Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Nov 2018
Review[E-cigarettes: Perceived harmfulness and use for smoking cessation].
The perception that e‑cigarettes are less harmful than traditional tobacco products can influence the consumption of e‑cigarettes. ⋯ Only one-third of the population knows that e‑cigarettes are less harmful to health than conventional cigarettes. The perception of health risks is related to the usage of e‑cigarettes for smoking cessation.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Nov 2018
Review[The decline of cigarette smoking among adolescents and young adults in Germany and the rising relevance of waterpipes, e‑cigarettes and e‑hookahs].
National and international studies indicate that despite the decline in the consumption of traditional tobacco cigarettes, the consumption of other products, such as waterpipes (or hookahs), e‑cigarettes or e‑hookahs (a variant of e‑cigarettes), may be increasing. In addition to the long-term change in smoking behaviour, this article examines how the prevalence of smoking tobacco cigarettes, waterpipes, e‑cigarettes and e‑hookahs in adolescents and young adults in Germany has developed between 2007 and 2016. ⋯ In comparison to tobacco cigarettes, the consumption of waterpipes, e‑cigarettes and e‑hookahs is becoming increasingly important among adolescents and young adults. Thus, these products must also be considered in the planning and design of preventive measures for the prevention of smoking.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · May 2018
Review[Global and national strategies against antibiotic resistance].
Antimicrobial resistance (AMR) is increasingly perceived as a global health problem. To tackle AMR effectively, a multisectoral one health approach is needed. We present some of the initiatives and activities at the national and global level that target the AMR challenge. ⋯ Member states endorsed the action plan during the World Health Assembly 2015 and committed themselves to develop national action plans on AMR. The German Antibiotic Resistance Strategy (DART 2020) is based on the main objectives of the global action plan and was revised and published in 2015. Several examples of the implementation of DART 2020 are outlined here.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Mar 2018
Review[Qualification and classification of medical apps : What should be noted and what is BfArM's contribution?]
Smartphones and tablets with their nearly unlimited number of different applications have become an integral part of everyday life. Thus, mobile devices and applications have also found their way into the healthcare sector. For developers, manufacturers, or users as well, it is often difficult to decide whether a mobile health application is a medical device. ⋯ This article first presents the regulatory framework and subsequently introduces the reader to the Federal Institute for Drugs and Medical Devices' (BfArM) view of the criteria for differentiating between apps as non-medical products and apps as medical apps as well as the classification thereof. Various examples are presented to demonstrate how these criteria are applied practically and options that support developers and manufacturers in their decision making are shown. The article concludes with a reference to current developments and offers a perspective on the new European medical device regulations MDR/IVDR (Medical Device Regulation/In-Vitro Diagnostic Regulation) as well as on future challenges regarding medical apps.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Mar 2018
Review[Software as medical devices/medical apps : Tasks, requirements, and experiences from the point of view of a competent authority].
Software can be classified as a medical device according to the Medical Device Directive 93/42/EEC. The number of software products and medical apps is continuously increasing and so too is the use in health institutions (e. g., in hospitals and doctors' surgeries) for diagnosis and therapy. Different aspects of standalone software and medical apps from the perspective of the authority responsible are presented. ⋯ The future legal framework, the Medical Device Regulation, will strengthen the requirements and engage notified bodies more than today in the conformity assessment of software as a medical device. Manufacturers, health institutions, notified bodies and the authorities responsible are in charge of intensifying their efforts towards software as a medical device. Mutual information, improvement of skills, and inspections will lead to compliance with regulatory requirements.