[Medical devices. Regulatory framework and contribution of the German Federal Institute for Drugs and Medical Devices (BfArM) to the safe application]. / Medizinprodukte. Regulatorischer Rahmen und Beitrag des BfArM zur sicheren Anwendung.

Medical devices are of great importance for the prevention, diagnosis and treatment of many diseases. With their broad range and interdisciplinarity, they represent both a very dynamic field of innovation and a significant sector of the economy. The European and thus the German Medical Devices Act aim in this context to make new medical devices for patients and users rapidly available while ensuring safety and performance at the same time. The main responsibility for this lies with the manufacturer. In addition, others are involved in a complex collaboration in the conformity assessment and also later in the marketing phase for the early identification, assessment and minimization of potential risks. This paper presents the legal framework for medical devices and the related roles and responsibilities of various stakeholders, especially the two federal agencies the German Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI). From the perspective of the BfArM the procedure and criteria for risk assessment of incident reports are explained and the experiences and wishes from regulatory practice are described. The active engagement of the BfArM to contribute knowledge from the incident report assessment within the relevant standards organisations and the medical profession is described using examples of medical devices from the field of out-of-hospital ventilation. The paper concludes with a look at future challenges, e.g. in combination products, IT networks and automatization, as well as on current developments to improve risk identification and assessment in a European context.

[Importance of the Therapeutic Products Act for the ENT practitioner]. / Was sollte der HNO-Arzt über das aktuelle Medizinprodukterecht wissen?

The Therapeutic Products Act controls therapeutic products and their fields of application, and classifies them legally. The present regulations on therapeutic products are based on a fundamental concept comprising basic demands, harmonized standards, agreement of the product attributes with the basic demands, and assessment of conformity. Therapeutic products (among which in vitro diagnostics are counted) must comply with definite regulations and are separated from medicines by their mode of action. In addition, therapeutic products must be subject to critical testing. The establishment, management, and use of therapeutic products are, with few exceptions, governed by the Regulations for the Use of Therapeutic Products. To avoid possible risks involved in the application of therapeutic products, a well-functioning system of registration is required, controlled by the Regulations on Therapeutic Products Safety.

[Three-dimensional visualization of stationary flow behind artificial heart valves]. / Dreidimensionale Sichtbarmachung stationärer Strömungen hinter künstlichen Herzklappen.

The visualization and quantitative analysis of flow offers a possibility for the hydrodynamic characterization of artificial heart valves. Different types of valves can be compared if velocity profile and the turbulent shear stress caused by the prosthesis are known. The tracer technique was selected, since it permits visualization also of turbulent flow through the valve. With the aid of a simple optical device the three-dimensional flow pattern behind the valve is determinable. The main features of the method are: The regions of interest can easily be identified. Velocity profiles can be determined and shear stress and turbulence intensities estimated. The experimental setup is simple, calibration is not necessary, and it can be used for turbulent flows. The method can be used only with transparent fluids and vessels; measurements in blood are not possible. Because of the large number of measuring points required the method is very time-consuming. The use of an automatic picture analyzing system would make it possible to increase the number of pictures processed, and thus increase resolution. The velocity profile of a three-finger-valve, the TAD 29, was established at a distance of 20 mm from the ring, and compared with known profiles from the literature. The valve has an opening angle of 70 degrees. All typical regions for the flow of an artificial heart valve, such as jet, stagnation gone, backflow and turbulence were demonstrated.