The Minister of health, Jens Spahn (CDU), has presented a bill for an implant Register. This will bring for patients, more safety, if you are in need of knee prostheses, heart pacemakers and other implants. “Thus we, who when built who know something,” said Spahn of the “Rheinische Post”.
In comparison to drugs, the hurdles for the approval of medical products are extremely low – even when it comes to critical products such as pacemakers or hip replacements. After the scandal around faulty breast implants, the System was revised in the year 2017, while Europe-wide.
However, experts criticize several issues: unlike medicines, so-called Notified Bodies to decide on the admission. These are, however, financially from the contracts of the company. Manufacturers may also choose a Europe-wide body. Elaborate studies show that the medical devices do more good than harm, you do not need to show the manufacturer so far.
Data so far remain in secret
Yet it is for Doctors and patients is hardly possible to compare different medical products and select the best. This is partly due to the fact that the data on the basis of which a product has been approved, often remain secret. On the other, a directory in which all the available medicine, are listed on the products is missing. What you should know patients, read here.
The last point to change Spahn now. With the Register it is possible to inform all affected patients, if problems with a product occur. The responsible health-care facilities, patients, and the manufacturer would be obliged to join the Register, – stated in the draft law.
The law should take effect at the beginning of the year 2020. The structure of the register will take, according to the Minister of health, however three to five years. “Even if a product is in order, we gain insights about its durability and quality,” said Spahn.
Also in the coalition agreement agreed to the introduction of the electronic patient record by 2021 wants to accelerate Spahn, he threatens to health insurance penalties. “We will not provide financial penalties for the funds to meet it,” he said. You would be reduced to 2.5 percent for administrative expenses.