The safety of donor skin preserved with glycerol - Evaluating the Euro Skin Bank preservation procedures of human donor skin against the prEN 12442 standard
De veiligheid van donorhuid gepreserveerd met glycerol - Een evaluatie van de preservatieprocedures voor humane donorhuid van de Euro Skin Bank aan de hand van de prEN 12442 norm
26 May 2012, PDF |
75 pages |
Geertsma RE, Wassenaar C
RIVM Report 605148008
The procedures for preservation of human donor skin with glycerol, as applied by the Euro Skin Bank (ESB), were evaluated against the prEN 12442 standard: animal tissues and their derivatives used in the manufacture of medical devices. The focus chosen for this review is on risks related to the transmission of diseases. Product-related hazards were identified. Subsequently, the associated risks and the ESB measures to reduce these risks were discussed. The acceptability of the residual risks was also evaluated by comparing the risk-reducing measures with the prEN 12442, EN 1441, EN 1174 and ISO 14160 standards. Conclusions drawn indicate that ESB procedures as they now stand do not meet all the requirements of these standards. Nonconformities were used to formulate a validation plan containing considerations and suggestions on process definition and control, as well as an assessment of bacteriological and virological inactivation and/or elimination. The implementation of this plan should lead to full conformance with the standards.