A world-wide research network has seen the authorisation, control and fault management of medical devices, particularly implants. The result of hit on Monday, high waves, even in politics. The most important questions and answers on the topic:
Who has researched?
the “Implant Files” were involved in 60 media, including in Germany, NDR, WDR and “Süddeutsche Zeitung”. They have researched according to their own figures of one and a half years, in 36 countries, and requests filed, thousands of files are spotted, and with hundreds of patients and experts spoke.
What has the network found out?
The core allegation: In contrast to medicinal products, which are tested prior to admission carefully, would not medicine controlled products by the government and issues are not systematically recorded. The System was “manipulated, flawed and responsible for untold Dead”.
how To fix it?
In the broadest sense to medical products –that is, everything which the Sick are treated without drugs, from the wheelchair to the pavement. In a narrower sense, it comes to implants –that is, products that are permanently inserted into the body, such as cardiac catheterization, knee joints, or insulin pumps. The medical products are divided into four risk groups,low risk (Thermometer) up to very high risk (breast implant).
How the procedure runs?
A medical product according to the Federal Institute for drugs and medical devices (BfArM) no official authorisation procedures. The manufacturer only has to prove “that its product is safe and the technical and medical services are also fulfilled by him”. Part of the evaluation process was “always a clinical evaluation, in certain cases, a clinical examination”.
Who checks?
The BfArM is called “notified Bodies” –according to the research network, there are approximately 50 private providers such as TÜV or Dekra. The given, the “CE”mark was “use a seal of quality for the Patient, but rather a Marketing label”, is quoted as a health scientist. Many of the applications will be examined in the research, also only on paper.
