EFHSS Questions and Answers - Question Q00126

Is there any report on the liklihood of medical devices being contaminated with TSE agents (prions) during manufacture? Would this be more likely if TSE diseases eg BSE were endemic in a country. Is this a risk? How would a device be decontaminated as sterilisation is less than effective with TSE agents?
Peter Fernie

Dear Peter,

It looks highly unlikely that medical devices could be contaminated with prions during the production process, in whatever country this might take place (I am not aware of any reported case).
For medicinal products the "Note for Guidance on Minimising the Risk of Transmitting Animal Spongiloform Encephalopathy via Medicinal Products", referred to in the annex to Directive 75/318/EEC as amended by Directive 1999/82/EEC concerning TSE, is in force from 1 January 2001. This resolution changes method 5.2.8. of the Europeian Pharmacopeia.
There must be proven now that substances, if they are of bovine origin, are safe in the field of TSE. This proof is delivered by submitting of a "TSE certificate of suitability" of the European Directorate for the Quality of medicines (EDQM) or by submitting scientific data.
I may suppose that manufacturers of medical devices, if they should use materials of bovine origin, also meet the same requirements in their GMP, ISO or quality assurance programms.
For the decontamination protocol I refer you to question Q00029 (see also questions Q00005 and Q00002). The lecture of the article about: "Iatrogenic vCJD from surgical instruments" in the latest issue of the ISSM Journal, January-March 2002, Vol.6 No.3 (publications page) is also recommended.

Kind regards,
Wim Renders

PS:
The ASTER website is removed to our Related Sites and Links page, see there under Belgium.