D.2.1.1. Access to the operating room
See generic requirements in section A.4.1.1.
See generic requirements in section A.220.127.116.11.
The recovery procedures are such that the properties of the tissues, which are important for the ultimate clinical use, are preserved and that microbiological contamination is avoided as far as possible during the process
See generic requirements in section A.18.104.22.168
See generic requirements in section A.4.
The skin is removed making use of aseptic techniques. Before recovery, the skin should be treated with a suitable anti-bacterial agent. When selecting this agent a reasonable compromise must be found between loss of viability (viability is important in certain clinical applications) and the efficiency of the decontamination process.
Partial thickness skin can be taken of using a dermatome that can be adjusted to the appropriate thickness in such way intact skin is recovered. Thickness may range from 0.2 mm- 1.0 mm. Full thickness skin can be recovered using a scalpel.
For aesthetic reasons and with a view to a respectful reconstruction of the donor, it is not acceptable to take skin from the neck, face and other places which would be visible when people pay their last respects to the donor.
Bearing in mind that (partial) removal of skin is always accompanied by a considerable loss of fluid over time, the necessary measures should be taken to prevent this loss or else ensure this is not noticeable when people are paying their last respects to the donor.
Pre-processing samples for microbiology tests can be taken, depending on the type of processing method.
See generic requirements in section A.4.1.5.
The recovered skin is transferred to sterile container (s). After closure, a label with the unique donor identification number indicating that the tissue is not released for transplantation.
See generic requirements in section A.4.1.6.
Recovered skin must be transported in a suitable medium. This transport medium may contain one or more antibiotics so that immediately after recovery microbial inactivation can be started with (at the point recovery takes place the skin is not sterile). When making the choice of a transport medium, the choice of antibiotics and temperature at which the skin will be transported, a reasonable compromise should be found between the loss of function, viability (viability is important in certain clinical applications) and the efficacy of the decontamination. The transport should be validated and should not cause the skin to become clinically ineffective or harmful for the recipient. Should microbial inactivation be implemented then this procedure should be specified (in the standard practice conditions of the skin bank), documented, validated and be reported to the surgeon carrying out the transplantation.
Upon receipt of the container containing the donor material, checks will be carried out to establish if any leakage has occurred during transportation or whether any damage or breakage has been suffered by the container and/or if the seal of the top has been broken. The refrigeration process must at no time be interrupted, depending on the requirements of the processing method that will be used for the skin. In addition the labels will be examined to see if they are intact and legible. Each of the above mentioned situations would provide reason for the tissue being rejected.
See generic requirements in section A.4.1.7