Tuesday, September 19, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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C.1.1. ACTIVITIES

C.1.1.1.Donor detection

See generic requirements in section A.3.1.1

C.1.1.2.Donor consent

See generic requirements in section A.3.1.2.

C.1.1.3. Donor evaluation

C.1.1.3.1. General

The suitability of a specific individual for placental tissue donation should be documented and should be based on medical and social history, clinical status, physical assessment, and testing according to the generic EU GTPs (see generic requirements in section A.1.3.3.).

C.1.1.3.2. Medical evaluation

See generic requirements in section A.3.1.6.

Additionally, amniotic membrane can only be retrieved, if the donor has had a caesarean section as well as in the absence of a known infection of the physiologically almost sterile abdominal cavity or even systemic infections (sepsis).  Physical evaluation is not relevant for amniotic membrane donors.

C.1.1.3.2.1. Exclusion criteria

The selection criteria for amniotic membrane donors are based on a risk analysis in relation to the use of the donor amniotic membrane.  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, and other suitable examinations.  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.

In addition to the exclusion criteria mentioned in A.3.1.6.5., screening of amniotic membrane donors should be conducted for at least the following disorders, which are potentially health threatening for the recipient(s) or pose a risk to the success of the surgery, and should not be offered for surgical purposes:

Pathologies of the female genital tract or other diseases of the donor or unborn child that might be a hazard to the recipient’s safety include:

a)     Significant local bacterial, viral, paracital or mycotic infection of the genital tract, especially amniotic infection syndrome;

b)    Gestational diabetes of the donor;

c)     (Known) malformation of the unborn / newborn;

d)    Premature rupture of membranes.

Individual tissue banks may have additional exclusionary criteria.

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