Considerations in designing and testing plasma devices for medical applications

Cold atmospheric plasma has been shown to have great potential for many applications on or in the human body, such as disinfection, wound healing, and cancer treatment. Several medical plasma devices have been developed and have obtained CE certification. However, the route there and into clinical practice is not straightforward. Already during the design stage, many matters need to be taken into account: (1) application and user requirements, (2) medical device regulations, e.g. on electrical safety and electromagnetic compatibility, and (3) production-related issues. Subsequent research should be conducted using a setup that resembles the clinical situation as closely as possible, since seemingly insignificant factors can have a large influence on the plasma and its effects. To ensure that the CE marked device will actually be adopted in clinical practice requires further actions during the research and development process: the demands and concerns of all parties directly and indirectly involved in its use should be identified and at least the crucial parties should be acquainted with plasma medicine and the specific medical device. Some examples will be given from the R&D process of a new flexible volume Dielectric Barrier Discharge (vDBD)