterior superior iliac process extending over the greater trochanter, distally along the lateral thigh towards the anterior knee over the patellar tendon and extended distally over the anterior tibial crest up to the ankle.

F.2.1.1.2.4.1. Procurement of the femur

Fascisa lata must be incised, surrounding muscles are to be dissected and femur must be disarticulated at the knee level. In the next stage the hip abductors must be released and the thigh muscles elevated.  The femur than, must be internally rotated and the hip capsule incised close to the acetabulum.  The femur may be removed.

F.2.1.1.2.4.2. Procurement of the tibia and the fibula

Muscles must be elevated laterally and medially.  The inter-osseous membrane must be incised close to the tibia.  The proximal and distal tibio-fibular joints must be disarticulated. The tibia and fibula may be removed.

F.2.1.1.2.5. Procurement of the iliac crest or hemipelvis

To recover the iliac crest, the incision described in F.2.3.2.2.4. must be extended from the anterior superior iliac process posteriorly.  Soft tissues must be removed and after the sacroiliac joint and the symphysis pubis disarticulation the piece of iliac crest or hemipelvis may be removed.  If bowel perforation occurs, harvesting of the pelvis should be terminated.

F.2.1.1.2.6. Procurement of long bones of the upper limb

A skin incision begun at the coracoid process, extending along the deltopectoral groove, then extending along the anterolateral aspect of the arm to the elbow, then distally along the radial aspect of the forearm. 

F.2.1.1.2.6.1. Procurement of the humerus

The rotator cuff must be transected at musculotendinous junction, leaving the tendinous portion attached to the proximal humerus.  The humerus must be disarticulated at the arm and elbow levels. The humerus may be removed.

F.2.1.1.2.7. Procurement of the rib

Incisions must be made directly over the ribs extending from the costal margins to the posterior vertebral attachment.  Surrounding intervertebral muscles must be dissected, disarticulation at the costo-vertebral joint and the sternum must be made. The rib may be removed. 

F.2.1.1.2.8. Procurement of the fascia lata

Fascia lata is excised before removal of the femur as described in F.2.3.2.2.4.1.

F.2.1.1.2.9. Procurement of Achilles tendon

The Achilles tendon may be recovered during procurement of the tibia and the fibula (see F.2.1.2.2.4.2.) together with an attached bone block from the calcaneus.

F.2.1.1.2.10. Procurement of the patellar tendon

The patellar tendon should be removed with a block of tibial tubercle distally and the patella proximally using the anterior incision over the knee joint and quadriceps muscles.  The soft tissues must be cleared approximately 12 cm above and below the joint line. The femur and tibia-fibula must be osteotomised. Patellar tendon may be procured during or during procurement of long bones of the lower limb (F.2.1.2.2.4.).

F.2.1.1.2.10. Procurement of the menisci

The menisci are usually left attached to the tibia and can be procured after tibia removal from the donor.

F.2.1.1.2.11. Reconstruction of the donor’s body after procurement

A wooden stick or a plastic bone approximating the size of the donor bone may be used to replace the procured bone.  The split muscles should be resutured using surgical sutures followed by subcutaneous tissue and skin. The natural anatomic contours of the body must be restored.

F.2.1.2.3. Living donors

Musculoskeletal tissues can be procured from living donors.

F.2.1.2.3.1. Living allogenic donors
F.2.1.2.3.1.1 Femoral head donors

Patients subjected to surgical procedure of hip replacement can be considered as living donors of femoral heads. Removed bone fragment that is replaced by prosthesis can be donated.

F.2.1.2.3.2. Living autogenic donors

F.2.1.2.3.2.1. Cranial flap

Cranial flaps removed during neurosurgical procedures can be donated for autologus grafting when it is impossible to place the craniotomy flap due to the brain oedema.

F.2.1.2.3.2.2. Cartillage for chondrocyte culture

Cartillage fragment from the unloaded part of the knee joint cartilage may be procured during surgical procedure (e.g. knee arthroscopy)

F.2.1.3. Processing during recovery

See generic requirements in section A.4.1.4.

F.2.1.4. Quality control

See generic requirements in section A.5.1.4.

F.2.1.5. Packaging and labelling

See generic requirements in section A.4.1.5.

F.2.1.5.1. Primary packaging and labelling

Subsequently to retrieval the obtained musculoskeletal tissues are to be packaged in a way to minimize the contamination risk. Each procured tissue is to be packed separately and labelled immediately after recovery

F.2.1.5.1.1 Packaging for hypothermic storage

Musculoskeletal tissues are to be at least double packed in air tight foil packages.

F.2.1.5.1.2. Packaging for cell culture

For packaging of cartilage biopsy tissue banks should use a sterile, sealable container containing appropriate normothermic chondrocyte transport medium in accordance with manufacturer’s recommendations.  An established medium for that purpose might be PBS (phosphate buffer saline) and DMEM-F12 culture medium with or without FBS (foetal bovine serum).

F.2.1.6. Storage and transport after recovery

See generic requirements in section A.4.1.6.

F.2.1.6.1. Storage after tissue recovery
F.2.1.6.1.1. Storage temperatures

The procured musculoskeletal tissues are to be stored at temperatures appropriate to maintain their characteristics and biological functions suitable for the intended use.  These temperatures principally correspond to the storage temperatures specified below in dependence of the method.

-        The musculoskeletal donor tissues should be stored at hypotermic conditions.  Storage temperatures according to validated protocol should be 2-8oC or in temperatures from-30 to -70°C (on dry ice, in freezers or deep-freezers).  It is also accepted to store musculoskeletal tissues in liquid nitrogen containers at temperatures between -75ºC to - 196ºC.

-        The cartilage for chondrocyte culture should be stored at 4 to 8 ºC in the refrigerator.

F.2.1.6.1.2. Storage time
F.2.1.6.1.2.1. Storage time for hypotermic storage

A storage period should be evaluated and validated.  Usual storage period do not exceed 3 months after procurement.

F.2.1.6.1.2.2. Storage time for cell culture

A storage period should be evaluated and validated.  Usual storage period do not exceed 3 days.

F.2.1.6.2.Transport after tissue recovery

Musculoskeletal donor tissues are to be transported at appropriate temperatures to maintain their characteristics and biological functions.  Principally these temperatures correspond to the storage temperatures (see chapter F.2.3.6.1.), depending on the tissue and the method of cultivation.

The package and the mode of transport are to be chosen in a way to ensure maintenance of the tissue specific storage temperatures (see chapter B.2.3.6.1).  This is to be monitored by the tissue bank in regular intervals.  If temperature stability should not be reliably guaranteed by the pack or mode of transport used also in cases of unexpectedly high or low environmental temperatures, a temperature recording unit is to be enclosed that is to measure the temperature inside the pack in minimally half-hour intervals and save the data.  In addition, the pack is to prevent contamination by persons in charge of tissue packaging and transport.

The transport time of donor cartilage for chondrocytes culture should be kept as short as possible.

F.2.1.7. Documentation and release for processing

See generic requirements in section A.4.1.7. 

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