Traduction de «Exposition au sang et aux dérivés sanguins » (Français → Anglais) :

We know that some medical procedures present a higher risk of DEHP exposure, such as multiple transfusions of blood products and extracorporeal oxygenation in newborns, pregnant women or nursing mothers, multiple transfusions of blood products in general and also heart transplants or cardiopulmonary bypass procedures.

Blood and blood components imported from third countries, including those used as starting material or raw material for the manufacture of medicinal products derived from human blood and human plasma intended for distribution in the Community, should meet equivalent Community standards and specifications relating to a quality system for blood establishments as set out in this Directive.

Accordingly, blood and blood components imported from third countries, including those used as starting material or raw material for the manufacture of medicinal products derived from human blood and human plasma, intended for distribution in the Community, should meet equivalent Community standards and specifications relating to traceability and serious adverse reaction and serious adverse event notification requirements as set out in this Directive.

The application of the provisions on medical devices incorporating stable derivates of human blood or human plasma includes application of Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (10).

2. A Belgian law provides that blood products and blood placed on the Belgian market may come only from unpaid donors.

BLOOD SAFETY AND SELF-SUFFICIENCY - COUNCIL RESOLUTION "THE COUNCIL OF THE EUROPEAN UNION, RECALLING the Commission communication of 25 May 1993 on blood self- sufficiency in the European Community and its conclusions of 13 December 1993 on that communication; NOTES with interest the Commission communication of 21 December 1994 on blood safety and self-sufficiency in the European Community; REAFFIRMS the need to achieve self-sufficiency in blood and its derivatives in the Member States and in the Community, in particular through cooperation between Member States, in accordance with the principle of voluntary, unpaid blood donations; EMPHASIZES that the efforts to promote the quality and safety of blood collection help to prevent AIDS and ...[+++] other communicable diseases; RECALLS that Directive 89/381/EEC [1] which extends the scope of Directives 65/65/EEC and 75/319/EEC on proprietary medicinal products by laying down special provisions regarding medicines derived from human blood or plasma applies only to these products; AGREES on the need to define a strategy for reinforcing trust in the safety of the blood-transfusion chain and promoting self-sufficiency in the Community; ACCORDINGLY AGREES that, taking full account of the Council of Europe's discussions, the main activities to be undertaken could include: - the development of policies and agreed procedures in the donor-selection process among blood-collection establishments; - the implementation of efficient, validated and reliable screening tests; - the development and use of quality-assessment criteria and good practices regarding the collection, processing and transfusion of blood and blood products and patient follow-up procedures; - development of a haemovigilance system on the basis of existing networks for the collection of epidemiological data related to the blood- transfusion chain; - encouragement of health professionals to make optimal use of blood and blood products; - the establishment of basi ...