Cold atmospheric pressure plasma for treatment of chronic wounds: drug or medical device?

摘要

Objective:\udThe use of cold atmospheric pressure plasma (CAPP) as a new therapeutic option to aid the healing of chronic wounds appears promising. Currently, uncertainty exists regarding their classification as medical device or medical drug. Because the classification of CAPP has medical, legal, and economic consequences as well as implications for the level of preclinical and clinical testing, the correct classification is not an academic exercise, but an ethical need.\ud\udMethod:\udA multidisciplinary team of physicians, surgeons, pharmacists, physicists and lawyers has analysed the physical and technical characteristics as well as legal conditions of the biological action of CAPP.\ud\udResults:\udIt was concluded that the mode of action of the locally generated CAPP, with its main active components being different radicals, is pharmacological and not physical in nature.\ud\udConclusion:\udDepending on the intended use, CAPP should be classified as a drug, which is generated by use of a medical device directly at the point of therapeutic application.