The Bundestag has decided that the knee prostheses, heart pacemakers and other implants need to be registered in Germany in the future, Central. The mandatory national database will help to increase the quality of the products and ensure the safety of the patients. The Register is expected to be in 2021 to be used.
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 drugs, no Central authorities, but the so-called Notified Bodies concerning the authorisation to decide. These are, however, financially from the contracts of the companies. 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.
“Important step for greater security”
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.
The decision of the Bundestag is an important step for more security, said Minister of health, Jens Spahn (CDU). “Patients should be able to be sure that implants are of the highest quality and you will be informed in case of problems with the implants quickly.”
The Opposition to the project but does not go far enough. “In its current Form, the Register remains far behind our expectations and the requirements of the practice,” said Kordula Schulz-ashes of the Green.
In addition to the implants-Register, the law also includes a regulation, by the new methods of treatment more quickly than previously from the health insurance Fund can be paid. For the decision with the competent Federal Joint Committee of insurers, Doctors and hospitals must complete its evaluation after three years in the future, after only two years.