Friday, July 21, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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D.1.1. ACTIVITIES

D.1.1.1.Donor detection

See generic requirements in section A.3.1.1.

D.1.1.2.Donor consent

See generic requirements in section A.3.1.2.

Before medical screening and removal of tissue, informed consent must be obtained from the donor or family.

The family of the donor must be informed of the following:

a)     Use of the tissue, for therapy or for research, for further processing into ATMPs;

b)    The possibility to be informed of the results of the screening (e.g. serology test results);

c)     The possibility to be informed the tissue was transplanted or not;

d)    Medical confidentiality;

e)     The use of personal data.

 

D.1.1.3. Donor evaluation

D.1.1.3.1.General

See generic requirements in section A.3.1.6.1.

D.1.1.3.2. Medical evaluation

Background for personnel responsible for final donor acceptance: medical doctor.

First screenings: trained nurses as minimum.

The TE must have a procedure to update the selection criteria.

Annual review of the donor selection criteria, review of the literature, state of the art (scientific) this can also be in the Generic GTP.

Skin allografts are generally obtained from non-living donors (heart-beating or non-heart-beating donor).

The use of skin allografts for children obtained from their parents and family members is not undertaken.  This practice does not necessarily increase the bio-security and results in an unnecessary medical risk with regard to the donor as well as an unnecessary cost to society.

D.1.1.3.2.1.Anamnesis

See generic requirements in section A.3.1.6.

D.1.1.3.2.2.Social evaluation

See generic requirements in section A.3.1.6.3

D.1.1.3.2.3. Physical evaluation

The donor must be inspected before starting the recovery to check the above described contra-indications.  The results must be recorded and taken into account in the final release procedure of the tissue.

D.1.1.3.2.4. Exclusion criteria

The list of selection criteria for donors is based on a risk analysis related to the use of the tissue on patients; i.e. to minimize the risk of transfer of diseases for the recipient and to ensure the appropriate quality of the skin for optimal functional results.

Contra-indications specific for skin:

a)     Systemic corticoids > 20 mg/day prednisolone or equivalent for more than one episode of > 3 weeks in the past 2 years;

b)    Auto-immune dermatoses;

c)     Systemic connective tissue diseases;

d)    Diseases affecting the dermis (dermal mucinosis, nephrogenic fibrosing dermopathy, porphyria);

e)     Mechanical or microbial damage to the skin;

f)     Burns at the location on the body to be recovered;

g)     Toxicity of the skin as a result of the presence of toxic agents or poisons;

h)    Presence of possible melanomas;

i)      Systemic infections which at the time of donation are not under control.

Relative contra-indications for skin, to be decided per donor case:

a)     Extensive laceration or scars;

b)    Skin diseases with extensive involvement, such as psoriasis, eczema, nodules, decubitus, ulceration, pyoderma, mycoses;

c)     Skin disorders interfering with recovery or aesthetically not acceptable for patient treatment such as extensive tattoos;

d)    Long lasting alcohol abuse with complications such as liver cirrhosis;

e)     Diabetes for > 10 years with complications;

f)     Skin disorders interfering with recovery or aesthetically not acceptable for patient treatment such as extensive tattoos;

g)     Long lasting alcohol abuse with complications such as liver cirrhosis;

h)    Diabetes for > 10 years with complications.

Age limits: Minimum: 18 - Maximum: none

D.1.1.3.2.5. Post Morten Time

Maximum period of time permitted before recovery of the tissue.

The skin should be procured as quickly as possible after death.  Should the donor not be refrigerated after dying, then recovery should be completed within 12 hours of death.  Should the donor be refrigerated within six hours of dying, then the recovery of the skin should be completed within 48 hours of death.  In this case, blood samples for laboratory screening should be collected and processed within 24 hours of death.  Pre-mortem blood samples can also be used, when available.  It is recommended, however, that even when refrigeration has been implemented recovery should be started within 24 hours of the donor’s death.

Blood tubes should be centrifuged as soon as possible after withdrawal to separate the cells from the serum or plasma so as to avoid false positive or negative results.  It is advisable to use tubes with a gel clot.  If possible, the tubes should be centrifuged at the recovery site to check the quality of the samples immediately so another sample can be drawn or pre-mortem samples can be obtained from the hospital laboratory.

D.1.1.3.2.6. Laboratory test results

Blood samples must be taken just prior to death or within 24h after death.

a)     HIV 1 and 2

b)    HCV

c)     HBV (HbsAg and anti-HBc

d)    HTLV II/I for donors from areas with high incidence

e)     TPHA

f)     For HIV and HCV: NAT testing

In case the information is needed:

a)     ABO group;

b)    Rhesus factor;

c)     Result of CMV serology; 

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