A Kramer1, B R Conway2, K Meissner3, F Scholz4, B H Rauch5, A Moroder6, A Ehlers6, A J Meixner7, C-D Heidecke8, L I Partecke8, M Kietzmann9, O Assadian10. 1. Consultant Clinical Microbiology and Infection Control, Institute of Hygiene and Environmental Medicine, University Medicine Greifswald, Germany. 2. Department of Pharmacy, School of Applied Sciences, University of Huddersfield, United Kingdom; Institute of Skin Integrity and Infection Prevention, School for Human and Health Sciences, University of Huddersfield. 3. Anesthetist, Intensive Care Specialist, Department of Anesthesiology and Intensive Medicine, University Medicine, Greifswald, Germany. 4. Biochemist, Institute of Biochemistry, University of Greifswald, Germany. 5. Medical Pharmacology and Toxicology, Department of Pharmacology, Center of Drug Absorption and Transport, University Medicine Greifswald, Germany. 6. Lawyer, Ehlers, Ehlers & Partner Healthcare Law Firm Munich, Germany. 7. Physicist, Institute of Physical and Theoretical Chemistry Tübingen, Germany. 8. General Surgeon, Department of Surgery, University Medicine Greifswald, Germany. 9. Veterinary Medicine, Pharmacologist, Department of Pharmacology, Toxicology and Pharmacy, University of Veterinary Medicine Hannover, Foundation, Hannover, Germany. 10. Consultant Clinical Microbiology and Infection Control, Consultant Infectious Diseases and Tropical Medicine, Institute for Hospital Epidemiology and Infection Control, Medical University of Vienna, Vienna, Austria.
Abstract
OBJECTIVE: The 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. METHOD: A 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. RESULTS: It 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. CONCLUSION: Depending 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.
OBJECTIVE: The 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. METHOD: A 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. RESULTS: It 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. CONCLUSION: Depending 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.
Authors: Pavol Zubor; Yun Wang; Alena Liskova; Marek Samec; Lenka Koklesova; Zuzana Dankova; Anne Dørum; Karol Kajo; Dana Dvorska; Vincent Lucansky; Bibiana Malicherova; Ivana Kasubova; Jan Bujnak; Milos Mlyncek; Carlos Alberto Dussan; Peter Kubatka; Dietrich Büsselberg; Olga Golubnitschaja Journal: Int J Mol Sci Date: 2020-10-27 Impact factor: 5.923