6th Workshop "Metrological Applications of Ultrasound" organised by the DEGA e.V. Ultrasound Committee.
We participated with the following contribution:
Risk assessment according to standardised criteria of freely available ultrasound devices for diagnostic and cosmetic home use
A. Schlesinger, M. Schultz, G. Dietrich, R. Klaua, K. V. Jenderka
Ultrasound devices for home use (e.g. devices for prenatal examinations, simple therapy devices, cosmetic devices) can be freely purchased via international trading platforms. Although the national legislator has formulated regulatory requirements for the market entry of such products in the Product Safety Act and the Medical Devices Act, it is suspected that many manufacturers of the product groups do not fulfil these requirements and that there is a risk to the public due to the nature of the products and possible improper use.
To this end, the Federal Office for Radiation Protection initiated a research project to assess the hazard potential for these freely available sources.
After extensive research, measurement and evaluation methods were developed to assess the ultrasonic field parameters and the surface temperature of the devices and implemented in suitable measurement setups. Sixteen representative ultrasonic devices were selected from the market (online shops) and analysed over a period of two years. During this process, considerable individual metrological challenges arose for which specific solutions had to be developed.
The results of our investigation indicate an extraordinarily high risk potential for many of the analysed devices, especially when used freely by laypersons, whereby both thermal and mechanical hazards from the ultrasound itself, but also thermal hazards from overheating of the application parts were identified. These risks can lead to considerable damage to health, even if the devices are used as intended.
It was also found that the current state of standards does not adequately reflect the time-integrated ultrasonic energy quantities. This points to a potential gap in the current standardisation landscape, making it difficult to assess the devices accurately and comprehensively.
