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Call for interested parties regarding apheresis connector harmonisation

Brussels, 8 February 2012 – EBA, the European Blood Alliance, and Eucomed, the European medical technology industry association, are calling all stakeholders involved in the design, development and manufacturing of medical devices used for apheresis systems and associated solutions to participate in the project aimed at designing a new connector specific for apheresis.

A meeting held in Lisbon in the summer of 2011 brought together Blood Establishments from around the world, the European Commission, Competent Authorities, the FDA and the medical technology industry to discuss the potential risks associated with the erroneous use of medical devices used for apheresis procedures in donors and patients, and to agree on a harmonised solution for apheresis connectors applicable at an international level. Apheresis is a method by which one or more blood components are obtained through machine processing of whole blood while the remaining components are returned to the donor or patient.

The participants to the meeting acknowledged the value of cooperating at a global level to develop a new connector specific for apheresis systems which will guarantee the highest level of safety for donors and patients and prevent future reversed line connections which can result in severe injury, including death.

The intention is for the outcome of this project to feed into a future global standard.

Design innovators are now ready to present prototypes to interested parties and in collaboration, Eucomed and EBA are inviting you to participate in a WebEx session.  During this session, you will have the opportunity to receive an update on this project, give feedback on the designs and provide input for a tentative meeting proposed on 21st March in Brussels with end users (mainly Blood Establishments) to present the prototypes.  The WebEx session is scheduled to take place on 13th February from 14.30 to 16.00h GMT.  We appreciate this is very short notice and are happy to provide interested stakeholders who cannot participate in the WebEx with the outcome of the WebEx including next steps.  CaridianBCT, together with  third party manufacturer Technoflex, have taken the lead on this project and are inviting all interested participants to contact the following person for the WebEx login and more details regarding the project and the meeting:

Laura DeNuccio, CaridianBCT

Direct: + 303.239.2166
Cell: + 720.206.6242
Email: laura.denuccio@caridianbct.com

Download the June 2011 press release“Stakeholders join forces to increase safety in the blood transfusion chain

About EBA

The European Blood Alliance (EBA) is an association of not for profit Blood Establishments, with 23 members throughout the European Union and EFTA States. The mission of the European Blood Alliance is to contribute to the safety, security and cost effectiveness of the blood and tissue and cell supply for the citizens of the Europe by developing and maintaining an efficient and strong collaboration amongst European blood and tissue services. EBA aims to increase public and professional awareness of voluntary and non-remunerated donation (VNRD) of blood and blood components, as the basis for preparation of blood components as an indispensable therapeutic means to save patients and to assist European blood establishments to continuously improve their performance based on scientific and ethical principles for the benefit of patients. For more information visit: www.europeanbloodalliance.eu

About Eucomed

Eucomed is the European medical technology industry association. Its mission is to make modern, innovative and reliable medical technology available to more people. Eucomed represents directly and indirectly 22,500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. Small and medium sized companies make up more than 80% of this sector. The European medical technology industry generates annual sales of €95 billion, invests some €7.5 billion in R&D and employs around 500,000 highly skilled workers. For more information visit www.eucomed.org and www.reforminghealthcare.eu

More information

Ingmar de Gooijer
Director Communications
E: ingmar.degooijer@eucomed.org
T: +32 (0)2 775 92 24
M: +32 (0)492 97 14 70

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