medical devices to save lives. They include mundane things like a Support stocking, but also pacemakers, hip replacements or tubing, in support of broken vessels. Some of them remain for years in the body. The products are cleanly made, as well as on function and safety have been assessed, it should be a matter of course. But it is not. Instead, they are controlled in Germany, Europe and the world are defective, as also the research project ‘ Implant Files of various international media highlights.
Painful scarring, infections due to hip replacement and decomposing implants are just a few of the serious consequences. In more than 14,000 cases, medical devices have caused in Germany alone in the past year complications, such as, among other things, the journalists from NDR, WDR and Süddeutsche Zeitung have found out. But how could it come to this?
Last triggered in 2015, the scandal surrounding breast implants made of cheap industrial silicone by the French company Poly Implant Prothèse (PIP), excitement and worry. This is also why the policy-makers of the European Parliament and of the Council on medical devices, after years of negotiations, in may 2017 new regulations. You will see an additional control procedures that you define, such as the clinical evaluation of a product, and that product identification numbers to be introduced. In may 2024, the regulations will come into force. But even with the Implant-Files: Already now there are doubts as to how effective the improvements are. What needs to change?
Overview: medical products must not be used as toys and treated, We do not know what is used There is a lack of publicly-funded studies, More Tests with women are needed
not New is necessarily better medical products may not> toys
enough: Rejects the registration, the companies are free to go to another. Since it is hardly surprising that according to research of the Implant-Files-and-team “in the past eight years in Germany 10.254 medical products re-certified, but only 84 applications” were rejected.
What are medical products? What are medical devices?
“medical products are products with a medical purpose, is intended by the manufacturer for the application in humans,” the Definition of the Federal Institute for drugs and medical products. “Unlike pharmaceuticals, the pharmacologically, immunologically-act logically or metabolically, you will achieve the principal intended action of medical devices on the primary on for example physical way“. According to products: implants, products for injection, Infusion, Transfusion and dialysis, pacemakers, and dental products to medicine.
medical products products containing a substance or preparations of substances, or with such a coated are considered in a separate use as a medicament or a constituent of a medicinal product, and in addition to the functions of the product have an effect on the human body can unfold. The statutory Definition of a medical device is included on the national level in paragraph 3 of the law on medical products (MPG), corresponding regulations. European directives RL 90/385/EEC (active implants), RL 93/42/EEC (medical devices) and Directive 98/79/EC (In vitro diagnostic medical devices).
