[Medical devices and patient safety from the clinicians' view].
In daily routine, clinically orientated physicians are confronted with various, often highly sophisticated medical devices. To ensure safe handling and usage, licensees and operators of those devices have to follow regulations and laws given by the German medical device legislation. For the clinician as an active user of the technology, basic knowledge of these regulations is essential. Quality-based health care focuses on the important issue of patient safety. Medical devices have made their way into virtually every sector of patient care. However, despite usage of these devices bearing substantial risk of adverse events, the problem of safe handling of sophisticated technology plays only a minor part in medical academic studies, medical specialist training, and manda nottory continuing education of physicians. The option of further education is needed to ensure patient safety and protect operators of medical devices.
Klinik und Poliklinik für Herzchirurgie, Universitätsklinik Bonn, Sigmund-Freud-Strasse 25, 53105, Bonn, Deutschland. fritz.mellert@uni-bonn.de
F
F
Mellert
D
D
Mallek
D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005858:Germany; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D017751:Safety Management / Q000331:legislation & jurisprudence*