Paul-Ehrlich-Institut

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Infographic – Responsibility for Blood and Blood Products

Text Version

Responsibility for Blood and Blood Products

The Paul-Ehrlich-Institut is the German higher federal authority responsible for the safety, quality, and efficacy of blood and blood products. These products include blood components obtained from human blood for transfusion, blood components obtained from human plasma, and analogues produced using biotechnology.

The aim is to identify the risks of blood-borne infectious agents at an early stage and to take appropriate risk-minimising measures.

How the Paul-Ehrlich-Institut Contributes to the Safety of Blood Products

  • The Institute monitors the collection, production, and use of blood components.
  • Its monitoring activities include the use of modern screening methods, risk assessments, and the introduction of appropriate measures to minimise risk.
  • The Institute also checks and assesses the authorisation of medicinal products produced from plasma (e.g. coagulation factors, fibrin glue).

Reporting Creates Transparency

Haemovigilance Report

The Paul-Ehrlich-Institut receives and evaluates reports on

  • serious adverse transfusion reactions in recipients,
  • serious adverse reactions in donors,
  • and serious adverse events in the transfusion chain.

Transfusion Report

The Paul-Ehrlich-Institut publishes data from blood and stem cell donation facilities as well as healthcare facilities on the

  • collection,
  • manufacturing,
  • administration,
  • import and export, and
  • expiration

of blood, blood products, and stem cell preparations.

Blood Donation Barometer Shows National Supply Levels

Since 2021, the Paul-Ehrlich-Institut has worked with cooperating blood donation institutions to keep records on the supply of erythrocyte concentrates throughout Germany and publish the information weekly on its website.

www.pei.de/blooddonationbarometer

The barometer allows for the detection of imminent, blood groupspecific supply shortages in good time and the initiation of any necessary corrective measures by the blood donation services.