The Paul-Ehrlich-Institut supports African authorities in the establishment of regulatory structures for the availability, quality, and safety of blood and blood products. The Paul-Ehrlich-Institut's BloodTrain Next Generation project team organised its first on-site workshop in Rwanda on the topic of evaluating the technical documentation of in vitro diagnostic medical devices (IVDs) that test blood. IVDs are test products that can be used to examine samples from the human body – be it saliva, urine or blood – for certain pathogens or factors. As IVDs are of great importance for safety in the blood supply, experts from the Paul-Ehrlich-Institut have been supporting African partner countries since 2019 in building up competencies and effectively regulating IVDs.
BloodTrain Next Generation workshop in Rwanda
Source: Paul-Ehrlich-Institut
National medicines authorities from 14 African countries took part in the three-day workshop in Rwanda. The focus of the workshop was on practical exercises in which the participants checked manufacturers' technical documentation for compliance with safety and performance requirements. The participants also engaged in dialogues with representatives from other nations on challenges and solutions in the field of blood and blood product safety. The training built on the virtual IVD introductory seminar conducted in 2021 as part of the BloodTrain project.
"In contrast to the members of the European network, which has grown over a period of many years, African regulators have had only limited opportunities to intensively exchange information with other African nations on specific questions and challenges in the field of in vitro diagnostics," stated Dr Jens Reinhardt, head of the BloodTrain Next Generation project at the Paul-Ehrlich-Institut. Therefore, networking – "learning from each other" and the exchange of best practices – was the focus of the workshop.
Various IVDs are used in the processing of blood or blood components, e.g. to determine blood type or to detect pathogens that can be transmitted by blood transfusions. Blood transfusions pose a high risk to both individual and public health. This is why most IVDs used for blood testing are assigned to class "D", the highest risk class. As a result of this assignment, IVDs used for the examination of blood are subject to the strictest regulatory controls to ensure the reliability of the test results, which is of great importance for both individuals and the general public.
Strict requirements apply to the highest risk class. For example, the tests must have a high sensitivity, which means they must reliably give a positive result for samples with pathogens (sensitivity) and reliably show a negative result for samples without pathogens (specificity). The authorisation and monitoring of IVDs used in blood testing is the responsibility of national medicines authorities to ensure that patients have access to safe blood or blood products. Since the principles that apply to the regulation of blood-testing IVDs are the same as those that apply to all medical devices, the participants of the BloodTrain Next Generation Workshop in Rwanda can apply their knowledge to all IVDs.
BloodTrain Next Generation is the continuation of the Paul-Ehrlich-Institut's BloodTrain project, which ran from 2016 to 2022. The project is part of the Global Health Protection Programme (GHPP), a programme of the German Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) to improve global health.
Updated: 04.10.2024
