Berlin - Knee prostheses, pacemakers and other implants will have to be registered centrally in this country in the future. In order to increase the quality of the products and thus the safety of the patients, the Bundestag decided tonight mandatory state database, which is expected to be used from 2021. The reason for this are cases such as the scandal surrounding inferior breast implants, in which an unapproved silicone gel had been used for years.
Federal Health Minister Jens Spahn (CDU) spoke of an important step towards more safety. "Patients should be able to be sure that implants meet the highest quality standards and that they are informed quickly in the event of problems with implants." But for the opposition the project does not go far enough. “In its current form, the register falls far short of our expectations and the requirements from practice,” complained about Kordula Schulz-Asche from the Greens.
In addition to the implant register, this also includes regulation through the new one Treatment methods can be paid for by the health insurance company faster than before. The Federal Joint Committee () responsible for the decision must in future complete its assessment after two years instead of three years.
Praise came from the German Medical Technology Association (). "We support the mandatory introduction of the register and we are committed to rapid practical implementation and appropriate involvement of the medical device industry," said BVMed managing director Marc-Pierre Möll.
The manufacturers represented in BVMed had Many years of experience with the successfully established endoprosthesis register () and the aortic valve register (). “The endoprosthesis register has shown how successful the cooperation between doctors, health insurance companies and manufacturers can be. This contributes to improving patient care and safety, ”says BVMed.
The anti-corruption organization also gave its approval. However, she also warned that the approval practice for implants must be stricter and more transparent. The protection of patient data is also not adequately regulated; the centralization of data goes too far.