Implants, or prostheses can cause media searches, according to the increasingly serious problems and even deaths. Reason for this is that many of these medicine tested products in Europe is insufficient on the market. The Federal Ministry of health, discussed now, such as the Monitoring of medicine products can be improved.
The project under the title "The Implant Files”, in which more than 250 journalists from 36 countries were involved, revealed on Monday that defective medical products could be for numerous injuries and deaths. In Germany, researched the NDR, WDR and Süddeutsche Zeitung.
The Federal Ministry of health (BMG) take this research, according to a press release of the North German radio very seriously. "Every single described there the case is tragic and one to viel", a spokesman for BMG, said at a press conference. It will now be discussed, whether the competencies of the Federal Institute for drugs and medical devices (BfArM) can be expanded in the Monitoring of medical devices and implants. So far, the BfArM can’t call back the products, but the competent länder authorities, such a recall is only recommend. These can then decide themselves whether to pull the product from the market. Since 2010 in Germany there were only six statutorily mandated recalls for medical devices.
Another Problem, according to the research composite that medical products do not need to be controlled in Europe from government Agencies and certified, as is the case of medicinal products the case. The review is available only through private institutions, which are in the order of the manufacturer.
In addition to the measures at the Federal level, according to the spokesman of the BMG within the European Union efforts in the fight against harmful medical products. A corresponding regulation was adopted to reach not later than the year 2020. This will be referred to the NDR and, in many points, by experts as inadequate, since the basic System with a private verifiers. Sole and exclusive remedy for a state license, such as in the case of medicinal products could create.
NK
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