Übertragung von Prionen durch Arzneimittel und Medizinprodukte
Eine Risiko-Bewertung
Wissenschaft
Abstract
Transmission of Prions via Medicinal Product and Medical Devices – a Risk Assessment
The risk of transmitting prions, the infectious, causative agent of transmissible spongiform encephalopathy (TSE) via medicinal products and medical devices has to be assessed even when today the incidence of bovine spongiform encephalopathy (BSE) and variant Creutzfeldt-Jakob disease (vCJD) is decreased to minute levels. The exclusion of blood/plasma and organ/tissue donors based on pre-defined criteria and the traceability of all donations/donors has to be warranted to identify donations from donors based on post-donation information having contracted (v)CJD or are deceased due to (v)CJD to destroy such donations provided that they are not already processed further. A potential BSE contamination of products derived from cell cultures, especially the respective master/working cell banks and master/working virus banks, has to be estimated when the cell culture was propagated in the past with bovine serum. In general, it is required that all starting, raw, and auxiliary materials employed in the production of medicinal products and medical devices are categorised regarding different levels of prion load and the risk of prion transmission by the finished product has to be assessed. For these materials from ruminants, the risk assessment has to consider the number of prions in the tissue, organs or body fluids and, especially, the capacity of the production process of these materials to inactivate and/or remove prions.
Zusammenfassung
Das Risiko einer Übertragung von Prionen, dem infektiösen Agens übertragbarer spongiformer Enzephalopathien (Transmissible Spongiform Encephalopathy, TSE), durch Arzneimittel und Medizinprodukte auf Patienten ist zu bewerten, auch wenn heute die Inzidenz der Bovinen Spongiformen Enzephalopathie (BSE) und der variante Creutzfeldt-Jakob-Krankheit (vCJK) auf niedrigste Werte gesunken ist. Bei Blut-/Plasma- und Organ-/Gewebespendern sind Kriterien des Spender-Ausschlusses zu berücksichtigen sowie eine vollständige Rückverfolgung aller Spenden, um Spender, die möglicherweise nach der Spende an vCJK
