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First annual haemovigilance activity report released after universal implementation of INTERCEPT™ in France

31/01/2020

Successful Implementation of INTERCEPT™ Blood System at EFS

Pathogen inactivation of platelet concentrates (PC) with the INTERCEPT Blood System has been universally implemented in metropolitan France from November 2017 onwards. Previously INTERCEPT had been deployed since 2006 in Alsace and in the French overseas departments.

In follow-up of this implementation “L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)” in cooperation with “l’Établissement Français du Sang (EFS)” and “Le Centre de transfusion sanguine des armées (CTSA)” has set up surveillance of both the adverse reactions and consumption of PCs.

In December 2019 the ANSM published its annual haemovigilance activity report and concluded that the transfusion monitoring data in 2018 after transfusing ~320.000 PCs are fully in line with expectations, especially with regard to the reduction of transfusion transmitted infectious diseases.

Highlights of the 2018 haemovigilance activity report on transfusion of PC are:

  • No bacterial infection transmitted by transfusion (15 transmissions occurred in previous 5 years).
  • No transmission of arbovirus, HTLV or parasites by transfusion.
  • Fewer allergic reactions observed, however, difference is not statistically significant.
  • Fewer refractory incidences observed, however, difference is not statistically significant.  

This surveillance will continue in 2019 in order to validate the trends observed in 2018.

Interested to know more?

Consult key data ANSM haemovigilance   activity Report 2018 (English) 

Consult full data ANSM haemovigilance   activity Report 2018 (French)   see page 130 - 134