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Pathogen inactivation of blood components during outbreaks of infectious diseases in the European Union

27/02/2020

ECDC2

The European Centre for Disease Prevention and Control (ECDC), in co-operation with the Italian National Blood Centre, organized an expert consultation meeting (April 2019) to discuss the potential role of pathogen inactivation technologies (PI) as a blood safety intervention during outbreaks of infectious diseases for which (in most cases) laboratory screening of blood donations is not available. 

The meeting brought together 26 experts and representatives of national competent authorities for blood.

Summary of expert opinions
1

  • Despite the relatively rare occurrence of Transfusion Transmitted Infections (TTIs), the microbial safety of transfusion continues to arouse substantial medical, public and political interest.
  • As of April 2019, sixteen (52%) EU/EEA member states and Switzerland are regularly using PI in the routine preparation of PLTs and/or plasma. PI is slowly but steadily being incorporated into standard transfusion practices.
  • The changing epidemiology of existing infections and the increasing frequency of emerging and re-emerging infectious diseases outbreaks (EID) may continue to challenge the safety of the blood supply. A continuing strategy of additional screening and donor deferral for microbial safety is unlikely to be sustainable in the future. A complete interruption of all donations, especially in big cities or remote islands, could jeopardize the supply of PLTs due to their short storage time.
  • PI technologies have been applied during several outbreaks of arthropod-borne viruses, and are now recognized as a major advance and strategy to minimize the risk of TTIs in future EID epidemics. Apheresis plasma and PLT collections continued in the affected areas provided that these were treated with PI.
  • Experience in using PI during infectious disease outbreaks has shown that, if PI is already in use, the time to switch on or scale up the use of this technology in an affected area is shorter than it would be if it is not in use, allowing time to produce sufficient PI-treated blood components to cover the local demand. Data presented at the meeting showed that the time required for planning, implementing changes and receiving approval of the PI process may take over 6 months. This does not take into account the time for scientific evaluation and validation of PI on a local level. However, once PI is in place, only a short lead time is required to scale up production to cover the need for PI blood components.
  • Thus, a country at risk of infectious disease outbreaks that threaten the safety of the blood supply may consider implementing PI (at least partially in strategically selected blood centers) also to improve national capacity and capability to respond to infectious disease outbreaks for which a screening test is not available or practical.
  • The operational decision to implement PI should, regardless of the benefits and limitations, consider above all the improvement in blood safety achieved by PI during a potential outbreak or epidemic.

Want to know more on the potential use of PI as a part of preparedness and response to threats posed to blood safety by outbreaks of emerging and re-emerging infectious diseases outbreaks (EID)?

  • Access the articles representing the expert opinion from the ECDC consultation meeting. 

ECDC Consultation meeting

  • How the Centro de Transfusión de la Comunidad de Madrid prepared themselves for EID.

Download presentation

Reference:
1Pathogen reduction of blood components during outbreaks of infectious diseases in the European Union: an expert from the ECDC consultation meeting; D. Domanovic et all.; Blood Transfus. 2019 Nov; 17(6): 433 - 448.