Health Minister Jens Spahn (CDU) has submitted a bill for an implant registry. This is intended to provide more safety for patients when they need knee replacements, pacemakers and other implants. "So we know who has who built something when," said Spahn the "Rheinische Post".
Compared to medicines, the barriers to medical device approval are extremely low - even when it comes to critical products such as pacemakers or hip replacements. After the scandal over faulty breast implants, the system was revised in 2017 throughout Europe.
Nevertheless, experts still criticize several problems: unlike medications, so-called Notified Bodies decide on the approval. However, these are financially dependent on the orders of the companies. Manufacturers may also choose a job throughout Europe. Extensive studies, which prove that the medical products are more useful than harm, the manufacturers do not have to present so far.
Data remains secret until now
So far it has hardly been possible for doctors and patients to compare different medical devices and to select the best one. This is partly because the data used to approve a product is often kept secret. On the other hand, a directory listing all available medical devices is missing. What patients should know about it, read here.
Spahn wants to change the last point. With the registry it is possible to inform all affected patients if problems occur with a product. Responsible healthcare facilities, affected patients and manufacturers would be required to participate in the register, the bill says.
The law should enter into force in early 2020. However, according to the Health Minister, the structure of the register will take three to five years. "Even if a product is in order, we gain insight into its durability and quality," explained Spahn.
Spahn also wants to accelerate the introduction of the electronic patient file by 2021, as agreed in the coalition agreement, by threatening the health insurance companies with penalties. "We will provide financial sanctions for the funds that do not fulfill this," he said. You would cut 2.5 percent for administrative expenses.