[Delegation of medical activities in acute pain therapy]. / Delegation ärztlicher Tätigkeiten in der Akutschmerztherapie.

Acute pain management is an interprofessional and interdisciplinary task and requires a good and trustful cooperation between stakeholders. Despite provisions in Germany according to which medical treatment can only be rendered by a formally qualified physician ("Arztvorbehalt"), a physician does not have to carry out every medical activity in person. Under certain conditions, some medical activities can be delegated to medical auxiliary personnel but they need to be (1) instructed, (2) supervised and (3) checked by the physician himself; however, medical history, diagnostic assessment and evaluation, indications, therapy planning (e.g. selection, dosage), therapeutic decisions (e. g. modification or termination of therapy) and obtaining informed consent cannot be delegated. With respect to drug therapy, monitoring of the therapy remains the personal responsibility of the physician, while the actual application of medication can be delegated. From a legal perspective, the current practice needs to be stressed about what is within the mandatory requirements and what is not when medical activities are delegated to non-medical staff. The use of standards of care improves treatment quality but like any medical treatment it must be based on the physician's individual assessment and indications for each patient and requires personal contact between physician and patient. Delegation on the ward and in acute pain therapy requires the authorization of the delegator to give instructions in the respective setting. The transfer of non-delegable duties to non-medical personnel is regarded as medical malpractice.

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

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.