Monitoring Blood Supply in Germany: A Regulatory Perspective

Abstract

<b><i>Background and Objectives:</i></b> 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. <b><i>Materials and Methods:</i></b> Selected data on blood collection and supply from 2009 to 2021 derived from the §21 German Transfusion Act database were examined. In addition, a pilot study over a period of 12 months was conducted on a voluntary basis. The number of red blood cell (RBC) concentrates was documented and stock availability was calculated weekly. <b><i>Results:</i></b> From 2009 to 2021, the annual number of RBC concentrates decreased from 4.68 to 3.43 million, the per capita distribution decreased from 58 to 41 RBC concentrates per 1,000 inhabitants. These figures did not change significantly during the COVID-19 pandemic. The data of the 1-year pilot project represented 77% of the released RBC concentrates in Germany. Percentage share of O RhD positive RBC concentrates fluctuated between 35% and 22% and for O RhD negative concentrates between 17% and 5%. The availability of O RhD positive RBC concentrate stocks varied between 2.1 and 7.6 days. <b><i>Conclusion:</i></b> The data presented shows a decrease in annual RBC concentrate sales over an 11-year period and no further change over the past 2 years. A weekly monitoring of blood components detects acute problems in RBC provision and supply. Close monitoring seems helpful but should be combined with a nationwide supply strategy.

How to Ensure Blood Supply and Blood Safety in the Future

“…All manuscripts published within the focus topic “Blood Supply and Blood Safety” in this issue of Transfusion Medicine and Hemotherapy deals with partial aspects of the abovementioned WHO activities in one way or another. Fiedler et al [ 3 ] reported from a regulatory perspective about the necessity of a nation-wide monitoring not only of blood donations but also of blood consumptions and at best blood inventories at blood establishments and hospitals in order to anticipate blood shortages (e.g., due to crisis such as COVID-19 pandemic) and to initiate measures to manage those blood shortages reasonably and timely (e.g., regional compensation by exchange, postpone elective surgery). Samukange et al [ 4 ] summarize the activities of BloodTrain funded by the German Ministry of Health.…”

“…Blood Supply and Blood Safety" in this issue of Transfusion Medicine and Hemotherapy deals with partial aspects of the abovementioned WHO activities in one way or another. Fiedler et al[3] reported from a regulatory perspective about the necessity of a nation-wide monitoring…”

Patient Blood Management: We Still Have Work to Do

“…However, the amount of currently stored blood products is not available in real time. Fiedler et al [ 2 ] examined the number of whole blood donations from 2009 to 2021 and explored the feasibility of a weekly reporting system. The authors observed that the number of whole blood donations decreased from 4.86 million in 2009 to 3.67 million in 2020 and 3.7 million in 2021.…”

“…Using a weekly monitoring approach, Fiedler et al [ 2 ] assessed the number of RBC unit stocks and analyzed the supply sufficiency, which was defined as a reserve of RBC units for three or more days. The authors showed that relative to the total number of RBC units, the share of blood type O and RhD positive RBC units fluctuated between 35% and 22% and for O and RhD negative RBC units between 17% and 5%.…”

“…In addition, wastage of blood components is an important issue at blood banks and hospitals. Fiedler et al [ 2 ] investigated the number of expired RBC units, and showed that 2.7% of the RBC units, which corresponds to approximately 111,000 units, expire annually at blood banks in Germany. In 2019, the expiration rate was 3.6% per 100 RBC units at blood banks and about 4.2% per 100 RBC units at healthcare establishments.…”