Change of measures in dealing with donors
Section 6(2)(34) of the Blood Donor Ordinance (BSV1) currently requires that, based on medical assessment, persons who have been in West Nile virus endemic areas must be excluded from collection for 28 days after leaving the West Nile virus endemic area in accordance with section 6(3) to (5) of the BSV for the specified period.
This procedure is also to be applied to dengue virus or other regionally restricted pathogens of infectious diseases with a similarly long incubation period.With regard to tissues and cells, similar safety criteria are to be applied, which are generally formulated in the Tissue Collection Establishment Ordinance - GEEVO2): § 3 Abs 2 Z 4: "Systemic infection that is not under control at the time of donation, including bacterial infections, systemic viral, fungal or parasitic infections, or [....]" and § 3 para 2 line 8: "signs of other risk factors for infectious diseases based on a risk assessment, taking into account the donor's travel and exposure history and the local prevalence of infectious diseases, [...]".Information on regional outbreaks of the above diseases can be obtained from the European Centre for Disease Prevention and Control(ECDC), the Center for Disease Control and Prevention(CDC), and the World Health Organization(WHO).All previously issued instructions are superseded by this requirement.Appropriate consideration in medical history interviews and donor selections is therefore requested.
- Ordinance of the Federal Minister of Labor, Health and Social Affairs concerning the health protection of donors and the quality assurance of blood and blood components Federal Law Gazette II No. 100/1999, amendment as amended: Federal Law Gazette II No. 188/2005 [CELEX No.: 32002L0098, 32004L0033], Federal Law Gazette II No. 217/2008
- Ordinance of the Federal Minister for Health, Family and Youth laying down standards for the collection of human cells and tissues intended for human use Ordinance of the Federal Minister for Health, Family and Youth laying down standards for the collection of human cells and tissues intended for human use Federal Law Gazette II No. 191/2008 [CELEX No.: 32006L0017] .
Queries:
Institute Inspections, Medical Devices & Hemovigilance
Andreas Krassnigg, M.D.
E-mail: inspektionen@ages.at
Tel.: +43 (0) 50 555-36410
