New Guideline on Haemotherapy

Recommendation

5/6 November 2024

Blood, Plasma and Stem Cells - Audits and Inspections - Live Online Training
From regulatory background to preparation and final performance

The "Guideline on the collection of blood and blood components and on the use of blood products" was revised by the German Medical Association (Bundesärztekammer - BÄK) in cooperation with the Paul-Ehrlich-Institut (PEI - the German Federal Institute for Vaccines and Biomedicines). In addition to several adjustments, a short-term update had to be made according to the new UPD Reform Act (Stiftung Unabhängige Patientenberatung Deutschland).

The biggest - also politically relevant - adjustment here was the change to the regulations on the assessment of individual sexual behaviour, which have been in force since May. The sexual orientation, gender identity of the person willing to donate and sexual partners are no longer relevant. Donations are to be rejected in future if the sexual behaviour of the donor has been risky within the last four months. This includes the following points:

• Sexual intercourse with more than two persons in total 
• Sexual intercourse with a new person if anal intercourse was practised in the process 
• Sex work and its use 
• Sexual intercourse with a person infected with hepatitis B, hepatitis C or HIV or who lives in an endemic area/high prevalence country for these viruses or has entered from there.

Furthermore, further adjustments were also made and supplemented in the new Haemotherapy Guideline:

• Production of hyperimmune plasma on the basis of § 12a TFG (Transfusionsgesetz - German Transfusion Act) according to new scientific and technical standards and thus the determination for donor immunisation taking into account § 8 TFG. 
• Use of telemedical procedures 
• Amendment to the maximum age limit for those willing to donate

The new guideline helps to ensure that patients receive targeted, effective and safe blood products and that blood donors are not harmed by their donation. Please also read the complete amendment 2023 with further changes or the complete guideline on the collection of blood and blood components and the use of blood products (guideline haemotherapy).