Monitoring Blood Supply in Germany: A Regulatory Perspective.

Background And Objectives: A sufficient supply of safe, high-quality blood components for transfusion is essential to the healthcare system in Germany. The requirements for the current reporting system are laid down in the German Transfusion Act. The present work elaborates on the advantages and limitations of the current reporting system and investigates the feasibility of a pilot project that collects specific data on blood supply based on weekly reports.

Follow-Up of Plasma Donors after Quarantine Storage: Results of a 5-Year Survey in Germany.

Background And Objectives: In 1993, a quarantine storage of 6 months was introduced for plasma for transfusion and was reduced to 4 months in 2003, owing to the improvements of screening assays used in German blood establishments. The presented survey analyses the value of quarantine storage under the current screening conditions.

Materials And Methods: From 2015 to 2019, we collected data on the total amount of released quarantine plasma as well as on the number of quarantine plasma not released due to a reactive screening test of a follow-up donation.

Population-Based Analysis of the Impact of Demographics on the Current and Future Blood Supply in the Saarland.

Background: The federal state of Saarland (SL) is experiencing the fastest demographic change in the western part of Germany. In this study, we analyzed retrospective data on the current and future supply of red blood cell concentrates (RBC) in this region and compared it to the current and future RBC demand in SL hospitals.

Methods: The projection of the SL blood supply in 2030 was modeled based on SL demographics for age distribution and donation frequency of donors, and the RBC transfusion data for in-house patients.

West Nile and Usutu Virus Infections and Challenges to Blood Safety in the European Union.

West Nile virus (WNV) and Usutu virus (USUV) circulate in several European Union (EU) countries. The risk of transfusion-transmitted West Nile virus (TT-WNV) has been recognized, and preventive blood safety measures have been implemented. We summarized the applied interventions in the EU countries and assessed the safety of the blood supply by compiling data on WNV positivity among blood donors and on reported TT-WNV cases.

Impact of hepatitis E virus testing on the safety of blood components in Germany - results of a simulation study.

Hepatitis E virus (HEV) infections may be acquired through transfusion of blood components. As transfusion-transmitted infections mostly affect vulnerable individuals, measures to ensure the supply of safe blood components are under discussion. On the basis of the epidemiological situation in Germany, different testing strategy scenarios were investigated through simulation studies.

[Report on notifications pursuant to §21 German Transfusion Act for 2010 and 2011].

This report covers the blood supply situation in Germany over the past 12 years and provides detailed data on the years 2010 and 2011. Nearly 7.6 million donations, thereof 4.

Transfusion-Transmitted Bacterial Infections - Haemovigilance Data of German Blood Establishments (1997-2010).

SUMMARY: METHODS: In order to evaluate the benefit of risk minimisation measures, reporting rates of transfusion-transmitted bacterial infections (TTBI) were calculated on the basis of annual reports and distributed blood components. Following the implementation of risk minimisation measures in 2003 and 2008, a comparison of pre- and post-implementation periods was performed. RESULTS: During a period of 14 years, 90 cases of TTBI were confirmed, 34 were caused by red blood cell (RBC) concentrates, 5 by fresh frozen plasma, and 51 by platelet concentrates (PCs).

Benefit of transfusion-related acute lung injury risk-minimization measures--German haemovigilance data (2006-2010).

Objective: Based on the frequency of immune-mediated and non-immune-mediated transfusion-related acute lung injury (TRALI), the effect of risk-minimization measures was evaluated during a period of 5 years (2006-2010). Risk-minimization measures were implemented in 2008/2009, consisting of exclusion of female donors with a history of pregnancy or exclusion of female donors with human leucocyte antigen (HLA)/human neutrophil alloantigen (HNA) antibodies.

Methods: TRALI was confirmed according to the criteria of the International Haemovigilance Network.

Report on Notifications Pursuant to §21 German Transfusion Act for 2008 and 2009.

SUMMARY: This report contains the data collected in 2008 and 2009, pursuant to Section 21 German Transfusion Act as well as an overview of the supply situation during the last 10 years. In 2009, blood donation services reported a total of 7.5 million donations - the largest amount since 2000.

[Report on notifications pursuant to Section 21 of the German Transfusion Act for the years 2008 and 2009].

This report contains the data collected in 2008 and 2009, pursuant to Section 21 of the German Transfusion Act (Transfusionsgesetz), as well as an overview of the supply situation during the last 10 years. In 2009, blood donation services reported a total of 7.5 million donations--the largest amount since 2000.

Report on Notifications Pursuant to section sign21 German Transfusion Act for 2007.

The present report contains the data collected in 2007, pursuant to Section 21 German Transfusion Act, and an analysis of the supply situation over the past 8 years. As in previous years, all blood donation centres located in Germany transmitted data on the collection, manufacture, import and export of blood components for transfusion. According to these data, a total of 6.

[Evaluation of measures aimed to reduce serious adverse transfusion reactions (hemovigilance data from 1997 to 2008)].

On the basis of reports of serious transfusion reactions, measures aimed to improve the safety standard of the manufacturing process of blood components were evaluated from 1997-2008. Measures of the Paul-Ehrlich-Institut (PEI) as well as recommendations of the Advisory Committee "Blood" were considered. Reporting frequencies before and after the implementation of measures were compared.

Management of blood supplies during an influenza pandemic.

Background: Blood supplies are delicate resources, particularly vulnerable to incidents affecting the health of donors. The critical impact of a pandemic on the availability of red blood cells (RBCs) has been demonstrated in previous research; however, a detailed estimate of the expected deficit is missing. This has become a priority issue in the face of the current influenza pandemic.

[Report on notifications pursuant to Section 21 German Transfusion Act for 2007].

The present report contains the data collected in 2007, pursuant to Section 21 Transfusionsgesetz (German Transfusion Act), and an analysis of the supply situation over the past eight years. The recording of the data by online reporting is in the meantime well established and generally accepted. As in previous years, all blood donation centers located in Germany transmitted data on the collection, manufacture, import and export of blood components for transfusion, so that meaningful data are available.

[Report on notifications pursuant to Section 21 German Transfusion Act for 2005 and 2006].

In 2007, for the first time since the introduction of reporting pursuant to Section 21 of the German Transfusion Act, a timely report including data collected concerning the previous year can be published. In this report on the years 2005 and 2006, a trend analysis over the 7 years since 2000 can be presented. Thereby the favourable result is confirmed that, thanks to sustained reliable reporting on collection, manufacture, import and export of blood and blood products, interesting and meaningful data on the amount of available medicinal products are provided.