E.2.1.1. Access to the operating room
See generic requirements in section A.2.3.1.
See generic requirements in section A.2.3.2
The delay of recovery must be always as short as possible.
The maximum delay for the vascular tissue recovery in case of the non heart-beating donor is 24 hours with the condition that the warm ischemia time (delay between death and the beginning of cooling) is not longer than 6 hours.
The unique identification code of tissues and cells is attributed by the bank and should be based on national or European coding system
See generic requirements in section B.18.104.22.168.2.
The following particular specific aspects of the arterial and / or venous vessels to be recovered for vascular allograft preparation are:
a) Maintain the maximal length of the recovered vessel;
b) Collateral branches are cut at 2-3mm from the arterial wall. They may not be clipped cut by the metallic clips;
c) Avoid causing iatrogenic lesions during the manipulation; the veins during the stripping procedure may be accepted for allograft preparation with the condition they are meticulously examined.
For living donor: in the case of a patient undergoing a heart transplant, if the heart to be replaced has no valvular lesions, it can be recovered for valves.
See generic requirements in section A.2.3.3.
See generic requirements in section A.2.3.5.
The recovered tissues are placed in the crystalloid transport solution( e.g. NaCl 0.9%, Ringers lactate, HTK, Medium 199), with the possible addition of nutritional or osmotic elements (Betzler, Hank’s medium, albumin, …) and packaged separately in three sterile packaging layers (‘pouches’) after recovery. Each tissue / organ must be labelled and identified by a specific internal code.
This package is then placed in another container ensuring a temperature between +2°/+10°C and the protection of the recovered tissues during transport. It is essential that the container is closed correctly and is not opened again until its reception in the tissue establishment
Vessels and valves must be maintained at + 2/+10 ° C until the preparation phase, which should be carried out within 12 hours (maximum 24 hours) after the arrival at the bank. Tissues are prepared according to normal surgical procedures for isolation of the heart valves and vascular segments.
This package is then placed in the container which ensures the temperature between 0 and 4°C (filled with the wet ice) as well as the physical protection of the recovered material during transport. It is essential that the container is closed correctly and is not opened again until its reception in the tissues and cells bank, where it is to be processed.
See generic requirements in section A.2.3.7.