The safety of donor skin preserved with glycerol - Evaluating the Euro Skin Bank preservation procedures of human donor skin against the prEN 12442 standard
Geertsma RE Wassenaar C
Geertsma RE
Wassenaar C
Citations
Altmetric:
Series / Report no.
Open Access
Type
Report
Language
en
Date of publication
2000-08-31
Year of publication
Research Projects
Organizational Units
Journal Issue
Title
The safety of donor skin preserved with glycerol -
Evaluating the Euro Skin Bank preservation procedures of human donor skin
against the prEN 12442 standard
Translated Title
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
Published in
Abstract
De procedures voor de preservatie van humane donorhuid
zoals die worden toegepast door de Euro Skin Bank (ESB) zijn geevalueerd met
behulp van de Europese standaard prEN 12442: "Dierlijke weefsels en daarvan
afgeleide producten die voor de vervaardiging van medische hulpmiddelen
worden gebruikt". Dit overzicht heeft zich gericht op de risico's
betreffende de overdracht van ziekte. Eerst werden productgerelateerde
gevaren geidentificeerd en vervolgens werden de hieraan verbonden risico's
en de beheersmaatregelen hiervoor van de ESB besproken. Verder werd
geevalueerd of de overblijvende risico's accepteerbaar zijn door de
risicoverlagende maatregelen te vergelijken met de eisen in de volgende
standaarden: prEN 12442, EN 1441, EN 1174 en ISO 14160. De conclusies geven
aan dat de ESB-procedures op dit moment niet aan alle eisen van deze
standaarden voldoen. Met behulp van de geconstateerde tekortkomingen is
vervolgens een validatieplan opgesteld, dat overwegingen en suggesties ten
aanzien van proces-definitie en -beheersing en de beoordeling van
bacteriologische en virologische inactivatie en/of eliminatie bevat.
Implementatie van dit plan zou ertoe moeten leiden dat de procedures
volledig aan de standaarden gaan voldoen.
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.
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.
Description
Publisher
Sponsors
IGZ
GMV